[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-brain-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-brain-tumor":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,59,85,105,133,168,194],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100528530","phase-2-study-of-olutasidenib-and-temozolomide-in-hgg-100528530",false,"NCT06161974","Study of Olutasidenib and Temozolomide in HGG","Phase 2 Study of Olutasidenib With Temozolomide as Maintenance Therapy in Pediatric and Young Adult Patients Newly Diagnosed With High-Grade Glioma (HGG), Including Diffuse Intrinsic Pontine Glioma (DIPG), Which Harbor IDH1 Mutations","Criteria TarGeT-D study strata definitions\n\n* Stratum A: Patients with localized, intracranial, non-pontine, and non-thalamic IDH 1 mutant Astrocytoma, CNS WHO Grade 3.\n* Stratum B: Patients with localized, intracranial, non-pontine, and non-thalamic IDH 1 mutant Astrocytoma, CNS WHO Grade 4.\n* Stratum C: Patients with IDH-1 mutant DIPG, primary thalamic and spinal cord IDH-1 mutant HGG.\n\nInclusion Criteria:\n\n1. Inclusion criteria already met to enroll on TarGeT-SCR (central molecular and histopathologic screening) based on:\n\n   1.1) Age: patients must be ≥12 years and ≤39 years of age at the time of enrollment on TarGeT-SCR 1.2) Diagnosis:\n   * Patients with a newly-diagnosed IDH1-mutant HGG including DIPG are eligible. All patients must have tumor tissue from diagnostic biopsy or resection, without exceptions. The diagnosis of HGG, including DIPG, must have been confirmed through TarGeT-SCR.\n   * For the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2\u002F3 of the pons, and histopathology consistent with diffuse WHO Grade 2-4 glioma.\n   * All other HGG must be WHO Grade 3 or 4.\n\n   1.3) Disease status: There are no disease status requirements for enrollment\n   * Measurable disease is not required. Patients without measurable disease are eligible.\n   * Primary spinal tumor: Patients with a primary spinal HGG are eligible.\n   * Patient must not have metastatic disease.\n2. Inclusion criteria for assignment to TarGeT-D, for all strata:\n\n2.1 Presence of at Least One Relevant Actionable Somatic Mutation in IDH1 Gene, Detailed Here:\n\n* R132H, R132C, R132S, R132G or R132L.\n* Patients whose tumors harbor other alterations in addition to IDH1 mutation will potentially be eligible following consensus recommendation by the international multidisciplinary molecular screening committee.\n* Patients with IDH2 mutations are not eligible.\n* Patients with oligodendroglioma, IDH-mutant and 1p\u002F19q-codeleted are not eligible.\n\n2.2 Weight: Patients must weigh ≥35 Kg (77 lbs) at the time of enrollment on TarGeT-D.\n\n2.3 Performance Level: Karnofsky ≥ 50% for patients \\> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n\n2.4 Prior Therapy 2.4.1 Surgery, radiation, and\u002For dexamethasone are permissible. Temozolomide administered concurrently with radiotherapy is permissible. Prior administration of bevacizumab is allowed, given at least 42-day washout period is completed prior to beginning treatment on TarGeT-D. No other prior anticancer therapy for HGG will be allowed.\n\n2.4.2 Radiation therapy requirements: RT, delivered via photon or proton beam, must have been administered at a standard dose including 54 Gy in 30 fractions for DIPG, 55-59.4 Gy in 30-33 fractions for other HGG or 45-54 Gy for primary spinal cord HGG. Any variances in the radiotherapy dose within 10% of the standard doses outlined above will be discussed with the Study Chair to confirm eligibility prior to study enrollment.\n\n2.4.3 Timing between diagnosis and start of RT: Patients must have started RT \\\u003C 42 calendar days of initial diagnosis defined as the date of diagnostic biopsy or resection; if a patient underwent two upfront surgeries (e.g., biopsy then resection or debulking), this is the date of the second surgery.\n\n* Patients in pre-maintenance phase must enroll and start treatment no later than 21 calendar days post-completion of RT.\n* Patients not in pre-maintenance phase must enroll and start treatment no later than 35 calendar days post-completion of RT.\n\n2.5 Organ Function Requirements 2.5.1 Adequate Bone Marrow Function Defined as:\n\n* Peripheral absolute neutrophil count (ANC) ≥ 1000\u002Fmm3.\n* Platelet count ≥ 100,000\u002Fmm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).\n* Hemoglobin \\> 8 g\u002FdL (may be transfused). 2.5.2 Adequate Renal Function Defined as\n* Creatinine clearance or radioisotope GFR ≥ 70ml\u002Fmin\u002F1.73 m2 OR\n* Maximum serum creatinine based on age\u002Fgender as follows: 10 to \\\u003C 13 yrs=1.2 mg\u002FdL for males and females. 13 to \\\u003C 16 yrs=1.5 mg\u002FdL for males and 1.4 mg\u002FdL for females.\n\n2.5.3 Adequate Liver Function Defined as:\n\n* Total bilirubin must be ≤ 1.5 × institutional ULN.\n* AST(SGOT)\u002FALT(SGPT) \\\u003C 3 × institutional ULN.\n* Alkaline Phosphatase \\\u003C 3 × institutional ULN. 2.5.4 Adequate Neurologic Function Defined as:\n\n  * Patients with seizure disorder may be enrolled if well-controlled on anticonvulsants that are not a strong inducer or inhibitor of CYP3A4\u002F5.\n  * Patients must be able to swallow oral medications to be eligible for study enrollment.\n\n2.6. Informed consent: All patients and\u002For their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.\n\nExclusion Criteria:\n\n1. Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study due to unknown potential risks of fetal and teratogenic adverse events as seen in animal studies. Pregnancy tests must be obtained in girls who are post-menarchal. Patients of childbearing or child fathering potential must agree to use one highly effective method of contraception while being treated on this study and for 3 months after completing therapy. A woman is considered of childbearing potential if she is fertile, following menarche and until becoming post-menopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy. Male participants should refrain from sperm donation throughout the duration of treatment and for 3 months after completion of therapy.\n\n   A highly effective contraception method is defined as one that results in a low failure rate (\\\u003C1% per year) when used consistently and correctly. The following are considered highly effective contraception methods:\n   * Combined estrogen and progesterone containing hormonal contraception associated with inhibition of ovulation.\n   * Progesterone-only hormonal contraception associated with inhibition of ovulation.\n   * Intra Uterine Device (IUD).\n   * Intra uterine hormone releasing system.\n   * Bilateral tubal occlusion.\n   * Vasectomized partner.\n   * Sexual abstinence (avoiding heterosexual intercourse).\n   * The following contraceptive measures are NOT considered effective:\n\n     * Progesterone-only hormonal contraception (birth control pill) that that does NOT stop ovulation.\n     * Male or female condom with or without spermicide.\n     * Cap, diaphragm, or sponge with spermicide.\n2. Using the following types of concomitant medications:\n\n   * Corticosteroids: Patients receiving corticosteroids are eligible. The use of corticosteroids must be reported.\n   * Investigational Drugs: Patients who are currently receiving another investigational drug are not eligible.\n   * Anti-cancer Agents: Concurrent anti-cancer agents are not allowed with the exception of temozolomide given concurrently with RT and as protocol-instructed post RT maintenance therapy after enrollment on TarGeT-D.\n   * Anticonvulsants: Patients who are receiving enzyme inducing anticonvulsants that are strong inducers of CYP3A4\u002F5 are not eligible.\n   * Strong CYP3A4\u002F5 inducers: Patients who are receiving strong inducers of CYP3A4\u002F5 are not eligible. Strong inducers of CYP3A4\u002F5 should be avoided from 14 days prior to or 5 half-lives (whichever is longer) enrollment to the end of the study.\n   * Patients who are receiving medications known to prolong QTc interval are not eligible\n   * Selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft) should be used with caution but are not contraindicated.\n3. Other Criteria\n\n   * Infection: Patients who have an uncontrolled infection are not eligible.\n   * Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study are not eligible.\n   * Patients with known clinically significant active malabsorption syndrome or other condition that could affect absorption are not eligible.\n   * Patients with malignancy related to HIV or solid organ transplant: known history of HIV, HBV surface antigen positivity or positive HCV antibody are not eligible. Viral testing is not required unless clinically indicated in patients without a known history.\n   * Patients with prior or ongoing clinically significant illness, medical or psychiatric condition, that, in the investigator's opinion, could affect the safety of the participant, or could impair the assessment of study results are not eligible.\n   * Patients with any prior solid organ transplant are not eligible.\n   * Patients with secondary\u002Fradiation-related HGG are not eligible.\n   * Patients with metastatic\u002Fdisseminated HGG who have received CSI are not eligible.","ALL","12 Years","39 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this study is to determine the efficacy of the study drug olutasidenib to treat newly diagnosed pediatric and young adult patients with a high-grade glioma (HGG) harboring an IDH1 mutation.\n\nThe main question the study aims to answer is whether the combination of olutasidenib and temozolomide (TMZ) can prolong the life of patients diagnosed with an IDH-mutant HGG.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45],"High Grade Glioma","Astrocytoma","Astrocytoma, Grade III","Astrocytoma, Grade IV","Diffuse Intrinsic Pontine Glioma","WHO Grade III Glioma","WHO Grade IV Glioma","Metastatic Brain Tumor","Diffuse Midline Glioma, H3 K27M-Mutant","Thalamus Tumor","Spinal Tumor","IDH1 Mutation","IDH1 R132","IDH1 R132C","IDH1 R132H","IDH1 R132S","IDH1 R132G","IDH1 R132L","Oligodendroglioma","RECRUITING","2026-06-10",{"date":49,"type":50},"2026-06-12","ACTUAL",{"date":52,"type":50},"2025-02-01",{"date":54,"type":21},"2035-06",{"name":56,"class":57},"Rigel Pharmaceuticals","INDUSTRY",20,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":16,"minAge":66,"maxAge":18,"enrollmentInfo":67,"targetDuration":4,"studyType":69,"phases":4,"briefSummary":70,"conditions":71,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100503755","targeted-pediatric-high-grade-glioma-therapy-100503755","NCT05839379","Targeted Pediatric High-Grade Glioma Therapy","Molecularly-Guided Phase II Umbrella Trial for Children, Adolescents, and Young Adults Newly Diagnosed With High-Grade Glioma, Including Diffuse Intrinsic Pontine Glioma","Inclusion Criteria:\n\n1. Age: Patients must be ≥12 months and ≤39 years of age at the time of enrollment onto this screening protocol.\n2. Diagnosis: Patients with newly diagnosed HGG, including DIPG are eligible. Diagnosis must have histologic confirmation from biopsy or resection. The diagnosis of HGG must have been confirmed by pathology review at the local site. For the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2\u002F3 of the pons, with histopathology consistent with diffuse WHO grade 2-4 glioma (eg, diffuse astrocytoma, anaplastic astrocytoma, glioblastoma, H3K27-altered diffuse midline glioma). For all other tumors, histologic grade must be WHO grade 3-4.\n3. Disease Status: There are no disease status requirements for enrollment.\n\n   * Measurable disease is not required. Patients without measurable disease are eligible.\n   * Patients with metastatic\u002Fdisseminated or multifocal disease or gliomatosis cerebri are eligible.\n   * Patients with a primary spinal tumor are eligible.\n   * Patients with secondary, radiation related HGG are eligible.\n4. Prior Therapy for HGG: Surgery, radiation, and\u002For dexamethasone are permissible. Temozolomide concurrent with radiation is permissible. Prior administration of avastin\u002Fbevacizumab is allowed (individual treatment arms have different washout period requirements, check individual arm eligibility). No other prior anticancer therapy for HGG will be allowed.\n\n   * Participants screening for assignment to TarGeT-L may not have received radiation.\n\n   Timing from surgery to start of RT: For patients who have started RT, radiation must have started \\\u003C42 days from definitive surgery or biopsy, however it is strongly recommended patients start RT within 31 days from definitive surgery (if patient had two surgeries, radiation must have started within 31 days from second surgery).\n5. Tumor Sample Availability OR results from previous molecular profiling\u002Ftargeted sequencing\n\n   * If a patient screens through OPTION #1, tumor sample in addition to normal comparator tissue (peripheral blood, saliva, or buccal swab) must be submitted for comprehensive molecular screening at the time of screening enrollment.\n   * If a patient screens through OPTIONS #2 or #3, results from previously performed molecular profiling must be submitted following enrollment. It is highly recommended that results be uploaded within 7 days of enrollment (if results are available at time of enrollment) or within 7 days of results becoming available (if pending at time of enrollment) to allow adequate time for central review.\n6. Informed Consent: All patients and\u002For their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.\n7. Enrollment timeline: Patients are eligible to enroll on the TarGeT-SCR anytime between diagnosis and the following specific timepoints post completion of RT (if relevant)\n\n   * Patients screening through OPTION #1 are eligible to enroll anytime between diagnosis and 10 days post RT (if completing RT).\n   * Patients screening through OPTIONS #2 or #3 are eligible to enroll anytime between diagnosis and 21 days post RT (if completing RT).\n   * Participants screening for TarGeT-L (lorlatinib) are eligible to enroll on TarGeT-SCR anytime between diagnosis and 31 days post definitive surgery (to allow time for molecular review).\n\nHowever, it is important to note the following:\n\n* For treatment protocols that include targeted therapy administered concurrently with RT, patients must start treatment within 10 calendar days of starting RT.\n* For treatment protocols that only include maintenance\u002Fadjuvant therapy (no systemic therapy given concurrently with radiation), patients must start treatment by 35 days post RT\n\n  #SCREENING OPTIONS\n* OPTION1: Molecular screening through CONNECT TarGeT Clinical Testing Laboratories\n* OPTION2: Molecular screening through a national comprehensive tumor profiling program\n* OPTION3: Clinically validated targeted sequencing or focused profiling\n\nExclusion Criteria:\n\n-Tumors that do not meet HGG and DIPG diagnoses specified above","12 Months",{"count":68,"type":21},350,"OBSERVATIONAL","The goal of this study is to perform genetic sequencing on brain tumors from children, adolescents, and young adult patients who have been newly diagnosed with a high-grade glioma. This molecular profiling will decide if patients are eligible to participate in a subsequent treatment-based clinical trial based on the genetic alterations identified in their tumor.",[27,31,72,73,74,35,34,32,33],"Anaplastic Astrocytoma","Glioblastoma","Glioblastoma Multiforme","2026-06-08",{"date":47,"type":50},{"date":78,"type":50},"2024-08-02",{"date":80,"type":21},"2034-08-28",{"name":82,"class":83},"Nationwide Children's Hospital","OTHER",21,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":66,"maxAge":18,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":104,"locationsCount":58},"100504051","phase-2-study-of-ribociclib-and-everolimus-in-hgg-and-dipg-or-ribociclib-and-temozolomide-in-dhg-h3g34-mutant-100504051","NCT05843253","Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant","Phase 2 Study of Ribociclib-Containing Post-Radiotherapy Combinations in Pediatric and Young Adult Patients Newly Diagnosed With High-Grade Glioma, Including Diffuse Intrinsic Pontine Glioma: Ribociclib and Everolimus for HGG\u002FDIPG Which Harbor Alterations of the Cell Cycle and\u002For PI3K\u002FmTOR Pathways AND Ribociclib and Temozolomide for DHG, H3G34-mutant","TarGeT-A study strata definitions Part1: Initial Feasibility Study for the combination of ribociclib PfOS formulation with everolimus: Enrollment on this cohort will be limited to patients aged \\\u003C21 years with primary intracranial localized HGG and DIPG\n\nPart 2\n\n* Stratum A: Patients with localized, intracranial, non-pontine, and non-thalamic HGG (who do not meet criteria for strata C-D)\n* Stratum B: Patients with DIPG\n* Stratum C: Patients with primary thalamic, spinal cord, and\u002For secondary\u002Fradiation-related HGG.\n* Stratum D: Patients with metastatic\u002Fdisseminated HGG, multifocal HGG, and\u002For gliomatosis cerebri who received CSI.\n\nStratum E\n\n* Stratum E: Patients with localized DHG, H3G34-mutant.\n\nInclusion Criteria:\n\n1. Inclusion criteria already met to enroll on TarGeT-SCR (central molecular and histopathologic screening) based on:\n\n   1.1) Age: patients must be ≥12 months and ≤39 years of age at the time of enrollment on TarGeT-SCR. For the Part 1 Initial Feasibility Cohort (receiving ribociclib and everolimus) only: patients must be \\\u003C21 years of age at the time of enrollment on this protocol.\n\n   1.2) Diagnosis: patients with newly-diagnosed HGG, including DIPG are eligible. All patients must have histologic confirmation tumor tissue from diagnostic biopsy or resection, without exceptions. The diagnosis of HGG, including DIPG, must have been confirmed through TarGeT-SCR:\n   * For the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2\u002F3 of the pons, with histopathology, consistent with diffuse WHO grade 2-4 glioma\n   * All other HGGs must be WHO grade 3 or 4.\n\n   1.3) Disease status: There are no disease status requirements for enrollment\n   * Patients without measurable disease are eligible.\n   * Patients with metastatic or multifocal disease or gliomatosis cerebri who received upfront CSI are eligible\n   * Patients with a primary spinal HGG are eligible\n   * Patients with secondary, radiation-related HGG are eligible.\n2. Inclusion criteria for assignment to TarGeT-A, for all strata:\n\n2.1) Presence of at least one relevant actionable somatic alteration, detailed here:\n\n* Pathogenic alterations presumed to cause activation of cell cycle:\n* Amplification of CDK4 or CDK6\n* Deletion of CDKN2A, CDKN2B, or CDKN2C\n* Amplification of CCND1 or CCND2\n* Pathogenic alterations presumed to cause activation of the PI3K\u002FmTOR pathway:\n* Deletion or mutation of PTEN\n* Mutation or amplification of PIK3CA\n* Mutation of PIK3R1\n* Deletion or mutation of TSC1 or TSC2\n* Patients with evidence of homozygous (biallelic) RB1 loss by sequencing are excluded from TarGeT-A\n* Patients whose tumors harbor other alterations suspected to activate the cell cycle and\u002For PI3K\u002FmTOR pathway could potentially also be eligible, but only following consensus recommendation by the international multidisciplinary molecular screening committee.\n* For Stratum E: H3G34 (R\u002FV) mutation\n\n2.2) Performance Level: Karnofsky ≥ 50% for patients \\> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of ag. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n\n2.3) Prior Therapy for HGG:\n\n* Surgery, RT, dexamethasone are permissible. Temozolomide administered concurrently with RT is permissible. Avastin\u002Fbevacizumab use is permitted given the last dose was administered \\> 21 days prior to enrollment. No other prior anticancer therapy for HGG will be allowed.\n* Patients must have received photon or proton RT.\n* Patients must have started RT \\\u003C 42 calendar days from initial diagnosis defined as the date of diagnostic biopsy or resection. If a patient underwent 2 upfront surgeries (e.g., biopsy then resection or debulking), this is the date of the second surgery.\n* RT delivered via photon or proton beam, must have been administered at a standard dose including (54 Gy in 30 fractions for DIPG, 54-59.4 Gy in 30-33 fractions), 45 Gy-54 Gy for primary spinal disease, and\u002For 36 Gy-39.6 Gy craniospinal for patients with spinal or leptomeningeal metastatic disease with supplemental boost to 45-54 Gy for metastasis within the thecal sac and 54 Gy-60 Gy for intracranial metastasis. Any variances in the radiotherapy dose within 10% of the standard doses outlined above will be discussed with the Sponsor-Investigator to confirm eligibility prior to study enrollment.\n* Patients must enroll and start treatment No later than 35 calendar days post-completion of RT. The earliest patients can begin protocol treatment is 28 calendar days post-completion of RT.\n\n2.4) Organ Function Requirements\n\n2.4.1) Adequate Bone Marrow Function Defined as:\n\n* Peripheral absolute neutrophil count (ANC) ≥ 1000\u002Fmm3\n* Platelet count ≥ 100,000\u002Fmm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)\n* Hemoglobin \\>8 g\u002FdL (may be transfused)\n\n2.4.2) Adequate Renal Function Defined as:\n\n* Creatinine clearance or radioisotope GFR ≥ 70ml\u002Fmin\u002F1.73 m2 OR\n* Maximum serum creatinine based on (Schwartz et al. J. Peds, 106:522, 1985) age\u002Fgender as follows: 1 to \\\u003C 2 years=0.6 mg\u002FdL for males and females; 2 to \\\u003C 6 years=0.8 mg\u002FdL for males and females; 6 to \\\u003C 10 years= 1.0 mg\u002FdL for males and females; 10 to \\\u003C 13 years=1.2 mg\u002FdL for males and females. 13 to \\\u003C 16 years=1.5 mg\u002FdL for males and 1.4 mg\u002FdL for females.\n\n2.4.3) Adequate Liver Function Defined as:\n\n* Total bilirubin must be ≤ 1.5 times institutional upper limit of normal for age\n* AST(SGOT)\u002FALT(SGPT) ≤ 3 times institutional upper limit of normal\n* Serum albumin ≥ 2g\u002FdL\n\n2.4.4) Adequate Cardiac Function Defined as:\n\n* Ejection fraction of ≥ 50% by echocardiogram\n* QTc ≤ 450 msec (by Bazett formula)\n\n2.4.5) Adequate Neurologic Function Defined as: Patients with seizure disorder may be enrolled if well-controlled on anticonvulsants that are not strong inducers or inhibitors of CYP3A4\u002F5.\n\n2.4.6) Adequate Pulmonary Function Defined as: No evidence of dyspnea at rest, and a pulse oximetry \\>94% on room air if there is clinical indication for determination.\n\n2.5) Ability to take medications by mouth: For ribociclib and everolimus strata, patients must be able to take study medications by mouth as administration via NG\u002FNJ\u002FG tube is not allowed.\n\n2.6) Informed Consent: All patients and\u002For their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines\n\n2.7) Contraception: Male and female patients of childbearing potential must be willing to use a highly effective contraception method.\n\nExclusion Criteria\n\n1. Pregnant or Breast-Feeding Pregnant or breast-feeding women will not be entered on this study due to known potential risks of fetal and teratogenic adverse events as seen in animal\u002Fhuman studies. Pregnancy tests must be obtained in girls who are post-menarchal. Patients of childbearing or child fathering potential must agree to use at least one highly effective method of contraception while being treated on this study and for 3 months after completing therapy. A woman is considered of childbearing potential if she is fertile, following menarche and until becoming post-menopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy. Male participants should refrain from sperm donation throughout the duration of treatment and for 3 months after completion of therapy\n\n   A highly effective contraception method is defined as one that results in a low failure rate (\\\u003C1% per year) when used consistently and correctly. The following are considered highly effective contraception methods:\n   * Combined estrogen and progesterone containing hormonal contraception associated with inhibition of ovulation.\n   * Progesterone-only hormonal contraception associated with inhibition of ovulation.\n   * Intra Uterine Device (IUD)\n   * Intra Uterine hormone releasing system\n   * Bilateral tubal occlusion\n   * Vasectomized partner\n   * Sexual abstinence (avoiding having heterosexual intercourse) The following contraceptive measures are NOT considered effective\n   * Progesterone-only hormonal contraception (birth control pill) that that does NOT stop ovulation\n   * Male or female condom with or without spermicide\n   * Cap, diaphragm or sponge with spermicide\n2. Concomitant Medications\n\n   * Patients receiving corticosteroids are eligible. The use of corticosteroids must be reported.\n   * Patients who are currently receiving another investigational drug are not eligible.\n   * Patients who are currently receiving other anti-cancer agents are not eligible, with the exception of temozolomide given concurrently with RT only.\n   * Patients who are receiving enzyme inducing anticonvulsants that are strong inducers or inhibitors of CYP3A4\u002F5 are not eligible.\n   * Patients who are receiving strong inducers or inhibitors of CYP3A4\u002F5 are not eligible and should be avoided from 14 days prior to enrollment to the end of the study.\n   * Patients who are receiving medications known to prolong QTc interval are not eligible.\n   * Patients who are receiving therapeutic anticoagulation with warfarin or other coumadin-derived anticoagulants are not eligible. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed as long as the patient has adequate coagulation defined as aPTT \\\u003C 1.5Xs ULN and INR \\\u003C 1.5.\n3. Patients who have an uncontrolled infection are not eligible.\n4. Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study are not eligible.\n5. Patients with known clinically significant active malabsorption syndrome or other condition that could affect absorption are not eligible.\n6. Patients with prior or ongoing clinically significant medical or psychiatric condition that, in the investigator's opinion, could affect the safety of the subject, or could impair the assessment of study results are not eligible.",{"count":93,"type":21},120,[24],"The goal of this study is to determine the efficacy of the 1) ribociclib and everolimus to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in pathways (cell cycle, PI3K\u002FmTOR) that these drugs target or 2) ribociclib and temozolomide to treat pediatric and young adult patients newly diagnosed with diffuse hemispheric glioma (DHG), H3G34-mutant.\n\nThe main question the study aims to answer is whether the combinations of ribociclib and everolimus or ribociclib and temozolomide can prolong the life of patients diagnosed with HGG\u002FDIPG or DHG H3G34-mutant.",[27,31,72,73,74,35,34,32,33,97],"Diffuse Hemispheric Glioma, H3 G34-Mutant","2026-05-27",{"date":100,"type":50},"2026-05-29",{"date":102,"type":50},"2024-08-22",{"date":80,"type":21},{"name":82,"class":83},{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":66,"maxAge":18,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":115,"conditions":116,"keywords":121,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":4},"100608845","phase-2-study-of-tovorafenib-in-high-grade-glioma-and-diffuse-intrinsic-pontine-glioma-dipg-100608845","NCT07206849","Study of Tovorafenib in High-Grade Glioma and Diffuse Intrinsic Pontine Glioma (DIPG)","A Phase 2 Study of Tovorafenib in Pediatric and Young Adult Patients Newly Diagnosed With High-Grade Glioma (HGG), Including Diffuse Intrinsic Pontine Glioma (DIPG), Which Harbor Alterations in the Mitogen-Activated Protein Kinase (MAPK) Pathway","Inclusion Criteria:\n\n* Patient must have previously enrolled on TarGeT-SCR.\n\n  1. Age Patients must be ≥12 months and ≤39 years of age at the time of enrollment on TarGeT-SCR.\n  2. Body Surface Area (BSA) Patients must have a BSA \\>0.3m2.\n  3. Diagnosis:\n\n     * Patients with a newly-diagnosed HGG, including DIPG, which harbor alterations in the MAPK pathway are eligible. All patients must have tumor tissue from diagnostic biopsy or resection. The diagnosis of HGG, including DIPG, must have been confirmed through TarGeT-SCR.\n     * For the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2\u002F3 of the pons, with histopathology consistent with diffuse WHO Grade 2-4 glioma.\n     * All other HGGs must be WHO Grade 3 or 4.\n  4. Disease Status\n\n     • Patients must be newly diagnosed and enroll and start treatment within 35 days of completion of radiotherapy.\n\n     • Measurable disease is not required. Patients without measurable disease are eligible.\n     * Patients with primary spinal tumors are eligible.\n     * Patients with secondary or radiation-induced HGG are eligible.\n  5. TarGeT-B Strata Definitions\n\n     Patients must be able to be assigned to one of the strata below:\n\n     • Stratum A: Patients with intracranial, localized, non-pontine, and non-thalamic HGG harboring a BRAFV600 mutation (who do not meet criteria for Strata B or C).\n     * Stratum B: Patients with DIPG\u002FDMG as defined in Section 4.1.3 OR patients with localized, non-pontine, non-thalamic HGG harboring a MAPK alteration not included in Stratum A (KIAA1549:BRAF fusion, KRAS\u002FNRAS, CRAF\u002FRAF1, other RAF mutation, or FGFR alteration) OR patients with primary spinal tumors.\n     * Stratum C: Patients with metastatic HGG (including metastatic DIPG\u002FDMG) harboring a MAPK alteration (BRAFV600, KIAA1549:BRAF fusion, KRAS\u002FNRAS, CRAF\u002FRAF1, other RAF mutation, or FGFR alteration).\n  6. Presence of at least one relevant actionable somatic alteration:\n\n     • MAPK pathway alteration(s): BRAFV600 mutation (Strata A or C)\n     * KIAA1549:BRAF fusion (Strata B or C)\n     * KRAS\u002FNRAS alteration (Strata B or C)\n     * CRAF\u002FRAF1 alteration (Strata B or C)\n     * other RAF mutations (Strata B or C)\n     * FGFR alteration (Strata B or C)\n  7. Performance Level:\n\n     Karnofsky ≥ 50 for patients \\> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age (Appendix I). Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n  8. Prior Therapy for HGG:\n\n     o Surgery, radiation (RT), and\u002For dexamethasone are permissible. Temozolomide administered concurrently with RT is permissible but discouraged for patients with DIPG\u002FDMG. No other prior anticancer therapy for HGG will be allowed.\n\n     o Radiation therapy requirements: Patients must have received photon or proton focal radiotherapy if enrolling on Stratum A or B. Patients must have received craniospinal irradiation if enrolling on Stratum C.\n\n     o Radiotherapy, delivered photon or proton beam, must have been administered at a standard dose, including:\n\n     o 54 Gy in 30 fractions for DIPG\n\n     o 54-59.4 Gy in 30-33 fractions for other HGG\n\n     o 45-54 Gy for primary spinal cord HGG\n\n     o And\u002For 36-39.6 Gy craniospinal for patients with spinal or leptomeningeal metastatic disease with supplemental boost to 45-54 Gy for metastasis within the thecal sac and 54-60 Gy for intracranial metastasis.\n\n     o Any variances in the radiotherapy dose within 10% of standard doses outlined above will be discussed with the Sponsor-Investigator to confirm eligibility prior to study enrollment.\n\n     o Timing between diagnosis and start of RT: Patients must have started RT within 31 calendar days of initial diagnosis which is defined as the date of diagnostic biopsy or resection. If a patient underwent two upfront surgeries e.g., biopsy then resection or debulking, this is the date of the second surgery.\n     * Timing post-RT: Patients must enroll and start treatment on TarGeT-B no later than 35 calendar days post-completion of RT. The earliest patients can begin protocol treatment is 28 calendar days post-completion of RT.\n  9. Organ Function Requirements\n* Adequate Bone Marrow Function Defined as:\n\n  • Peripheral absolute neutrophil count (ANC) \\>= 1000\u002Fmm3.\n\n  • Platelet count \\>= 100,000\u002Fmm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).\n\n  • Hemoglobin \\>8 g\u002FdL (may be transfused).\n* Adequate Renal Function Defined as:\n\nCreatinine clearance or radioisotope GFR \\> 70ml\u002Fmin\u002F1.73 m2 OR serum creatinine based on age\u002Fgender as follows:\n\nMaximum Serum Creatinine (mg\u002FdL) Age Male Female 1 to \\\u003C 2 years 0.6 0.6 2 to \\\u003C 6 years 0.8 0.8 6 to \\\u003C 10 years 1 1 10 to \\\u003C 13 years 1.2 1.2 13 to \\\u003C 16 years 1.5 1.4\n\n* 16 years 1.7 1.4 The threshold creatinine values in this table were derived from the Schwartz formula for estimating GFR (Schwartz et al. J. Peds, 106:522, 1985) utilizing child length and stature data published by the CDC.\n\n  * Adequate Liver Function Defined as:\n\n    * Total bilirubin ≤ 1.5 times institutional upper limit of normal (ULN).\n    * Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) \\\u003C 3 times the ULN.\n    * Serum albumin ≥ 2g\u002FdL.\n  * Adequate Cardiac Function Defined as:\n\n    • Left Ventricular Ejection fraction of ≥ 50% as measured by echocardiogram or multiple-gated acquisition (MUGA).\n    * QTc ≤ 450 msec (by Bazett formula).\n  * Adequate Neurologic Function Defined as:\n\n    * Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled (see Appendix II).\n  * Normal Thyroid Function Defined as:\n\n    • Free throxine (T4) within institutional guidelines for normal range. It is acceptable for patient to be on thyroid supplementation as long as free T4 is within institutional guidelines for normal range prior to starting treatment.\n\n    10\\) Informed Consent All patients and\u002For their parents or legally authorized representatives must sign a written Informed Consent and Assent, when appropriate, will be obtained according to institutional guidelines.\n\nExclusion Criteria:\n\n1. Pregnancy or breastfeeding.\n2. Other Exclusion Criteria\n\n   • Patients with neurofibromatosis type 1 (NF-1) are not eligible for this study.\n\n   • Infection: Patients who have an uncontrolled infection are not eligible.\n\n   • Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study are not eligible.\n\n   • Patients with uncontrolled GI disease or other condition that could affect absorption or predispose participant to gastrointestinal ulceration are not eligible.\n3. Concomitant Medications • Corticosteroids: Patients receiving corticosteroids are eligible, but the use of corticosteroids must be reported.\n\n   • Investigational Agents\u002FDrugs: Patients who are currently receiving another investigational drug are not eligible. This includes targeted agents, monoclonal antibodies, herbal supplements, or other investigational agents other than tovorafenib.\n\n   • Anti-cancer Agents: Patients who are currently receiving other anti-cancer agents are not eligible with the exception of temozolomide given concurrently with radiotherapy.\n\n   • Anticonvulsants: Patients who are receiving enzyme-inducing anticonvulsants as listed in Appendix II, are not eligible.\n\n   • Patients who are receiving medications known to prolong QTc interval as listed in Appendix III are not eligible.\n\n   • As tovorafenib is a substrate of CYP2C8, patients should not take strong inhibitors or inducers of CYP2C8 (See Appendix VI), as they could alter the drug's pharmacokinetics. Medications that are substrates of CYP2C8 or CYP3A4 are allowed but should be used with caution.\n\n   • Medications that are substrates of breast cancer resistance protein (BCRP) with a narrow therapeutic index are prohibited during this study (Appendix IV).\n   * Patients who are receiving duloxetine, alosetron, or theophylline (CYP1A2 inhibitors) are not eligible.\n   * Patients on beta-blockers are not eligible.\n   * Selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), Fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft) should be used with caution but are not contraindicated.\n   * Anticoagulants: patients who are receiving therapeutic anticoagulants including warfarin, low-molecular weight heparin are not eligible.\n\n5\\) Patients with prior or ongoing clinically significant medical or psychiatric condition that, in the investigator's opinion, could affect the safety of the participant, or could impair the assessment of study results are not eligible.",{"count":113,"type":21},79,[24],"The goal of this study is to determine the efficacy of the study drugs tovorafenib to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in pathways (MAPK) that this drug targets.\n\nThe main question the study aims to answer is whether tovorafenib can prolong the life of patients diagnosed with HGG, including DIPG.",[117,118,31,27,119,120,34],"High Grade Glioma (HGG) of the Brain With BRAF Aberration","High Grade Glioma (III or IV)","WHO Grade 3 Glioma","WHO Grade 4 Glioma",[122,123],"tovorafenib","high grade glioma","NOT_YET_RECRUITING","2026-04-03",{"date":127,"type":50},"2026-04-08",{"date":129,"type":21},"2026-05",{"date":131,"type":21},"2037-05",{"name":82,"class":83},{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":140,"sex":16,"minAge":141,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":69,"phases":4,"briefSummary":144,"conditions":145,"keywords":149,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},"100482271","developing-a-new-mri-technique-to-understand-changes-in-brain-tumors-after-treatment-100482271","NCT05559853","Developing a New MRI Technique to Understand Changes in Brain Tumors After Treatment","Development of a Clinical CEST MR Fingerprinting Method for Treatment Response Assessment in Brain Metastases","Inclusion Criteria:\n\nHealthy volunteers \\[for Study Aim 1 (SA1) and Study Aim 2 (SA2)\\] will be entered into the study if they meet the following criteria:\n\n* Age ≥ 18 years\n* Able to understand and give informed consent\n* No known cancer diagnosis\n\nPatients \\[for Study Aim 1 (SA1)\\] will be entered into the study if they meet the following criteria:\n\n* Age ≥ 18 years\n* Able to understand and give informed consent\n* At least one untreated brain metastasis \\> 1cm (e.g., an enhancing lesion in the brain of a patient with known systemic cancer determined likely to represent metastasis by neuroradiologist)\n\nPatients \\[for Study Aim 3 (SA3)\\] will be entered into the study if they meet the following criteria:\n\n* Age ≥ 18 years\n* Able to understand and give informed consent\n* At least one untreated brain metastasis \\> 1cm (e.g., an enhancing lesion in the brain of a patient with known systemic cancer determined likely to represent metastasis by neuroradiologist)\n* Planned SRS treatment\n\nExclusion Criteria:\n\nHealthy volunteers (SA1 \\& SA2) and patients (SA1 \\& SA3) exclusion criteria:\n\n* Pregnant or breastfeeding women\n* Pre-existing medical conditions, including the likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest\n* Age \\\u003C 18 years",true,"18 Years",{"count":143,"type":21},119,"The purpose of this study is to develop and test a new magnetic resonance imaging (MRI) technique to see if it can be used to tell the difference between tumor growth from worsening of cancer and growth from the effects of treatment in participants who have brain tumors treated with radiation therapy called stereotactic radiosurgery (SRS).",[146,147,34,148],"Brain Metastases","Brain Metastases, Adult","Metastatic Brain Cancer",[146,150,151,152,147,153,154,155,156,157,158],"Healthy Volunteers","metastatic brain tumor","metastatic brain cancer","MRI","untreated brain metastasis","CEST-MRF","chemical exchange saturation transfer magnetic resonance fingerprinting","22-191","Memorial Sloan Kettering Cancer Center","2026-03-04",{"date":161,"type":50},"2026-03-06",{"date":163,"type":50},"2022-09-22",{"date":165,"type":21},"2027-09-22",{"name":158,"class":83},1,{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":141,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":177,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":167},"100482011","phase-1-f-tryptophan-petct-in-human-cancers-100482011","NCT05556473","F-Tryptophan PET\u002FCT in Human Cancers","A Pilot Study of 1-(2-[18f]Fluoroethyl)-L-Tryptophan PET\u002FCT Imaging In Human Cancers","Inclusion Criteria:\n\n* Age ≥18 years.\n* Targeted lesion (tumor) is at least 1 cm in diameter as shown by clinical imaging.\n* Patient is able to lie in the PET\u002FCT scanner for at least 70 minutes while undergoing scanning.\n* Women of childbearing potential must not be pregnant or breastfeeding.\n* Recent anatomic imaging with visible disease (tumor) for comparison with the PET\u002FCT. .\n* Physical exam within 28 days of PET imaging, CBC and Multiphasic (including electrolytes, BUN, creatinine, total bilirubin, AST and ALT) within 14 days.\n* Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.\n\nInclusion Criteria Specific for Intracranial Tumors\n\n\\- Clinical and MRI diagnosis of an intracranial lesion suspicious for a brain tumor, including gliomas or metastatic brain tumors; primary, residual, or recurrent brain tumors (judged by clinical imaging) will qualify.\n\nInclusion Criteria Specific for Extracranial Neuroendocrine Tumors:\n\n* Histopathologically confirmed, well-differentiated metastatic neuroendocrine tumor.\n* ECOG performance status of 2 or better.\n* Patients receiving stable-dose somatostatin analogs (SSAs, long-acting release \\[LAR\\], depot) for \\>3 months before enrollment may be enrolled on the study, but such treatment is not required.\n\nInclusion Criteria specific for Extracranial Primary Breast tumors:\n\n* Clinical and radiological diagnosis of a breast cancer\n* ECOG performance status of 2 or better.\n\nInclusion Criteria specific for Rectal tumors:\n\n* Histologically confirmed colorectal cancer, which is located in the rectum.\n* ECOG performance status of 2 or better.\n\nExclusion Criteria:\n\n* Patients who are pregnant or lactating are excluded.\n\nExclusion Criteria Specific for Intracranial Tumors:\n\n* Severe increased intracranial pressure, status epilepticus, or other symptoms requiring emergency or urgent intervention.\n* Tumor surgery or radiation within 1 month prior to the PET scan\n\nExclusion Criteria Specific for Extracranial Neuroendocrine Tumors:\n\n* Tumor-directed therapy within 3 months to the area of planned imaging.\n* Ongoing treatment with a targeted agent (e.g., sunitinib or everolimus) or receiving cytotoxic chemotherapy (e.g., capecitabine or temozolomide).\n* Use of telotristat ethyl (a tryptophan-hydroxylase inhibitor) within one month.\n\nExclusion Criteria for Extracranial Primary Breast tumors:\n\n-Recent (within 1 month) tumor resection or radio-chemotherapy (acute\u002Fsubacute post-treatment inflammatory changes may cause false positive increases on PET).\n\nExclusion Criteria for Rectal tumors:\n\n-Active inflammatory bowel disease (Crohn's or Ulcerative colitis) involving the rectum.",{"count":176,"type":21},24,[178],"PHASE1","Imaging procedures such as 1-(2-\\[18F\\]FLUOROETHYL)-L-Tryptophan PET\u002FCT in patients with cancers may help doctors assess a patient's response to treatment and help plan the best treatment in the future. The purpose is to see if there can be a better differentiation of tumor and non-tumor tissue where the tumor tissue has a higher uptake of Tryptophan.",[181,34,182,183,184],"Intracranial Glioma","Breast Cancer","Neuroendocrine Tumors","Rectal Cancer","2026-01-21",{"date":187,"type":50},"2026-01-23",{"date":189,"type":50},"2022-09-29",{"date":191,"type":21},"2027-12-31",{"name":193,"class":83},"Barbara Ann Karmanos Cancer Institute",{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":201,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":69,"phases":4,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":167},"100173728","assessment-of-eloquent-function-in-brain-tumor-patients-100173728","NCT01535430","Assessment of Eloquent Function in Brain Tumor Patients","Assessment of Reorganization and Plasticity of Eloquent Function in Patients With Brain Tumors","Inclusion Criteria:\n\n* 19 years and older\n* Brain tumor in or near eloquent brain regions that is appropriate for attempted resection\n* Appropriate body habitus and mental status\u002Fcapacity to participate with non-invasive or invasive mapping\n* Benign or malignant intra-axial brain tumor\n* Primary or metastatic intra-axial brain tumor\n\nExclusion Criteria:\n\n* Any contraindication to MRI (i.e. implanted devices)\n* Inappropriate body habitus or mental status\u002Fcapacity to participate with non-invasive or invasive mapping in a safe and reliable manner\n* Declining to participate\n* Lacks capacity to understand the study or consent for themselves\n* Neurologic status which precludes testing (poor function- not testable)\n* Positive pregnancy test\n* End stage renal disease or severe renal dysfunction","19 Years",{"count":203,"type":21},75,"Purpose of the study:\n\nAIM 1: Prospectively collect pre-operative \\[functional magnetic resonance imaging (fMRI), diffusion tensor imaging (DTI), magnetoencephalography (MEG)\\] and intra-operative mapping data in patients with intra-axial brain tumors to assess how well each modality predicts the location of eloquent brain function. In addition, each modality will be compared with the other.\n\nAIM 2: Assess reorganization of eloquent brain function and plasticity in patients with intra-axial brain tumors. This will be accomplished by prospectively collecting post-operative mapping studies and neuropsychological tests to compare them to prior mapping studies as stated above.",[206,34],"Primary Brain Tumor",[208,209],"brain mapping","brain tumor","2026-01-09",{"date":212,"type":50},"2026-01-13",{"date":214,"type":50},"2012-01-31",{"date":216,"type":21},"2027-12",{"name":218,"class":83},"University of Nebraska"]