About this trial
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
Qualifiers
Age ≥ 18 years
Cohort 1 (n = 6): Any solid tumor malignancy with at least 3 metastatic lesions on conventional imaging
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- 18F-TRX
- Positron Emission Tomography (PET)/Computerized tomography (CT)
- Tumor Biopsy
- Blood Specimen Collection
Treatment groups
Sponsors and collaborators
Rahul Aggarwal
Lead sponsor
University of California, San Francisco
Sponsor institution
United States Department of Defense
Collaborator