Using 18F-TRX to image solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Inulin gel plus ipilimumab and nivolumab for advanced kidney (renal cell) cancer

  This trial tests whether adding an inulin gel to the immunotherapy drugs ipilimumab and nivolumab helps people with locally advanced or metastatic clear cell or sarcomatoid renal cell carcinoma.

  Recruiting Phase 1/2 University of Michigan Rogel Cancer Center · Ann Arbor, Michigan · NCT06866262

• Predicting how tumors respond to immune therapies using a live diagnostic platform

  This study is testing a new way to predict how well immune therapies will work for patients with different types of solid tumors, including early-stage and metastatic cancers.

  Recruiting at 3 sites Mayo Clinic · Phoenix, Arizona and 2 other locations · NCT06349642

• Combining cryoablation and radiation therapy for painful bone metastases

  This study is testing if combining a freezing treatment with radiation can help people with painful bone cancer feel better compared to just using radiation alone.

  Recruiting M.D. Anderson Cancer Center · Houston, Texas · NCT04693377

• VSV-IFNβ-NIS plus ipilimumab and nivolumab for advanced or metastatic clear cell renal cell carcinoma

  This trial adds a virus-based therapy (VSV-IFNβ-NIS) to standard immunotherapy (ipilimumab and nivolumab) to see if it helps people with advanced or metastatic clear cell renal cell cancer.

  Recruiting Phase 2 Mayo Clinic · Rochester, Minnesota · NCT07510334

• Morning versus afternoon immunotherapy for advanced or metastatic solid tumors

  This trial tests whether giving standard immune checkpoint inhibitor therapy in the morning versus the afternoon changes outcomes for adults with advanced or metastatic solid tumors.

  Recruiting Phase 4 OHSU Knight Cancer Institute · Portland, Oregon · NCT07405086

• Adding a probiotic to standard immunotherapy for advanced kidney cancer

  This trial tests whether adding MO-03 probiotic to standard immunotherapy helps people with advanced or metastatic clear cell kidney cancer.

  Recruiting at 41 sites Phase 3 SWOG Cancer Research Network · Fayetteville, Arkansas and 40 other locations · NCT07383441

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.