[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nerve-sheath-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nerve-sheath-neoplasms":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,53,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":38,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100644129","phase-1-imaging-study-of-89zrdfo-ys5-for-cancer-detection-100644129",false,"NCT07664397","Imaging Study of [89Zr]DFO-YS5 for Cancer Detection","A Pilot PET Imaging Study of [89Zr]DFO-YS5 for Detection of Cancer in Patients With Various Malignancies","Inclusion Criteria:\n\n1. Histological or cytological confirmation of malignant peripheral nerve sheath tumor, bladder cancer, or solid tumor neoplasm.\n2. At least one soft tissue lesion measurable at 1 cm or greater in short axis measurement on cross sectional imaging such as Computerized tomography (CT), magnetic resonance imaging (MRI), or Positron Emission Tomography (PET)\u002FCT (scan imaging as documented in the medical record). Exception: For participants with localized bladder cancer (pre-cystectomy), lesions smaller than 1 centimeter (cm) are permitted, provided there is cystoscopic confirmation of a bladder mass.\n3. Clinically able to undergo PET-CT imaging or PET-MRI.\n4. Age ≥ 18 years.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky ≥ 50% (see Appendix 1).\n6. Adequate organ function as defined below:\n\n   * Total bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN) (unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits).\n   * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)): ≤ 3 x ULN.\n   * Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)): ≤ 3 x ULN.\n   * Estimated creatinine clearance: ≥ 60 mL\u002Fmin, calculated using the Cockcroft-Gault equation.\n7. Females of reproductive potential (defined below) must be willing to undergo a urine or serum pregnancy test (i.e., human chorionic gonadotropin test) within 72 hours before administration of \\[89Zr\\]DFO-YS5. A female is considered to NOT be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries). The result of the urine or serum pregnancy test must be negative in order to initiate the \\[89Zr\\]DFO-YS5 administration. If a urine pregnancy test is positive or equivocal, a confirmatory a serum pregnancy test is required. The individual must be excluded from participation if the serum pregnancy result is positive. Pregnant individuals are excluded from this study because there is an unknown but potential risk for adverse effects in the unborn child secondary to treatment of the study participant with \\[89Zr\\]DFO-YS5.\n8. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible.\n9. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Individuals with a contraindication to PET-CT imaging (e.g., severe claustrophobia) or PET-MRI (e.g., implanted devices, metallic objects, or other implants). Participants must be able to undergo either PET-CT or PET-MRI.\n2. Individuals who are pregnant or breastfeeding\u002Fchest-feeding. Pregnant and breastfeeding\u002Fchest-feeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn\u002Fnursing child secondary to treatment of the study participant with \\[89Zr\\]DFO-YS5. Females of childbearing potential must have a negative pregnancy test before administration of \\[89Zr\\]DFO-YS5, as outlined in inclusion criterion #7. Breastfeeding\u002Fchest-feeding should be discontinued before administration of \\[89Zr\\]DFO-YS5.\n3. Individuals who do not agree to follow the below contraception requirements:\n\n   Females of reproductive potential (defined below) must agree to use two forms of contraception, consisting of a barrier method (such as condoms) in combination with a secondary complementary method (such as hormonal, Intrauterine device (IUD), etc.), or strict abstinence, for the duration of study participation and for 1 month after administration of \\[89Zr\\]DFO-YS5. A female is considered to NOT be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries).\n4. Hypersensitivity to \\[89Zr\\]DFO-YS5 or any of its excipients.\n5. Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a single-center, pilot, PET-imaging study of the novel radiotracer 89Zirconium-89 DFO conjugated to the YS5 monoclonal antibody (\\[89Zr\\]DFO-YS5) in participants with nerve sheath tumor, bladder cancer, or advanced solid tumor neoplasms.",[26,27,28,29,30,31,32,33,34,35,36,37],"Bladder Cancer","Nerve Sheath Tumor","Nerve Sheath Tumors","Solid Tumor Malignancies","Solid Tumor Cancer","Solid Tumor Neoplasms","Advanced Solid Tumor","Bladder Neoplasm","Nerve Sheath Neoplasms","Nerve Sheath Tumor, Nos","Solid Tumor, Adult","Solid Carcinoma",[39],"Imaging Study","NOT_YET_RECRUITING","2026-06-17",{"date":43,"type":44},"2026-06-24","ACTUAL",{"date":46,"type":20},"2026-08-01",{"date":48,"type":20},"2029-09-30",{"name":50,"class":51},"Robert Flavell, MD, PhD","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":52},"100533160","surveillance-for-malignant-transformation-of-neurofibromatosis-type-1-nf1-related-peripheral-nerve-sheath-tumors-pnst-100533160","NCT06222203","Surveillance for Malignant Transformation of Neurofibromatosis Type 1 (NF1) Related Peripheral Nerve Sheath Tumors (PNST)","* INCLUSION CRITERIA:\n\nHigh-Risk and Low-Risk NF1 Cohorts\n\n* Age \\>= 3 years old\n* Participants with clinical or genetic diagnosis of NF1.\n* Participants with a diagnosis of mosaic or segmental NF1 are also eligible.\n* Individuals may have (High-Risk Cohort) or not have (Low-Risk Cohort) at least one of the following characteristics:\n\n  * Microdeletion or 844-848 missense variants or other variants associated with increased risk of malignant peripheral nervous sheath tumor (MPNST)\n  * Family history of MPNST \u002F atypical neurofibromatous neoplasm of unknown biologic potential (ANNUBP) \u002F atypical neurofibromas (ANF)\n  * Personal history of MPNST\u002FANNUBP\u002FANF or neurofibroma with CDKN2A loss\n  * Prior radiation therapy at any site\n  * Large plexiform neurofibroma (PN) burden (\\>= 350 mL)\n  * Presence \\>= 1 DNL at baseline\n* The ability of the individual, parent\u002Fguardian or Legally Authorized Representative (LAR) to understand and the willingness to sign a written consent document for participation.\n\nEXCLUSION CRITERIA:\n\nHigh-Risk and Low-Risk NF1 Cohorts\n\n\\- Inability or unwillingness to undergo MRI imaging\n\nINCLUSION CRITERIA:\n\nParent Cohort\n\n* Parent or guardian of pediatric individuals (8-17 years old) in High-Risk or Low-Risk Cohorts.\n* The ability of the parent\u002Fguardian or LAR to understand and the willingness to sign a written consent document for parent\u002Fguardian participation in this study.\n\nEXCLUSION CRITERIA:\n\nParent Cohort\n\n\\- None.","3 Years","120 Years",{"count":62,"type":20},225,"OBSERVATIONAL","Background:\n\nNeurofibromatosis type 1 (NF1) is a genetic disease that can cause many symptoms. About half of people with NF1 will develop benign (noncancerous) tumors along nerves in the skin, brain, and other parts of the body. Sometimes, though, these tumors can become cancerous. Researchers do not yet know how to predict which tumors will become cancerous.\n\nObjective:\n\nTo test a new method for predicting which benign NF1 tumors will become cancerous.\n\nEligibility:\n\nPeople aged 3 years and older with a clinical or genetic diagnosis of NF1.\n\nDesign:\n\n* Participants will be screened with a review of their medical history. All participants will have a baseline visit. They will have bood tests and imaging scans. They will have a physical exam. They will answer questions about their family history. Participants aged 8 years and older will take tests of their thinking skills and their emotional health.\n* Some participants may be asked to undergo more tests. These may include another type of imaging scan and a biopsy: A small sample of tissue may be removed from the tumor.\n* Participants will be divided into two groups: those believed to be at low risk and those believed to be at high risk of developing cancer.\n* Participants in the high-risk group will be asked to return for their next visit in 1 month to 3 years.\n* Participants in the low-risk group will be asked to return for their next visit in 6 months to 5 years.\n* Participants may also have follow-up visits by phone throughout the study. They will be in the study for 10 years.",[66,34],"Neurofibromatosis 1",[68,69,70,71,72,73,74,75],"NF1","atypical neurofibromas","Plexiform Neurofibromas","neurofibromas","PN","MPNST","malignant transformation","distinct nodular lesion","RECRUITING","2026-06-03",{"date":79,"type":44},"2026-06-04",{"date":81,"type":44},"2024-10-09",{"date":83,"type":20},"2035-12-31",{"name":85,"class":86},"National Cancer Institute (NCI)","NIH",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":93,"targetDuration":95,"studyType":63,"phases":4,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":5},"100412277","proton-therapy-research-infrastructure--protrait--neuro-oncology-100412277","NCT04648462","Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology","Inclusion Criteria:\n\n1. All brain tumors with a favorable prognosis (median survival \\> 10 year)\n2. Age ≥ 18 years\n3. ECOG performance status 0 - 1 \u002F Karnofsky performance status 80 - 100\n4. No - minimal neurocognitive impairment\n5. Dosimetrical gain of protontherapy relative to photontherapy (≥5% on supratentorial brain dose or hippocampi)\n6. Informed consent\n\nExclusion Criteria:\n\n1. Not eligible for chemotherapy\n2. Eligible for stereotactic radiotherapy",{"count":94,"type":20},1500,"5 Years","The first proton therapy treatments in the Netherlands have taken place in 2018. Due to the physical properties of protons, proton therapy has tremendous potential to reduce the radiation dose to the healthy, tumour-surrounding tissues. In turn, this leads to less radiation-induced complications, and a decrease in the formation of secondary tumours. The Netherlands has spearheaded the development of the model-based approach (MBA) for the selection of patients for proton therapy when applied to prevent radiation-induced complications. In MBA, a pre-treatment in-silico planning study is done, comparing proton and photon treatment plans in each individual patient, to determine (1) whether there is a significant difference in dose in the relevant organs at risk (ΔDose), and (2) whether this dose difference translates into an expected clinical benefit in terms of NormalTissue Complication Probabilities (ΔNTCP). To translate ΔDose into ΔNTCP, NTCP-models are used, which are prediction models describing the relation between dose parameters and the likelihood of radiation-induced complications. The Dutch Society for Radiotherapy and Oncology (NVRO) setup the selection criteria for proton therapy in 2015, taking into account toxicity and NTCP. However, NTCP-models can be affected by changes in the irradiation technique. Therefore, it is paramount to continuously update and validate these NTCP-models in subsequent patient cohorts treated with new techniques. In ProTRAIT, a Findable, Accessible, Interoperable and Reusable (FAIR)data infrastructure for both clinical and 3D image and 3D dose information has been developed and deployed for proton therapy in the Netherlands. It allows for a prospective, standardized, multi-centric data from all Dutch proton and a representative group of photon therapy patients.",[98,99,100,101,102,103,34,104,105,106,107,108],"Astrocytoma","Ependymoma","Ganglioglioma","Oligodendroglioma","Optic Nerve Glioma","Meningioma","Adenoma","Craniopharyngioma","Hemangiopericytoma","Germinoma","Neurilemmoma","2024-11-25",{"date":111,"type":44},"2024-11-26",{"date":113,"type":44},"2018-01-01",{"date":115,"type":20},"2035-01-01",{"name":117,"class":51},"Maastricht Radiation Oncology"]