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
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).
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.
Parallel
18F-TRX
DrugGiven Intravenously (IV)
Positron Emission Tomography (PET)/Computerized tomography (CT)
Procedure/SurgeryImaging procedure
Tumor Biopsy
Procedure/SurgeryMay undergo tumor biopsy
Blood Specimen Collection
Procedure/SurgeryUndergo blood sample collection
Proportion of participants with treatment-emergent adverse events
The proportion of participants with any treatment-emergent adverse events will be reported by grade and frequency per the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. All participants who receive the radiotracer injection will be evaluable.
Median Target to Background Ratio (TBR) (Cohort 1)
The measured target-to-background ratios (TBRs) will be reported as the median and range similar to previously reported. The scan time point generating the highest mean TBR will be chosen for subsequent imaging in cohort 2.
Mean radiation-absorbed doses (Cohort 1)
The results from the scans for all patients enrolled will be combined to allow the calculation of mean, standard deviation (SD), and range of radiation-absorbed doses to individual organs as well as effective dose
Sensitivity of tumor lesion detection (Cohort 2)
Sensitivity is the probability that a test will indicate a lesion among those with disease: Sensitivity = True Positive / (True Positive + False Negative). The lesion is defined as positive if the short axis dimension of lymph nodes is greater than 1.5 cm, and organ metastases measure \> 1 cm in long axis by conventional imaging. The sensitivity will be obtained by point estimation and 95% confidence interval assuming all lesions are independent to determine the number of tru
Number of lesions detected by fludeoxyglucose F-18 (18F)-TRX positron emission tomography (PET) (Cohort 2)
Number of lesions detected by 18F-TRX PET, but not detected on conventional imaging.
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Rahul Aggarwal
Lead sponsor
University of California, San Francisco
Sponsor institution
United States Department of Defense
Collaborator
