NCT06942104 Imaging of Solid Tumors Using 18F-TRX
| NCT ID | NCT06942104 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Rahul Aggarwal |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2025-07-03 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 56 participants in total. It began in 2025-07-03 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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/CT or PET/MRI, may help detect tumors in patients with solid tumors
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * Advanced solid tumor malignancy in one of the following cohorts: * Cohort 1 (n = 6): Any solid tumor malignancy with at least 3 metastatic lesions on conventional imaging * Cohort 2 (n = 50): * WHO grade 3 or 4 glioma - patients with known (by integrated molecular and histopathologic diagnosis) or presumed (by imaging; e.g., enhancing necrotic and/or 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). * 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). * Ability to understand and the willingness to sign a written informed consent document. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Negative serum or urine pregnancy test (women of childbearing potential only) within 72 hours of baseline procedures. * Absolute neutrophil count \> 1.5 x 10\^6/L. * Platelets \> 75,000 x 10\^6/L. * Hemoglobin \> 8 g/dL. * Total bilirubin \< 1.5 x upper limit of normal. * Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase (SGOT)) \< 2.5 x upper limit of normal (\< 5 x upper limit of normal in patients with liver metastases on conventional imaging). * Alanine aminotransferase (ALT)(serum glutamic-pyruvic transaminase (SGPT)) \< 2.5 x upper limit of normal (\< 5 x upper limit of normal in patients with liver metastases on conventional imaging). * Creatinine clearance \> 50 ml/min, calculated using the Cockcroft-Gault equation. Exclusion Criteria: * 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. * Individuals receiving strong inhibitors or inducers of CYP3A4. * Uncontrolled active infection or other medical condition that would preclude safe participation in the study as judged by the Investigator. * Individuals who are pregnant. * 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. * 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/or bilateral oophorectomy for removal of uterus and/or ovaries). * Individuals who are breastfeeding/chestfeeding. * Breastfeeding/chestfeeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn/nursing child secondary to administration of 18F-TRX to the study participant. * Breastfeeding/chestfeeding should be discontinued before administration of 18F-TRX.
Contact & Investigator
Rahul Aggarwal, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06942104 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06942104 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06942104 currently recruiting?
Yes, NCT06942104 is actively recruiting participants. Contact the research team at Maya.Aslam@ucsf.edu for enrollment information.
Where is the NCT06942104 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT06942104 clinical trial?
NCT06942104 is sponsored by Rahul Aggarwal. The principal investigator is Rahul Aggarwal, MD at University of California, San Francisco. The trial plans to enroll 56 participants.