18F-TRX Imaging for Cancer

Overseen By Maya Aslam

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Rahul Aggarwal

Must not be taking: CYP3A4 inhibitors/inducers

Disqualifiers: Pregnancy, Breastfeeding, Uncontrolled infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new imaging tracer, 18F-TRX, to determine its safety and effectiveness in detecting tumors in patients with solid tumors. 18F-TRX highlights unstable iron levels in tissues, which can indicate tumors. Participants will undergo PET scans to visualize the tumors. Suitable candidates include patients with advanced solid tumors, such as glioma or prostate cancer, who have multiple metastatic lesions visible in standard imaging tests. As a Phase 1 trial, participants will be among the first to receive this new tracer, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it excludes those taking strong inhibitors or inducers of CYP3A4. It's best to discuss your medications with the trial team.

What prior data suggests that 18F-TRX is safe for use in imaging?

Research shows that 18F-TRX is a new substance used in PET scans to help detect tumors. While specific safety information for 18F-TRX is not yet available, similar substances with 18F have been tested in people and are generally safe, with few serious side effects.

As a phase 1 trial, the primary goal is to assess the safety of 18F-TRX. Although some unknowns may remain, phase 1 trials are designed to begin understanding a treatment's safety for people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 18F-TRX imaging because it offers a new way to visualize cancer spread in the body. Unlike traditional imaging methods, 18F-TRX uses a special radioactive tracer that can highlight tumors more precisely, even in complex cases like metastatic prostate cancer or high-grade gliomas. This technique could lead to earlier and more accurate detection of metastases, helping doctors tailor treatments more effectively for patients. By potentially improving how we see and understand cancer spread, 18F-TRX imaging could play a critical role in personalizing cancer therapy.

What evidence suggests that 18F-TRX is effective for detecting tumors?

Research has shown that 18F-TRX is promising for detecting tumors. It targets and highlights unstable iron levels in tissues, which are often elevated in tumors. Studies have demonstrated that 18F-TRX can effectively identify varying iron levels in tumors, aiding in their detection. This imaging tool has successfully highlighted tumors in various cancer types, proving useful for diagnosis. In this trial, participants in Cohort 1 and Cohort 2 will receive 18F-TRX scans to evaluate its effectiveness in tumor detection. Early findings suggest it can also predict tumor response to certain treatments by assessing iron levels. ^{2 6 7 8 9}

Who Is on the Research Team?

Rahul Aggarwal, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for patients with various solid tumors, including renal cell carcinoma, prostate cancer, cerebral gliomas, and malignant glioma. Participants must be eligible based on specific inclusion and exclusion criteria set by the study.

Inclusion Criteria

Absolute neutrophil count > 1.5 x 10^6/L

Hemoglobin > 8 g/dL

Advanced solid tumor malignancy in one of the following cohorts: Cohort 1 - Any solid tumor malignancy 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 three metastatic lesions on conventional imaging, Metastatic castration-resistant prostate cancer with at least one metastatic lesion on conventional imaging

Exclusion Criteria

Individuals who are pregnant

Individuals who are breastfeeding/chestfeeding

Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive 18F-TRX intravenously and undergo PET/CT or PET/MRI scans

1 day

1-8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-7 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 18F-TRX

Trial Overview The trial is testing the safety and effectiveness of a new imaging tracer called 18F-TRX when used in PET/CT scans to detect unstable iron levels in tissues which may indicate tumor presence.

How Is the Trial Designed?

Group I: Cohort 2: Diagnostic (18F-TRX) Experimental Treatment 3 Interventions

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

Group II: Cohort 1: Diagnostic (18F-TRX) Experimental Treatment 4 Interventions

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

Who Is Running the Clinical Trial?

Rahul Aggarwal

Lead Sponsor

Trials

13

Recruited

550+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

Molecular imaging with PET is becoming increasingly important in breast cancer, with over 45 different PET tracers being tested, but currently only (18)F-FDG is widely used in clinical guidelines.

To effectively implement new PET tracers in clinical practice, standardization of technology and access to these tracers is essential, along with innovative research approaches to demonstrate their clinical value with fewer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translation of New Molecular Imaging Approaches to the Clinical Setting: Bridging the Gap to Implementation. van Es, SC., Venema, CM., Glaudemans, AW., et al.[2016]

Positron emission tomography/computed tomography (PET/CT) is a rapidly growing imaging technique in cancer management, but the commonly used radiotracer [(18)F]fluorodeoxyglucose (FDG) is not specific for malignant disease, highlighting the need for more tumor-specific PET radiopharmaceuticals.

Over the past 15 years, various alternative (18)F-labeled radiotracers have been developed and evaluated, which may provide better characterization of tumor biology, emphasizing the importance of regulatory compliance and safety in their clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(18)F-labeled positron emission tomographic radiopharmaceuticals in oncology: an overview of radiochemistry and mechanisms of tumor localization. Vallabhajosula, S.[2022]

Citations

1. withpower.com withpower.com/trial/phase-1-carcinoma-renal-cell-4-2025-ea8eb

18F-TRX Imaging for Cancer 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 ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-02615&loc=0&rl=2&t=C9384&tt=diagnostic

An Investigational Scan (18F-TRX PET/CT or PET/MRI) for ... 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33246980/

Measuring Tumoral Ferrous Iron with PET to Predict Sensitivity ... We report the first evidence-to our knowledge-that tumor sensitivity to an LIP-targeted therapy can be predicted with a molecular imaging tool.

4. ecancer.org ecancer.org/en/news/20688-novel-imaging-agent-identifies-biomarker-for-iron-targeted-cancer-therapies

Novel imaging agent identifies biomarker for iron-targeted ... 18F-TRX showed a wide range of tumour accumulation, successfully distinguishing LIP levels among tumours and determining those that might be ...

5. jnm.snmjournals.org jnm.snmjournals.org/content/62/7/949

Measuring Tumoral Ferrous Iron with PET to Predict Sensitivity ... The antitumor effects were greater than those observed against PC3 tumors, human prostate cancer with approximately 2-fold lower 18F-TRX uptake.

6. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/solid-carcinoma

UCSF Solid Carcinoma Clinical Trials for 2025 This phase I trial tests the safety and effectiveness of 18F-TRX in detecting tumors (cancer) patients with solid tumors. 18F-TRX is an ...

7. theranostictrials.org theranostictrials.org/studies/cl74bp9il0241ajjfrehseqa3

General Solid Tumors (Multiple Types) 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 ...

8. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/solid-carcinoma

Solid Carcinoma clinical trials at University of California Health This phase I trial tests the safety and effectiveness of 18F-TRX in detecting tumors (cancer) patients with solid tumors. 18F-TRX is an ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6487455/

Measuring Dynamic Changes in the Labile Iron Pool in Vivo ... Furthermore, 18F-TRX was capable of detecting elevated Fe2+ levels in tumor compared to blood pool and muscle in PC3, EKVX, and U251 xenograft ...