NCT06942104

Imaging of Solid Tumors Using 18F-TRX

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Rahul Aggarwal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

PRIMARY OBJECTIVE: I. To determine the safety of fluorine F 18 trioxolane (18F-TRX) in participants with any solid tumor malignancy with at least 3 metastatic lesions on conventional imaging (Cohort 1); or known or presumed high grade glioma, locally advanced metastatic clear cell renal cell carcinoma with at least 3 lesions on conventional imaging, and metastatic castration-resistant prostate cancer (mCRPC) with at least 1 metastatic lesion on conventional imaging (Cohort 2). SECONDARY OBJECTIVES: I. To determine the organ dosimetry and pharmacokinetics of 18F-TRX (Cohort 1). II. To determine the sensitivity for detection of malignant lesions with 18F-TRX PET in participants with metastatic castration-resistant prostate cancer (n = 30), locally advanced or metastatic clear cell renal cell carcinoma (n = 10), and World Health Organization (WHO) grade 3 or 4 glioma (n = 10) (Cohort 2). III. To determine the feasibility of lesion detection using 18F-TRX in participants with known or presumed high grade glioma, locally advanced metastatic clear cell renal cell carcinoma with at least 3 lesions on conventional imaging, and mCRPC with at least 1 metastatic lesion on conventional imaging (Cohort 2). EXPLORATORY OBJECTIVE: I. To correlate 18F-TRX uptake with Six-Transmembrane Epithelial Antigen of Prostate 3 (STEAP3) expression determined by immunohistochemistry (IHC) evaluation of tumor tissue obtained within 3 months of PET. OUTLINE: Participants are assigned to 1 of 2 cohorts: COHORT 1: Participants receive 18F-TRX intravenously (IV) and undergo up to 8 PET/CT or PET/MRI scans. COHORT 2: Participants receive 18F-TRX IV and undergo a single scan. After completion of study intervention, patients are followed up 1-7 days post-injection.

Conditions

• Solid Tumor
• Solid Carcinoma
• Castration-Resistant Prostate Carcinoma
• Locally Advanced Clear Cell Renal Cell Carcinoma
• Metastatic Clear Cell Renal Cell Carcinoma
• Metastatic Malignant Solid Neoplasm
• Stage III Renal Cell Cancer AJCC v8
• Stage IV Renal Cell Cancer AJCC v8
• Stage IVB Prostate Cancer AJCC v8
• Glioma, Malignant

Interventions

Type	Name	Description
DRUG	18F-TRX	Given Intravenously (IV)
PROCEDURE	Positron Emission Tomography (PET)/Computerized tomography (CT)	Imaging procedure
PROCEDURE	Tumor Biopsy	May undergo tumor biopsy
PROCEDURE	Blood Specimen Collection	Undergo blood sample collection

Timeline

• Start date: 2025-07-03
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2025-04-24
• Last updated: 2025-07-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study