Phase 1 Study of 18F-TRX Imaging to Detect and Evaluate Solid Tumors Including Glioma, Renal Cell Carcinoma, and Prostate Cancer

What this Trial Is About

Researchers are evaluating 18F-TRX, a new imaging tracer, in patients with solid tumors to test its safety and ability to detect cancerous lesions. This phase I trial focuses on patients with solid tumor malignancies having multiple metastatic lesions or specific high-grade tumors, including glioma, clear cell renal cell carcinoma, and metastatic castration-resistant prostate cancer. The goal is to understand how well 18F-TRX works in visualizing tumors and to assess any treatment-related side effects. Participants receive the 18F-TRX tracer intravenously and undergo positron emission tomography PET combined with computerized tomography CT or magnetic resonance imaging MRI. There are two cohorts Cohort 1 involves patients with any solid tumor malignancy and at least three metastatic lesions who receive up to eight PET scans lasting about 220 minutes each. Cohort 2 includes patients with specific high-grade tumors who receive a single PET scan lasting between 55 and 144 minutes. Some participants may have blood samples collected and may undergo tumor biopsies during screening. During the study, participants are monitored for side effects up to seven days after injection. Researchers measure the safety of 18F-TRX, how the tracer distributes in the body, and its sensitivity in detecting tumors. Additional assessments include comparing 18F-TRX imaging to conventional methods and correlating tracer uptake with tumor tissue markers. Follow-up occurs within one to seven days post-injection, with total study participation depending on the cohort and procedures involved.

Imaging of Solid Tumors Using 18F-TRX