56 Participants Needed

18F-TRX Imaging for Cancer

MA
Overseen ByMaya Aslam
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment 18F-TRX for cancer?

Molecular imaging, like 18F-TRX, can help guide cancer treatment by showing how well a treatment is working early on and predicting outcomes, which can make clinical trials more effective and efficient.12345

Is 18F-TRX safe for use in humans?

There is no specific safety data available for 18F-TRX, but similar 18F-labeled radiotracers used in PET imaging have been evaluated for safety in humans, showing that they are generally safe when used in controlled doses for imaging purposes.678910

How does the treatment 18F-TRX differ from other cancer treatments?

18F-TRX is a novel imaging agent used in PET scans to detect cancer by targeting specific molecular pathways, unlike the commonly used 18F-FDG which focuses on glucose metabolism. This allows for more precise imaging of certain cancer types that may not be effectively visualized with traditional methods.26111213

What is the purpose of this trial?

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

Research Team

RA

Rahul Aggarwal, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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
See 8 more

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
See 2 more

Timeline

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)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Cohort 2: Diagnostic (18F-TRX)Experimental Treatment3 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 Treatment4 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

Find a Clinic Near You

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+

Findings from Research

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

References

How Imaging Can Impact Clinical Trial Design: Molecular Imaging as a Biomarker for Targeted Cancer Therapy. [2021]
Diagnostic performance of PET/CT with tracers other than F-18-FDG in oncology: an evidence-based review. [2021]
Translation of New Molecular Imaging Approaches to the Clinical Setting: Bridging the Gap to Implementation. [2016]
Imaging Bone Metastases in Breast Cancer: Staging and Response Assessment. [2016]
Quantitative Assessment of Early [18F]Sodium Fluoride Positron Emission Tomography/Computed Tomography Response to Treatment in Men With Metastatic Prostate Cancer to Bone. [2022]
18F-Labeled Small-Molecule and Low-Molecular-Weight PET Tracers for the Noninvasive Detection of Cancer. [2020]
Toxicology evaluation of radiotracer doses of 3'-deoxy-3'-[18F]fluorothymidine (18F-FLT) for human PET imaging: Laboratory analysis of serial blood samples and comparison to previously investigated therapeutic FLT doses. [2020]
(18)F-labeled positron emission tomographic radiopharmaceuticals in oncology: an overview of radiochemistry and mechanisms of tumor localization. [2022]
The clinical safety, biodistribution and internal radiation dosimetry of [18F]AH113804 in healthy adult volunteers. [2020]
Validation of gallbladder absorbed radiation dose reduction simulation: human dosimetry of [18F]fluortriopride. [2020]
Current molecular imaging positron emitting radiotracers in oncology. [2021]
Non FDG PET. [2016]
13.United Statespubmed.ncbi.nlm.nih.gov
Evaluation of [18F]Fluorothymidine as a Biomarker for Early Therapy Response in a Mouse Model of Colorectal Cancer. [2019]
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