Imaging of Solid Tumors Using 18F-TRX

July 17, 2025 updated by: Rahul Aggarwal
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To determine the safety of fluorine F 18 trioxolane (18F-TRX) in participants with any solid tumor malignancy with at least 3 metastatic lesions on conventional imaging (Cohort 1); or known or presumed high grade glioma, locally advanced metastatic clear cell renal cell carcinoma with at least 3 lesions on conventional imaging, and metastatic castration-resistant prostate cancer (mCRPC) with at least 1 metastatic lesion on conventional imaging (Cohort 2).

SECONDARY OBJECTIVES:

I. To determine the organ dosimetry and pharmacokinetics of 18F-TRX (Cohort 1).

II. To determine the sensitivity for detection of malignant lesions with 18F-TRX PET in participants with metastatic castration-resistant prostate cancer (n = 30), locally advanced or metastatic clear cell renal cell carcinoma (n = 10), and World Health Organization (WHO) grade 3 or 4 glioma (n = 10) (Cohort 2).

III. To determine the feasibility of lesion detection using 18F-TRX in participants with known or presumed high grade glioma, locally advanced metastatic clear cell renal cell carcinoma with at least 3 lesions on conventional imaging, and mCRPC with at least 1 metastatic lesion on conventional imaging (Cohort 2).

EXPLORATORY OBJECTIVE:

I. To correlate 18F-TRX uptake with Six-Transmembrane Epithelial Antigen of Prostate 3 (STEAP3) expression determined by immunohistochemistry (IHC) evaluation of tumor tissue obtained within 3 months of PET.

OUTLINE:

Participants are assigned to 1 of 2 cohorts:

COHORT 1: Participants receive 18F-TRX intravenously (IV) and undergo up to 8 PET/CT or PET/MRI scans.

COHORT 2: Participants receive 18F-TRX IV and undergo a single scan.

After completion of study intervention, patients are followed up 1-7 days post-injection.

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rahul Aggarwal, MD
        • Principal Investigator:
          • Spencer Behr, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Individuals receiving strong inhibitors or inducers of CYP3A4.
  • Uncontrolled active infection or other medical condition that would preclude safe participation in the study as judged by the Investigator.

  • Individuals who are pregnant.

    • Individuals of childbearing potential (defined below) must agree to undergo a urine pregnancy test prior to participating in the study scans. Pregnant individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn child secondary to administration of 18F-TRX to the study participant.
    • A female is considered to not be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if the participant meets either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries).

  • Individuals who are breastfeeding/chestfeeding.

    • Breastfeeding/chestfeeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn/nursing child secondary to administration of 18F-TRX to the study participant.
    • Breastfeeding/chestfeeding should be discontinued before administration of 18F-TRX.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: 18F-TRX
Given Intravenously (IV)
Other Names:
  • Fluorine F 18 TRX
Procedure: Positron Emission Tomography (PET)/Computerized tomography (CT)
Imaging procedure
Other Names:
  • PET/CT
Procedure: Tumor Biopsy
May undergo tumor biopsy
Other Names:
  • Biopsy
Procedure: Blood Specimen Collection
Undergo blood sample collection
Other Names:
  • Blood Sample
  • Sample Collection
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
Drug: 18F-TRX
Given Intravenously (IV)
Other Names:
  • Fluorine F 18 TRX
Procedure: Positron Emission Tomography (PET)/Computerized tomography (CT)
Imaging procedure
Other Names:
  • PET/CT
Procedure: Tumor Biopsy
May undergo tumor biopsy
Other Names:
  • Biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with treatment-emergent adverse events
Time Frame: Up to 7 days
The proportion of participants with any treatment-emergent adverse events will be reported by grade and frequency per the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. All participants who receive the radiotracer injection will be evaluable.
Up to 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Target to Background Ratio (TBR) (Cohort 1)
Time Frame: Day of scan, 1 day
The measured target-to-background ratios (TBRs) will be reported as the median and range similar to previously reported. The scan time point generating the highest mean TBR will be chosen for subsequent imaging in cohort 2.
Day of scan, 1 day
Mean radiation-absorbed doses (Cohort 1)
Time Frame: Day of scan, 1 day
The results from the scans for all patients enrolled will be combined to allow the calculation of mean, standard deviation (SD), and range of radiation-absorbed doses to individual organs as well as effective dose
Day of scan, 1 day
Sensitivity of tumor lesion detection (Cohort 2)
Time Frame: Day of scan, 1 day
Sensitivity is the probability that a test will indicate a lesion among those with disease: Sensitivity = True Positive / (True Positive + False Negative). The lesion is defined as positive if the short axis dimension of lymph nodes is greater than 1.5 cm, and organ metastases measure > 1 cm in long axis by conventional imaging. The sensitivity will be obtained by point estimation and 95% confidence interval assuming all lesions are independent to determine the number of tru
Day of scan, 1 day
Number of lesions detected by fludeoxyglucose F-18 (18F)-TRX positron emission tomography (PET) (Cohort 2)
Time Frame: Day of scan, 1 day
Number of lesions detected by 18F-TRX PET, but not detected on conventional imaging.
Day of scan, 1 day
Proportion of patients with one or more metastatic lesion (Cohort 2)
Time Frame: Day of scan, 1 day
Feasibility will be assessed by conventional imaging (computed tomography and magnetic resonance imaging) and whole-body bone scan, and will be reviewed in conjunction with the 18F-TRX PET images. Conventional imaging will be interpreted as positive by each lesion if the short axis dimension of lymph nodes is greater than 1.5 cm, and organ metastases measure greater than 1 cm in long axis. The gold standard will be conventional imaging. Will be descriptively reported with point estimation and 95% confidence interval.
Day of scan, 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rahul Aggarwal

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Rahul Aggarwal, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

April 16, 2025

First Submitted That Met QC Criteria

April 16, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

July 18, 2025

Last Update Submitted That Met QC Criteria

July 17, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 249214
  • NCI-2025-02615 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Solid Tumor

Clinical Trials on 18F-TRX

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe