[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Rahul Aggarwal\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":81},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"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":25,"conditions":26,"keywords":33,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100507526","phase-1-64cu-grip-b-in-patients-with-advanced-malignancies-100507526",false,"NCT05888532","64Cu-GRIP B in Patients With Advanced Malignancies","A First-in-Human, Phase I\u002FII PET Imaging Study of 64Cu-GRIP B, a Radiotracer Targeting Granzyme B, in Patients With Advanced Malignancies","Inclusion Criteria:\n\n1. Disease characteristics by cohort, as defined by:\n\n   Cohort A:\n   * Histologically-confirmed metastatic solid tumor malignancy (3 Male, 3 Female)\n   * Locally advanced or metastatic disease on conventional imaging\n\n   Cohort B:\n   * Histologically-confirmed metastatic renal cell carcinoma (any histologic sub-type) or urothelial carcinoma\n   * Locally advanced or metastatic disease on conventional imaging\n\n   Cohort C:\n   * Histologically-confirmed prostate adenocarcinoma\n   * Metastatic castration resistant prostate cancer by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria\n2. Planned treatment with immune checkpoint inhibitor (Cohorts B and C only)\n3. Willing to undergo paired tumor biopsies and has safely accessible bone or soft tissue lesion (Cohorts B and C only)\n4. The subject is able and willing to comply with study procedures and provide signed and dated informed consent.\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n6. Age 18 years or older at the time of study entry.\n7. Adequate organ function, as defined by:\n\n   * Serum creatinine \\\u003C= 1.5 x upper limit of normal (ULN) or estimated creatinine clearance \\> 60 mL\u002Fmin\n   * Total bilirubin \\\u003C= 1.5 x ULN (\\\u003C 3 x ULN in patients with documented or suspected Gilbert's).\n   * Hemoglobin \\>= 8.0 g\u002FdL\n   * Platelet count \\>= 75,000\u002Fmicroliter\n   * Absolute neutrophil count ≥ 1000\u002Fmicroliter\n8. Patients must not be pregnant or breast feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of PET Imaging scan. Effective contraception (men and women) must be used in subjects of child-bearing potential.\n\nExclusion Criteria:\n\n1. Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.\n2. Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.\n3. Is currently pregnant or breastfeeding.","ALL","18 Years",{"count":19,"type":20},91,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This phase I\u002FII clinical trial evaluates if using a radiotracer targeting granzyme B, 64-copper granzyme targeting restricted interaction peptide specific to family member B (64 Cu-GRIP B) with positron emission tomography (PET) imaging can be safe and useful for detecting granzyme B (GrB) in patients with advanced cancers that has spread to nearby tissue or lymph nodes (advanced). Granzyme B (GrB) is a biomarker produced by immune cells in response to immunotherapy, which may highlight tumors that are more likely to respond to treatment. The study population is focused on genitourinary (GU) malignancies, including renal cell and urothelial cancer, two tumor types with high mutational burden and tumor infiltrating lymphocytes compared to other tumor types, and have a predictable response rate at the population level to immune checkpoint inhibitors. The information gained from this trial may allow researchers to develop future trials where 64Cu-GRIP B PET may serve as a biomarker to monitor early response to immunomodulatory therapies which are used to stimulate or suppress the immune system and may help the body fight cancer.",[27,28,29,30,31,32],"Prostate Cancer","Renal Cancer","Urethral Cancer","Advanced Solid Tumor","Metastatic Castration-resistant Prostate Cancer","Solid Tumor, Adult",[34,35,36],"Imaging Study","Radiotracer","Granzyme B","RECRUITING","2026-03-13",{"date":40,"type":41},"2026-03-17","ACTUAL",{"date":43,"type":41},"2023-05-25",{"date":45,"type":20},"2027-01-31",{"name":47,"class":48},"Rahul Aggarwal","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":71,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":49},"100588492","phase-1-imaging-of-solid-tumors-using-18f-trx-100588492","NCT06942104","Imaging of Solid Tumors Using 18F-TRX","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Advanced solid tumor malignancy in one of the following cohorts:\n\n  * Cohort 1 (n = 6): Any solid tumor malignancy with at least 3 metastatic lesions on conventional imaging\n  * Cohort 2 (n = 50):\n\n    * WHO grade 3 or 4 glioma - patients with known (by integrated molecular and histopathologic diagnosis) or presumed (by imaging; e.g., enhancing necrotic and\u002For hypervascular intrinsic brain tumor) high grade (WHO grade 3 or 4) glioma (n = 10), Locally advanced or metastatic clear cell renal cell carcinoma with at least three metastatic lesions on conventional imaging (n = 10).\n    * Metastatic castration-resistant prostate cancer with at least one metastatic lesion on conventional imaging including cross-sectional imaging of the chest, abdomen and pelvis and whole body bone scan or prostate-specific membrane antigen (PSMA) PET scan (n = 30).\n* Ability to understand and the willingness to sign a written informed consent document.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Negative serum or urine pregnancy test (women of childbearing potential only) within 72 hours of baseline procedures.\n* Absolute neutrophil count \\> 1.5 x 10\\^6\u002FL.\n* Platelets \\> 75,000 x 10\\^6\u002FL.\n* Hemoglobin \\> 8 g\u002FdL.\n* Total bilirubin \\\u003C 1.5 x upper limit of normal.\n* Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase (SGOT)) \\\u003C 2.5 x upper limit of normal (\\\u003C 5 x upper limit of normal in patients with liver metastases on conventional imaging).\n* Alanine aminotransferase (ALT)(serum glutamic-pyruvic transaminase (SGPT)) \\\u003C 2.5 x upper limit of normal (\\\u003C 5 x upper limit of normal in patients with liver metastases on conventional imaging).\n* Creatinine clearance \\> 50 ml\u002Fmin, calculated using the Cockcroft-Gault equation.\n\nExclusion Criteria:\n\n* 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.\n* Individuals receiving strong inhibitors or inducers of CYP3A4.\n* Uncontrolled active infection or other medical condition that would preclude safe participation in the study as judged by the Investigator.\n* Individuals who are pregnant.\n\n  * Individuals of childbearing potential (defined below) must agree to undergo a urine pregnancy test prior to participating in the study scans. Pregnant individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn child secondary to administration of 18F-TRX to the study participant.\n  * A female is considered to not be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if the participant 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 breastfeeding\u002Fchestfeeding.\n\n  * Breastfeeding\u002Fchestfeeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn\u002Fnursing child secondary to administration of 18F-TRX to the study participant.\n  * Breastfeeding\u002Fchestfeeding should be discontinued before administration of 18F-TRX.",{"count":57,"type":20},56,[23],"This phase I trial tests the safety and effectiveness of 18F-TRX in detecting tumors (cancer) patients with solid tumors. 18F-TRX is an imaging tracer that is used to visualize tumors using a PET scan. It specifically targets and detects labile (unstable) iron levels within tissues, including tumors. Diagnostic procedures, such as 18F-TRX PET\u002FCT or PET\u002FMRI, may help detect tumors in patients with solid tumors",[61,62,63,64,65,66,67,68,69,70],"Solid Tumor","Solid Carcinoma","Castration-Resistant Prostate Carcinoma","Locally Advanced Clear Cell Renal Cell Carcinoma","Metastatic Clear Cell Renal Cell Carcinoma","Metastatic Malignant Solid Neoplasm","Stage III Renal Cell Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Stage IVB Prostate Cancer AJCC v8","Glioma, Malignant",[72],"Imaging Studies","2025-07-17",{"date":75,"type":41},"2025-07-18",{"date":77,"type":41},"2025-07-03",{"date":79,"type":20},"2026-09-30",{"name":47,"class":48},""]