[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Robert Flavell, MD, PhD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":101},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,53,76],{"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":17,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":52},"100507823","phase-1-imaging-study-of-89zrdfo-ys5-for-detecting-cd46-positive-malignancy-in-multiple-myeloma-100507823","NCT05892393","Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma","Pilot PET Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed multiple myeloma by International Myeloma Working Group (IMWG) diagnostic criteria\n* At least one positive myelomatous lesion found on 18F-FDG PET\u002FCT or PET\u002FMRI. A positive lesion is defined as uptake greater than liver on FDG PET, based on the Italian myeloma criteria for PET use (IMPeTUs) criteria\n* Age \\>= 18 years\n* Total bilirubin =\\\u003C 1.5 X institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) =\\\u003C 3 X ULN\n* Alanine aminotransferase (ALT) =\\\u003C 3 X ULN\n* Creatinine clearance \\>= 30 mL\u002Fmin, calculated using the Cockcroft-Gault equation or serum creatinine \\\u003C= 1.5x the institutional upper limit of normal.\n* Ability to understand a written informed consent document, and the willingness to sign it\n\nExclusion Criteria:\n\n* Any condition that, in the opinion of the principal investigator, would impair the participants' ability to comply with study procedures or interfere with the safety of the investigational regimen\n* Individuals who are pregnant or breastfeeding\u002Fchestfeeding.\n* \\- Breast-feeding\u002Fchest-feeding should be discontinued before administration of \\[89ZR\\]DFO-YS5.\n* Females of childbearing potential must have a negative urine or serum pregnancy test (i.e., human chorionic gonadotropin test) within 72 hours prior to administration of \\[89ZR\\]-DFO-YS5.\n* \\- If the urine pregnancy test is positive or equivocal, a confirmatory serum pregnancy test is required. In such cases, the individual must be excluded from participation if the serum pregnancy result is positive.\n* \\- A female is considered to be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), unless it is documented that the individual meets 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).\n* Individuals who are pregnant or breastfeeding\u002Fchestfeeding 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",{"count":61,"type":20},20,[23],"This phase I trial tests the safety of \\[89Zr\\]DFO-YS5 positron emission tomography (PET) imaging and how well it works to detect CD46 positive cancer cells in patients with multiple myeloma. \\[89Zr\\]DFO-YS5 is an imaging agent called a radiopharmaceutical tracer. A radiopharmaceutical tracer uses a small amount of radioactive material that is injected into a vein to help image different areas of the body. \\[89Zr\\]DFO-YS5 targets a specialized protein called CD46, which is in certain multiple myeloma cancer cells, and \\[89Zr\\]DFO-YS5 PET scans may improve detection of multiple myeloma.",[65,66],"Multiple Myeloma","Plasma Cell Myeloma","RECRUITING","2026-06-11",{"date":70,"type":44},"2026-06-15",{"date":72,"type":44},"2023-06-16",{"date":74,"type":20},"2026-09-01",{"name":50,"class":51},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":52},"100584852","phase-1-pet-89zrdfo-starpeg-in-solid-tumors-100584852","NCT06894745","PET [89Zr]DFO-starPEG in Solid Tumors","Positron Emission Tomography (PET) Imaging of the Enhanced Permeability and Retention (EPR) Effect With [89Zr]DFO-starPEG in Patients With Solid Tumors","Inclusion Criteria:\n\n1. Age \\>= 18 years.\n2. Histological or cytological confirmation of solid tumor malignancy.\n3. Any malignancy, with at least one soft tissue lesion measurable at 1 centimeter (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, OR at least 1 lesion which is positive (defined as greater than surrounding background) in the bones on standard of care cancer imaging PET exam.\n4. Clinically able to undergo PET\u002FCT imaging.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky ≥ 50%.\n6. Adequate organ function as defined below within 0-28 days before \\[89Zr\\]DFO-starPEG administration:\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)\u002F serum glutamic-oxaloacetic transaminase (SGOT) ≤ 3 x ULN.\n   * Alanine aminotransferase (ALT)\u002F serum glutamic-pyruvic transaminase (SGPT) ≤ 3 x ULN.\n   * Estimated creatinine clearance: ≥ 60 mL\u002Fmin, calculated using the Cockcroft-Gault equation or 24 hour urine collection.\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-starPEG. 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-starPEG administration. If a urine pregnancy test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, 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-starPEG.\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).\n2. Individuals who are pregnant or breastfeeding\u002Fchestfeeding. Pregnant and breastfeeding\u002Fchestfeeding 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-starPEG. Females of childbearing potential must have a negative pregnancy test before administration of \\[89Zr\\]DFO-starPEG, as outlined in inclusion criterion #7. Breastfeeding\u002Fchestfeeding should be discontinued before administration of \\[89Zr\\]DFO-starPEG.\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-starPEG.\n   * 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-starPEG 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.",{"count":84,"type":20},13,[23],"This is a first-in-human, pilot study of the novel PET-imaging radiotracer \\[89Zr\\]DFO-starPEG. The study is designed to obtain preliminary data to support future development of this agent as an imaging surrogate to visualize enhanced permeability and retention (EPR)-mediated tracer uptake before administration of EPR-based nanomedicines.",[88,37,89],"Solid Tumor","Soft Tissue Lesion",[91,92],"Dosimetry","Imaging","2026-06-03",{"date":95,"type":44},"2026-06-05",{"date":97,"type":44},"2025-06-02",{"date":99,"type":20},"2027-12-31",{"name":50,"class":51},""]