Actively Recruiting
Imaging of Solid Tumors Using 18F-TRX for Tumor Detection with PET Scans
Led by Rahul Aggarwal · Updated on 2025-07-18
56
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Rahul Aggarwal
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of 18F-TRX, an imaging tracer, in detecting tumors in patients with solid tumors. This phase I trial focuses on patients with metastatic solid tumors, including those with high-grade glioma, clear cell renal cell carcinoma, and metastatic castration-resistant prostate cancer. The tracer targets unstable iron levels in tissues to help visualize tumors using PET scans. This study aims to assess safety, organ dosimetry, pharmacokinetics, and detection sensitivity of 18F-TRX. Participants are assigned to one of two groups. Cohort 1 includes patients with any solid tumor and at least three metastatic lesions, who receive 18F-TRX intravenously and undergo up to eight PET/CT or PET/MRI scans lasting up to 220 minutes. Cohort 2 includes patients with specific cancers and metastatic lesions, who receive a single 18F-TRX injection followed by one scan lasting 55 to 144 minutes. Some participants may have tumor biopsies and blood samples collected during screening. Participants are monitored for treatment-related adverse events up to seven days after injection. Researchers collect imaging data to measure tumor detection sensitivity and organ radiation doses. Blood samples and tumor tissue are analyzed to explore tracer uptake correlation with tumor markers. Follow-up occurs between 1 and 7 days post-injection. The study tracks participants' safety and imaging results throughout their involvement, which varies by cohort.
CONDITIONS
Brief Title
Imaging of Solid Tumors Using 18F-TRX
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Advanced solid tumor malignancy with specific cohort criteria:
- Cohort 1: Any solid tumor with at least 3 metastatic lesions on imaging
- Cohort 2: WHO grade 3 or 4 glioma, or locally advanced/metastatic clear cell renal cell carcinoma with at least 3 metastatic lesions, or metastatic castration-resistant prostate cancer with at least 1 metastatic lesion on imaging
- Ability to understand and sign informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Negative pregnancy test for women of childbearing potential within 72 hours before baseline
- Adequate blood counts and organ function as specified (neutrophils, platelets, hemoglobin, bilirubin, liver enzymes, creatinine clearance)
You will not qualify if you...
- Any condition or circumstance that would impair ability to follow study procedures
- Use of strong CYP3A4 inhibitors or inducers
- Uncontrolled active infection or other medical condition that precludes safe participation
- Pregnancy
- Breastfeeding or chestfeeding
- Women of childbearing potential who do not agree to pregnancy testing or who are pregnant
- Participants who have not reached postmenopausal state or surgical sterilization if applicable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person) where blood samples may be collected and tumor biopsy may occur
Duration - Same day as injection for Cohort 2; multiple scans for Cohort 1 up to the day of last scan
Participants receive 18F-TRX intravenously and undergo PET scans to detect tumor lesions.
Cohort 1: Up to 8 PET/CT or PET/MRI scans in-person; Cohort 2: 1 PET scan (in-person)
Duration - 1 to 7 days post-injection
Participants are monitored for safety and adverse events following injection of 18F-TRX.
1 follow-up visit (in-person or remote) within 7 days after injection
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
M
Maya Aslam
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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