[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nerve-sheath-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nerve-sheath-tumor":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"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":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":65,"conditions":66,"keywords":67,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":52},"100558611","phase-2-phase-ii-study-of-fcn-159-in-nf2-nerve-sheath-tumors-100558611","NCT06553365","Phase II Study of FCN-159 in NF2 Nerve Sheath Tumors","An Open, Single-Arm Phase II Study Evaluating the Efficacy and Safety of FCN-159 in Selected NF2-associated Nerve Sheath Tumors","Inclusion Criteria:\n\n1. ≥16 years of age, regardless of gender.\n2. meet the revised 2022 diagnostic criteria for NF2-associated nerve sheath tumors or pathologically confirmed NF2-associated nerve sheath tumors.\n3. should meet one of the following criteria: 1) Incomplete surgical resection, or postoperative recurrence. 2) Systemic therapy is required as determined by the Investigator.\n4. the presence of a measurable lesion, as defined by REiNS or RECIST V1.1 criteria.\n5. Karnofsky physical status score of ≥70.\n6. the patient has adequate organ and bone marrow function.\n7. International Normalized Ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN.\n8. For patients of childbearing potential: During treatment and for at least 90 days after the last dose, patients should agree to use a highly effective method of contraception.\n9. avoid excessive sun exposure and be willing to use an adequate amount of sunscreen in anticipation of sun exposure.\n10. be able to understand and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n* Previously received one of the following treatments:\n\n  1. Pharmaceutical or biological therapy within 3 weeks or 5 half-lives prior to enrollment, whichever is longer.\n  2. Use of growth factors that promote platelet, red blood cell, or white blood cell count or function within 7 days prior to enrollment.\n  3. Patients who have received major surgery or anti-tumor immunotherapy within 4 weeks prior to enrollment.\n  4. Radiation therapy for nerve sheath tumors within 4 weeks prior to enrollment.\n  5. Dose adjustment for patients treated with dexamethasone or other corticosteroids within 1 week prior to enrollment.\n  6. Patients who have participated in another interventional clinical trial within 4 weeks prior to enrollment.\n  7. Prior treatment with Selumetinib or any other MEK 1\u002F2 inhibitor. 2. history of or concurrent with other malignancies. 3. inability to undergo MRI and\u002For contraindications to MRI. 4. uncontrolled hypertension. 5. the presence of dysphagia, active gastrointestinal disease, malabsorption syndrome, or other condition that interferes with the absorption of the study medication.\n\n     6\\. previous or current retinal vascular disease. 7. interstitial pneumonitis 8. cardiac function or co-morbidities 9. Immediate family history of sudden cardiac death before age 50. 10.History of any acute neurological condition 11. with active bacterial, fungal or viral infections 12. known hypersensitivity to the study drug, other MEK1\u002F2 inhibitors, or their excipients.","16 Years",{"count":62,"type":20},30,[64],"PHASE2","The goal of this clinical trial is to evaluate the efficacy and safety of FCN-159 in patients with specific NF2-associated nerve sheath tumors.",[27],[68,69,70],"MEK","NF2","nerve sheath tumor","RECRUITING","2025-07-25",{"date":74,"type":44},"2025-07-29",{"date":76,"type":44},"2024-08-15",{"date":78,"type":20},"2026-07-31",{"name":80,"class":51},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences"]