Imaging of Solid Tumors Using 18F-TRX

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 1
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Maya Aslam
Maya.Aslam@ucsf.edu
(415) 514-8987
Time Frame
Start Date: 2025-07-03
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 56
Treatments
Experimental: Cohort 1: Diagnostic (18F-TRX)
Participants with any solid tumor malignancy with at least 3 metastatic lesions on conventional imaging will receive multiple scans lasting 220 minutes after injection. Participants undergo blood sample collection and may undergo tumor biopsy during screening
Experimental: Cohort 2: Diagnostic (18F-TRX)
Participants with WHO grade 3 or 4 glioma, locally advanced or metastatic clear cell renal cell carcinoma with at least three metastatic lesions on conventional imaging, or 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) will receive a single scan lasting 55-144 minutes after injection. Participants may undergo tumor biopsy during screening
Sponsors
Collaborators: United States Department of Defense
Leads: Rahul Aggarwal

This content was sourced from clinicaltrials.gov