Imaging of Solid Tumors Using 18F-TRX

Part of paid clinical trials in San Francisco, California.

Sponsor
Rahul Aggarwal
Study ID
NCT06942104
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Jul 3, 2025
Status verified
Jul 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
56 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • 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

Primary Outcome Measure

Proportion of participants with treatment-emergent adverse events [ Time Frame: Up to 7 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Maya Aslam
[email protected]
415-514-8987
[email protected]
877-827-3222
Spencer Behr, MD (PRINCIPAL_INVESTIGATOR)
Rahul Aggarwal, MD (PRINCIPAL_INVESTIGATOR)

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By research site
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