Imaging of Solid Tumors Using 18F-TRX
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
• 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.