Imaging Solid Tumors with 18F-TRX

This study is testing a new imaging tracer called 18F-TRX to see how safely and effectively it can find solid tumors in your body. 18F-TRX is given through a vein (intravenously) and works with a PET/CT scan (Positron Emission Tomography/Computerized Tomography, a type of imaging) to highlight tumors by targeting unstable iron levels. The study is looking at people aged 18 and older with advanced solid tumors, including certain prostate, kidney, and brain cancers. The main goal is to check for any side effects from 18F-TRX. This study is currently unclear on its recruitment status and plans to enroll 56 participants.

Study design
This is an interventional study with 56 planned participants. It is testing the safety and effectiveness of 18F-TRX for imaging solid tumors.
What's involved
You may receive 18F-TRX intravenously, undergo PET/CT imaging, have blood samples taken, and potentially have a tumor biopsy.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured for up to 7 days after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06942104

Imaging of Solid Tumors Using 18F-TRX

Recruiting
PHASE1Ages 18+InterventionalDiagnostic
Rahul Aggarwal
~56 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:18F-TRXPositron Emission Tomography (PET)/Computerized tomography (CT)Tumor BiopsyBlood Specimen Collection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants with treatment-emergent adverse events
Measured over Up to 7 days
Solid Tumor
Solid Carcinoma
Castration-Resistant Prostate Carcinoma
Locally Advanced Clear Cell Renal Cell Carcinoma
Metastatic Clear Cell Renal Cell Carcinoma
Metastatic Malignant Solid Neoplasm
Stage III Renal Cell Cancer AJCC v8
Stage IV Renal Cell Cancer AJCC v8
Stage IVB Prostate Cancer AJCC v8
Glioma, Malignant
1 sites across 1 states
California1
  • Rahul Aggarwal, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

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Eligibility criteria

Inclusion

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

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.
  • Proportion of participants with treatment-emergent adverse eventsUp 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.