[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"idh-mutation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:idh-mutation":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,78,108,131],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100612945","phase-2-phase-ii-study-evaluating-ivosidenib-maintenance-after-soc-adjuvant-chemotherapy-in-curative-midh1-cholangiocarcinoma-100612945",false,"NCT07260175","Phase II Study Evaluating Ivosidenib Maintenance After SOC Adjuvant Chemotherapy in Curative mIDH1 Cholangiocarcinoma","adIVO - A Phase II Trial of Ivosidenib Maintenance After SOC Adjuvant Chemotherapy in Curative mIDH1 Cholangiocarcinoma","adIVO","Inclusion Criteria:\n\n1. Patient\\* provides signed informed consent.\n2. Patient is ≥ 18 years at the time of given informed consent.\n3. Patient has histologically documented curatively resected intrahepatic cholangiocarcinoma, without metastatic spread, in the adjuvant situation (R0-resected)\n4. Patient has proven IDH1 mutation (IDH1-variant status evaluated locally by certified test on formalin-fixed paraffin-embedded tumor tissue specimen. If local testing for screening is not possible per local standard, tumor tissue samples will be subject to pre-screening via central IDH1 dPCR)\n5. Patient finished adjuvant systemic SOC chemotherapy (with regimens allowed per the protocol) directly prior to trial inclusion.\n6. Radiologic imaging available that shows that patient is tumor free at the timepoint of enrollment (not older than 6 weeks from the day of inclusion).\n7. Patient has ECOG Performance status ≤ 1\n8. Hematological, hepatic and renal function parameters adequate to allow targeted therapy with ivosidenib at investigator´s discretion and IB.\n9. Patient has adequate coagulability to allow targeted therapy with ivosidenib at investigator´s discretion and IB. Patients receiving warfarin \u002F Phenprocoumon must be switched to low molecular weight heparin and before starting trial-specific.\n10. Patient must be willingly to provide liquid biopsy samples, archival tumor tissue samples (if available), and in the event of disease recurrence, re-biopsy samples (if re-biopsy is considered safe for the patient) for the translational research program.\n11. Female patients of childbearing potential or male patients with female partners of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \\\u003C1% per year during the treatment period and for at least 6 months after the last dose of trial treatment. Male patients with a pregnant partner must agree to remain abstinent or to use a condom for the duration of the pregnancy. Female patients of child-bearing potential must have a negative pregnancy test within the last 7 days prior to the start of trial therapy.\n12. Patient is willing and able to comply with the protocol (including contraceptive measures) for the duration of the trial including undergoing treatment and scheduled visits and examinations including follow up.\n\nExclusion Criteria:\n\n1. Patient has a metastatic or R+ resected biliary tract cancer.\n2. Patient received previous therapy with an IDH1 inhibitor.\n3. Patient has known presence of tumors other than intrahepatic cholangiocarcinoma or a secondary tumor other than squamous or basal cell carcinomas of the skin or in situ carcinomas of the cervix which have been effectively treated. The sponsor decides to include patients who have received curative treatment and have been disease-free for at least 5 years.\n4. Simultaneous, ongoing systemic immunotherapy, chemotherapy, or hormone therapy not described in the trial protocol.\n5. Patient receives simultaneous treatment with a different anti-cancer therapy other than that provided for in the trial (excluding palliative radiotherapy only for symptom control).\n6. Patient has a stage B cirrhosis according to Child-Pugh criteria (or worse) or cirrhosis (of any grade) with a history of hepatic encephalopathy or clinically significant ascites resulting from cirrhosis. Clinically significant ascites is defined as ascites resulting from cirrhosis requiring diuretics or paracentesis.\n7. Patient has known allergic \u002F hypersensitive reactions to at least one of the treatment components.\n8. Patient has other serious illnesses or medical ailments within the last 12 months prior to the start of the trial.\n9. Patient has a known presence of an active, uncontrollable infection.\n10. Patient has QTc \\> 480ms or other factors that, in the discretion of the investigator increase significantly the risk of QT prolongation or arrhythmic events (e.g. heart failure, hypokalemia, family history of long QT syndrome). NOTE: Medications that prolong the QT interval should be avoided, unless they can be transferred to other medication within ≥ 5 half-lives to dosing or unless the medications can be properly monitored during the study. (If equivalent medication is not available, QTc should be closely monitored).\n11. Patient has active disseminated intravascular coagulation.\n12. Patient has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n13. Patient has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial drug.\n14. Patient has any other serious concomitant or medical condition that, in the opinion of the investigator, presents a high risk of complications to the patient or reduces the likelihood of clinical effect. NOTE: strong CYP3A4 inducers or sensitive CYP3A4 substrates with narrow therapeutic window should be avoided, unless they can be transferred to alternative medication within at least 5-half lives prior to dosing.\n15. Female patient is pregnant or breast feeding or planning to become pregnant within and 6 months after the end of treatment.\n16. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities.","ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study trial is a prospective, multicentre, exploratory, single-arm, open-label phase II study to evaluat ivosidenib maintenance after SOC adjuvant chemotherapy in curative mIDH1 cholangiocarcinoma",[27,28],"Cholangiocarcinoma","IDH Mutation",[30,31,32,33],"mIDH1 cholangiocarcinoma","ivosidenib maintenance","cholangiocarcinoma","R0-resection","RECRUITING","2026-06-03",{"date":37,"type":38},"2026-06-04","ACTUAL",{"date":40,"type":38},"2025-11-18",{"date":42,"type":21},"2031-12",{"name":44,"class":45},"Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest","OTHER",12,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100564975","early-phase-1-window-of-opportunity-study-of-dsp-0390-in-gliomas-100564975","NCT06636162","Window of Opportunity Study of DSP-0390 in Gliomas","Early Phase 1 Window of Opportunity Study of Oral DSP-0390 in Gliomas","Inclusion Criteria\n\n* Patients must have either newly diagnosed and suspected glioma per radiographic features, or radiographic recurrence of a histologically confirmed IDH-mutant glioma with the following grade requirements:\n\n  * ARM A: suspected lower grade glioma, or histologically confirmed grade II IDH-mutant glioma OR\n  * ARM B: suspected high grade glioma, or histologically confirmed grade III or IV glioma.\n* Patient must be a candidate for surgical resection\n* At least 18 years of age.\n* Karnofsky ≥ 70%\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1.5 K\u002Fcumm (patient may not use G-CSF or GM-CSF to achieve this ANC level)\n  * Platelets ≥ 100 K\u002Fcumm\n  * Hemoglobin ≥ 9 g\u002FdL (patient may not receive transfusion or use erythropoietin to obtain this Hgb level)\n  * Total bilirubin ≤ 1.5 x IULN (or ≤ 3 x IULN for patients with known Gilbert's syndrome)\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN\n  * International normalized ratio (INR), prothrombin time (PT), partial thromboplastin time (PTT), or activated partial thromboplastin time (aPTT) ≤1.5 x ULN. The use of anticoagulants is permitted as long as the PT\u002F(a)PTT is within therapeutic limits (according to the local institution standard) and the patient has been on a stable anticoagulant regimen for at least 2 weeks prior to Day 1.\n  * Creatinine Clearance of ≥40 mL\u002Fmin per Cockroft-Gault formula or by a 24 hour urine.\n* If a patient is using an antiepileptic medication, the patient is on a stable dose and without seizures for 14 days prior to Day 1. The antiepileptic medication used must not fall under any prohibited therapy category as defined in the protocol.\n* If the patient is receiving corticosteroids at baseline, the dose administered is stable or decreasing for at least 5 days prior to Day 1. A higher stable dose of corticosteroids, if used as hormone replacement therapy, may be allowed upon discussion with the sponsor-investigator.\n* The effects of DSP-0390 on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (2 forms of acceptable contraception, including one barrier method) prior to study entry, for the duration of study participation, and for 6 months after the last dose of DSP-0390. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.\n* Ability to understand and willingness to sign an IRB approved written informed consent document.\n\nExclusion Criteria\n\n* Patient has had prior therapy with bevacizumab or other anti-vascular endothelial growth factor (VEGF) treatments within 3 months prior to Day 1.\n* Patient has multifocal disease, leptomeningeal metastasis, or extracranial metastasis.\n* Patient has a clinically significant abnormal ECG, including those where QT prolongation is determined by the Fridericia formula (QTcF \\>450 msec for males and \\>470 msec for females); and\u002For the patient has a history of Torsade de Pointes.\n* Patient is known to have dysphagia, short-gut syndrome, gastroparesis, or other condition that may limit the ingestion or gastrointestinal absorption of drugs administered orally.\n* Patient is known to have active Crohn's or other inflammatory bowel disease.\n* A history of other malignancy for which all treatment was completed at least 2 years before Day 1 and the patient has no evidence of disease. Exceptions include non-melanoma skin cancer, cervical carcinoma in situ, and superficial bladder cancer that has been removed or curatively treated.\n* On active treatment for other, unrelated malignancy or currently receiving any other investigational agents.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to DSP-0390.\n* Patient has taken concurrent use of prohibited medications: carbamazepine, phenytoin, phenobarbital, and other strong or moderate CYP3A4 inhibitors or inducers, and strong CYP2D6 inhibitors within 1 week or 5 half-lives (whichever is greater) prior to Day 1 or expects to use them during the study. Note both oral and IV ondansetron at doses ≤ 8mg q6 hours are permitted.\n* The presence of any active retinal abnormality determined by screening ophthalmologic examination.\n* Patient has significant cardiovascular disease, including New York Heart Association (NYHA) Class III or IV congestive heart failure, myocardial infarction, unstable angina, pectoris, clinically significant cardiac arrhythmias, or stroke in the preceding 6 months prior to Day 1.\n* Uncontrolled intercurrent illness including, but not limited to, psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, disorders associated with significant immunocompromised state, or ongoing or active infection.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of DSP-0390.\n* Patients with HIV are eligible unless their CD4+ T-cell counts are \\\u003C350 cells\u002FmcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended, as long as the ART agents do not fall under exclusion #8.\n* Patient has a known detectable viral load for hepatitis C, or evidence of a hepatitis B surface antigen.\n* Patient has had a major non-neurologic surgical procedure, surgical resection, open biopsy, or significant traumatic injury within 4 weeks prior to Day 1 or anticipates needing a major surgical procedure during the course of the study.\n* Patient has had a minor surgical procedure, fine needle aspirations, or core biopsies within 7 days prior to Day 1.\n* Patient has received chemotherapy or investigational anticancer therapy within 4 weeks (except 6 weeks for nitrosoureas and immunotherapy, or 8 weeks for an implanted nitrosoureas wafer) prior to Day 1.\n* Patient has had radiotherapy within 12 weeks prior to Day 1, unless relapse is confirmed by tumor biopsy.",{"count":55,"type":21},20,[57],"EARLY_PHASE1","This study focuses on determining the pharmacokinetic and pharmacodynamic effect of DSP-0390 in brain and blood from patients with IDH-mutant glioma undergoing tumor resection. Tissue will be collected during surgical resection. Blood will be drawn at various time points throughout the 2 weeks of treatment. The hypothesis is that DSP-0390 will accumulate in brain tumor tissue at pharmacologically relevant concentrations, and that alterations in cholesterol metabolism driven by mutant IDH will increase susceptibility to DSP-0390 and lead to tumor cell death.",[60,28],"Glioma, Malignant",[62,63,64,65,66,67],"DSP-0390","IDH-mutant glioma","brain tumor","brain cancer","low grade glioma","high grade glioma","2026-04-30",{"date":70,"type":38},"2026-05-06",{"date":72,"type":38},"2025-04-03",{"date":74,"type":21},"2027-05-17",{"name":76,"class":45},"Washington University School of Medicine",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":77},"100635013","patient-voice-in-the-treatment-of-low-grade-gliomas-use-of-patient-reported-outcomes-vorasidenib-and-radiotherapy-compared-100635013","NCT07547163","Patient Voice in the Treatment of Low-grade Gliomas: Use of Patient-reported Outcomes, Vorasidenib and Radiotherapy Compared","LGG PRO's","Inclusion Criteria:\n\n* Age \\> 18 years\n* Histological diagnosis of IDH mutant, grade 2 glioma\n* Consent to treatment\n* Consent to the administration of PROM questionnaires\n\nExclusion Criteria:\n\n* Cognitive impairment or mental disability.\n* Dementia or severe cognitive disorders: participants who are unable to understand the questionnaire items are excluded, as the data may not be reliable.\n* Uncontrolled severe psychiatric disorders: conditions such as schizophrenia or untreated psychosis may compromise the patient's ability to provide consistent responses.\n* Language barriers.\n* Inability to understand the language of the questionnaire: participants who do not speak or understand the language in which the questionnaire is written are excluded if validated translations are not available.\n* Literacy issues: participants who are unable to read or write are excluded.\n* Non-adherence or poor cooperation.\n* Refusal to complete the questionnaires: even if the patient agrees to participate in the study, the specific refusal to complete the questionnaires leads to exclusion.\n* Conditions that may influence questionnaire outcomes.\n* Use of medications that impair cognitive abilities: the use of sedatives or antipsychotics may affect the ability to provide coherent responses, compromising the validity of PROs.",{"count":86,"type":21},90,"OBSERVATIONAL","The study aims to assess the direct patient-reported perception (PROs) of individuals affected by IDH-mutant, grade 2 gliomas undergoing radiotherapy or pharmacological treatment with vorasidenib.\n\nTo evaluate quality of life, perception of treatment-related symptoms, and anxiety levels during therapy by comparing patients receiving radiotherapy with those receiving pharmacological treatment with vorasidenib. The control group will consist of patients with IDH-mutant, grade 2 gliomas who are under clinical and radiological follow-up only.\n\nTo assess the feasibility of using PROMs in routine clinical practice. To analyze patient-reported critical issues in order to qualitatively improve care pathways.",[90,91,92,93,28],"Glioma","Glioma of Brain","Low Grade Glioma of Brain","Low Grade Gliomas",[95,96,93,97,98],"Patient Reported Outcomes","glioma","grade 2 glioma","IDH mutant","2026-04-17",{"date":101,"type":38},"2026-04-23",{"date":103,"type":38},"2025-04-23",{"date":105,"type":21},"2027-10",{"name":107,"class":45},"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":77},"100465767","phase-2-all-trans-retinoic-acid-atra-plus-pd-1-inhibition-in-recurrent-idh-mutant-glioma-100465767","NCT05345002","All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma","A Phase 2 Trial of All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma","Inclusion Criteria:\n\n1. Prior histopathologically proven diagnosis of astrocytoma (grade 2-4) or oligodendroglioma (grade 2-3) according to the World Health Organization (WHO) 2021 Classification System that is progressive or recurrent following at least one prior alkylating chemotherapy regimen (i.e., temozolomide and\u002For lomustine), +\u002F- radiation therapy\n2. Patient's tumor must have a known mutation in IDH1 or IDH2. IDH1\u002F2 mutation status must be confirmed by DNA sequencing and could have been performed in any CLIA\u002FCAP-certified laboratory. IDH1\u002F2 mutational testing could have been performed on patient's tumor either at initial diagnosis or on a subsequent recurrent tumor.\n3. Safety Run-In and Phase 2 (Arm A and Arm B) patients:\n\n   * All Safety Run-In and Phase 2 patients: patients with any contrast-enhancing tumor must have measurable disease per RANO criteria (defined by at least 1cmx1cm of contrast-enhancing tumor). Patients with exclusively non-enhancing tumors must have least a 25% increase in bi-dimensional product of FLAIR signal abnormality (measurable disease) compared to the patient's best MRI scan (smallest bi-dimensional product of FLAIR signal abnormality) obtained following completion of the patient's most recent line of therapy\n   * Safety Run-In: Must have failed temozolomide OR another alkylator (e.g. lomustine, procarbazine, carmustine). May have failed an unlimited number of prior systemic regimens, +\u002F- prior radiotherapy.\n   * Arm A: Must have failed temozolomide AND another alkylator (e.g. lomustine, procarbazine, carmustine). May have failed an unlimited number of prior systemic regimens, +\u002F- prior radiotherapy.\n   * Arm B: Must have failed temozolomide OR another alkylator (maximum one prior chemotherapy regimen) +\u002F- prior radiotherapy, AND must have gone at least 12 months since last treatment (chemotherapy or radiotherapy).\n4. Surgical patients (Arm C and Arm D):\n\n   * Must have clinical indication for surgical resection of the suspected recurrent\u002Fprogressive tumor, as determined by patient's care providers; measurable disease is not required\n   * 5-aminolevulinic acid (5-ALA) is not allowed for intraoperative tumor visualization due to the photosensitizing agent interaction with ATRA\n   * Patient may have had an unlimited number of relapses and prior therapy regimens\n5. Patients must be able to undergo MRI of the brain with gadolinium. Patients must be maintained on a stable or decreased dose of corticosteroid regimen (no increase for 5 days) prior to this baseline MRI.\n6. Patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:\n\n   * 12 weeks from completion of radiation\n   * 6 weeks from a nitrosourea cytotoxic chemotherapy\n   * 3 weeks from a non-nitrosourea cytotoxic chemotherapy\n   * 4 weeks from any investigational (not Food and Drug Administration \\[FDA\\]-approved) agents, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter\n   * 2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g. abemaciclib, olaparib, etc)\n7. If patient is on systemic corticosteroids to treat brain edema and\u002For brain edema-related symptoms, the dose must be 2mg of dexamethasone (or equivalent) daily or less for a minimum of 5 days prior to first dose of retifanlimab.\n8. Patients must be able to swallow oral medications\n9. Age 18 or older\n10. Karnofsky performance status greater than or equal to 60\n11. Life expectancy \\>3 months\n12. Adequate organ and marrow function:\n\n    * Total bilirubin \\\u003C1.5 x upper limit of normal (ULN) (except patients with suspected Gilbert's Syndrome, who are eligible for the study but exempt from the total bilirubin eligibility criterion)\n    * ALT and AST ≤ 2.5x ULN\n    * Calculated CrCl ≥ 30 ml\u002Fmin (glomerular filtration rate can also be used in place of CrCl)\n    * Absolute Neutrophil count ≥1,500\u002FuL\n    * Platelets ≥ 100,000\u002FuL\n    * Hemoglobin ≥ 9 g\u002FdL\n13. Reproductive Status\n\n    1. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 7 days prior to the start of study drug.\n    2. b) Women must agree to not breastfeed during the study or for 180 days after the last dose of study treatment\n    3. WOCBP must agree to use an adequate method to avoid pregnancy (as defined below) from the time of study screening through 180 days from last dose of study drug\n    4. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception (as defined below) starting with the first dose of study drug through 180 days after the last dose of study\n    5. Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, these WOCBP must still undergo pregnancy testing as described in this section.\n\n    At a minimum, participants of childbearing potential who are sexually active and their partners must agree to the use of a highly effective form of contraception (as defined below) throughout their participation beginning with the time of consent, during the study treatment, and for 180 days after last dose of study treatment(s).\n\n    HIGHLY EFFECTIVE METHODS OF CONTRACEPTION:\n    * Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants and intrauterine devices (IUDs) by WOCBP subject or male subject's WOCBP partner. Female partners of male subjects participating in the study may use hormone-based contraceptives as one of the acceptable methods of contraception since they will not be receiving study drug\n    * Nonhormonal IUDs\n    * Bilateral Tubal ligation\n    * Vasectomy\n    * Sexual Abstinence\n\n      * It is not necessary to use any other method of contraception when complete abstinence is elected.\n      * WOCBP participants who choose complete abstinence must continue to have pregnancy tests.\n      * Acceptable alternate methods of highly effective contraception must be discussed in the event that the WOCBP participants chooses to forego complete abstinence.\n14. Participant must, in the opinion of the Investigator, be able to comply with study procedures\n15. Patients must be able to understand the study procedures and agree to participate in the study by providing written informed consent (or have legally authorized representative sign on patient's behalf if patient physically unable to sign consent due to neurologic deficit)\n\nExclusion Criteria:\n\nAny of the following would exclude the subject from participation in the study:\n\n1. Contrast-enhancing tumor in brainstem or spinal cord (subjects do not need spinal MRI for screening, but known spinal cord tumor is exclusionary)\n2. Diffuse leptomeningeal disease\n3. Patients who have received bevacizumab within the last 3 months are ineligible\n4. Patients with clinically significant mass effect or midline shift (e.g., 1-2 cm of midline shift)\n5. Use of any immunosuppressive medication other than steroids, including but not limited to antimetabolites, calcineurin inhibitors, and\u002For anti-TNF agents within six months of start of study drug\n6. Prior diagnosis of immunodeficiency\n7. Prior solid organ or bone marrow transplantation\n8. Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\\> 10 mg\u002Fday of prednisone or equivalent).\n\n   * Physiologic corticosteroid replacement therapy at doses ≤ 10 mg\u002Fday of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.\n   * Participants with asthma that requires intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections may participate.\n   * Participants using topical, ocular, intra-articular, or intranasal corticosteroids (with minimal systemic absorption) may participate.\n   * Brief courses of corticosteroids for prophylaxis (eg, contrast dye allergy) or study treatment-related standard premedications are permitted.\n\n   EXCEPTIONS: Patients with the following autoimmune diseases may participate: type I diabetes mellitus, hypothyroidism only requiring hormone replacement, Grave's disease that is previously treated with thyroidectomy or radioiodine, celiac disease with symptoms controlled with a gluten-free diet.\n9. Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis.\n10. Immune related toxicity during prior checkpoint inhibitor therapy for which permanent discontinuation of therapy was recommended (per product label or consensus guidelines) or any immune-related toxicity requiring intensive or prolonged immunosuppression to manage (with the exception of endocrinopathy that is well controlled on replacement hormones).\n11. Known active hepatitis B virus (HBsAg reactive) or active hepatitis C virus (HCV RNA detectable by PCR)\n12. Human immunodeficiency virus (HIV)-positive patients on antiretroviral therapy\n13. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are excluded from this trial. Otherwise, patients with prior or concurrent malignancy are eligible.\n14. Any serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection that, in the opinion of the investigator, would put the subject at undue risk from the study treatment.\n15. Patients with uncontrolled or significant cardiovascular disease including, but not limited to, any of the following are ineligible:\n\n    * Myocardial infarction or uncontrolled angina within 90 days prior to consent\n    * History of clinically significant arrhythmia (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes)\n    * History of cardiomyopathy, pericarditis, significant pericardial effusion, myocarditis, or New York Heart Association (NYHA) functional class III-IV congestive heart failure\n16. Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (e.g., antihistamines and corticosteroids)\n17. Known allergy or hypersensitivity to any component of retifanlimab or formulation components.\n18. Known allergy or hypersensitivity to all-trans retinoic acid (tretinoin), any of its components, or other retinoids\n19. Prisoners or subjects who are involuntarily incarcerated\n20. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness\n21. Pregnant women are excluded\n22. Has received a live vaccine within 28 days before the planned start of study treatment\n\n    Note: Examples of live vaccines include but are not limited to measles, mumps, rubella, varicella-zoster (chickenpox), yellow fever, rabies, BCG, and typhoid vaccines. Seasonal influenza vaccines for injection are generally killed-virus vaccines and are allowed; however, intranasal influenza vaccines are live, attenuated vaccines and are not allowed.\n23. Participant must not be simultaneously enrolled in any interventional clinical trial",{"count":116,"type":21},55,[24],"This is a Phase II study of the combination of All-Trans Retinonic Acid (ATRA) and PD-1 inhibition (Retifanlimab) in patient with recurrent IDH-mutant glioma. The Sponsor-Investigator hypothesizes that the proposed regimen will be safe and stimulate a robust anti-tumor immune response.",[90,28,120,121],"Astrocytoma","Oligodendroglioma","2026-02-19",{"date":124,"type":38},"2026-02-20",{"date":126,"type":38},"2022-11-16",{"date":128,"type":21},"2028-06-01",{"name":130,"class":45},"Stephen Bagley, MD, MSCE",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":139,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":77},"100380453","metabolic-characterization-of-space-occupying-lesions-of-the-brain-100380453","NCT04233788","Metabolic Characterization of Space Occupying Lesions of the Brain","Metabolic Characterization of Space Occupying Lesions of the Brain Using in Vivo MR- (Spectroscopic) Imaging at 3 Tesla and 7 Tesla","FASTMRSI","Inclusion Criteria:\n\n* Healthy people who are able to lie in the MR scanner for one hour;\n* Patients with suspected mass in the brain\n* Written informed consent\n\nExclusion Criteria:\n\n* Persons under the age of 18\n* Persons who are mentally unable to choose to participate\n* Pregnant women\n* Patients with oncological findings or neurodegenerative findings in the past\n* Wearing active implants (e.g. pacemakers and neurostimulators)\n* Emergency patients\n* Persons with tattoos on the head or neck area",true,{"count":116,"type":21},"High field MR-technologies are expected to boost metabolic spectroscopic imaging (MRSI), but also CEST-MRI. This is due to the fact that increased SNR is available which can be used to increase the spatial resolution of all sequences, or reduction of measurement times. Recent findings has shown that MRSI can be used to evaluate the isocitrate dehydrogenase (IDH) status of gliomas, a brain tumor type which is most often diagnosed in humans. Patients with IDH-mutated gliomas have a much longer survival time that IDH-wildtype. In IDH-mutated gliomas the substance 2-hydroxy-glutarate (2HG) is found, whereas in IDH-wildtype gliomas it is not.\n\nThe underlying trial aims to measure 2HG directly with different MRSI sequences at 3 Tesla (3T) and 7 Tesla (7T) magnetic field strength. Apart from MRSI-techniques for IDH-typing it has been shown that CEST-imaging can also be performed to determine the IDH-status of gliomas.\n\nA total of 75 patients and 50 healthy controls will be examined in this study to evaluate the most accurate method for pre-operative IDH-status determination.",[143,90,28],"Brain Tumor",[145,146,147,148,149,150],"Magnetic Resonance Spectroscopic Imaging (MRSI)","Chemical exchange saturation transfer imaging (CEST)","Pulse sequence development","Preoperative prediction of IDH-status","Quantitative MR(S)I","Signal processing","2024-11-20",{"date":153,"type":38},"2024-11-25",{"date":155,"type":38},"2021-09-01",{"date":157,"type":21},"2025-12-31",{"name":159,"class":45},"Insel Gruppe AG, University Hospital Bern"]