Using 18F-TRX to image solid tumors
Imaging of Solid Tumors Using 18F-TRX
This trial tests whether the 18F-TRX PET tracer can detect tumors in adults with advanced solid tumors such as high‑grade glioma, clear cell renal cell carcinoma, or metastatic castration‑resistant prostate cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06942104 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional trial administers 18F-TRX followed by PET imaging (PET/CT or PET/MRI) to visualize labile iron within tumors and surrounding tissues. Participants are assigned to two cohorts: Cohort 1 (any solid tumor with ≥3 metastatic lesions) for initial safety and dosimetry, and Cohort 2 (high‑grade glioma, locally advanced/metastatic clear cell RCC with ≥3 lesions, or mCRPC with ≥1 lesion) for lesion detection testing. Procedures include serial imaging for organ dosimetry and pharmacokinetics, tumor biopsy and blood collection for correlative studies, and comparison of 18F-TRX uptake with conventional imaging. Primary outcomes focus on safety and dosimetry while secondary outcomes measure sensitivity and feasibility of lesion detection and correlation with STEAP3 expression.
Who should consider this trial
Good fit: Adults (age ≥18) with advanced solid tumors who meet cohort-specific lesion requirements—either any solid tumor with ≥3 metastatic lesions (Cohort 1) or high‑grade glioma, clear cell renal cell carcinoma with ≥3 lesions, or metastatic castration‑resistant prostate cancer with ≥1 lesion (Cohort 2)—and who can consent and undergo imaging and biopsy procedures.
Not a fit: Patients without measurable metastatic lesions, those unable to undergo PET imaging or biopsy, or those with early‑stage disease are unlikely to receive direct benefit from this imaging study.
Why it matters
Potential benefit: If successful, 18F-TRX PET could improve tumor detection and characterization by highlighting unstable iron in cancer tissue, potentially helping doctors choose better treatment strategies.
How similar studies have performed: Iron-targeting PET tracers are a relatively novel approach with promising preclinical data and limited prior human imaging experience, but widespread clinical success has not yet been established.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Rahul Aggarwal, MD — University of California, San Francisco
- Study coordinator: Maya Aslam
- Email: Maya.Aslam@ucsf.edu
- Phone: (415) 514-8987
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.