Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06942104

Imaging of Solid Tumors Using 18F-TRX

Led by Rahul Aggarwal · Updated on 2025-07-18

56

Participants Needed

1

Research Sites

64 weeks

Total Duration

On this page

Sponsors

R

Rahul Aggarwal

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Imaging of Solid Tumors Using 18F-TRX

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Advanced solid tumor malignancy meeting one of the following:
    • Cohort 1: Any solid tumor with at least 3 metastatic lesions on conventional imaging
    • Cohort 2: WHO grade 3 or 4 glioma; locally advanced or metastatic clear cell renal cell carcinoma with at least 3 metastatic lesions; metastatic castration-resistant prostate cancer with at least 1 metastatic lesion on imaging
  • Ability to understand and willing to sign informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Negative pregnancy test within 72 hours of baseline procedures for women of childbearing potential
  • Absolute neutrophil count greater than 1.5 x 10^6/L
  • Platelets greater than 75,000 x 10^6/L
  • Hemoglobin greater than 8 g/dL
  • Total bilirubin less than 1.5 times the upper limit of normal
  • AST (SGOT) less than 2.5 times upper limit of normal (less than 5 times if liver metastases present)
  • ALT (SGPT) less than 2.5 times upper limit of normal (less than 5 times if liver metastases present)
  • Creatinine clearance greater than 50 ml/min calculated by Cockcroft-Gault equation
Not Eligible

You will not qualify if you...

  • Any condition or social circumstance that would impair ability to comply with study procedures
  • Use of strong inhibitors or inducers of CYP3A4
  • Uncontrolled active infection or other medical conditions that would prevent safe participation
  • Pregnant individuals
  • Breastfeeding or chestfeeding individuals
  • Women of childbearing potential must have a negative pregnancy test before scans
  • Females considered not of childbearing potential if postmenopausal for at least 12 months or surgically sterilized (hysterectomy and/or bilateral oophorectomy)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California, San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

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Research Team

M

Maya Aslam

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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