Recruiting
Phase 1

18F-TRX

Sponsor:

Rahul Aggarwal

Code:

NCT06942104

Conditions

Solid Tumor

Solid Carcinoma

Castration-Resistant Prostate Carcinoma

Locally Advanced Clear Cell Renal Cell Carcinoma

Metastatic Clear Cell Renal Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

18F-TRX

Positron Emission Tomography (PET)/Computerized tomography (CT)

Tumor Biopsy

Blood Specimen Collection

Study Details

Brief summary:

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

Conditions

Solid Tumor

Solid Carcinoma

Castration-Resistant Prostate Carcinoma

Locally Advanced Clear Cell Renal Cell Carcinoma

Metastatic Clear Cell Renal Cell Carcinoma

Study ID

NCT06942104

Start date

Jul 3, 2025

Status verified date

Jul, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

56 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

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

Interventions

18F-TRX

Given Intravenously (IV)

Positron Emission Tomography (PET)/Computerized tomography (CT)

Imaging procedure

Tumor Biopsy

May undergo tumor biopsy

Blood Specimen Collection

Undergo blood sample collection

Primary outcome measure

  • Proportion of participants with treatment-emergent adverse events [ Time Frame: Up to 7 days ]

Central Contacts and Locations

Central contacts

Maya Aslam

(415) 514-8987Maya.Aslam@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Maya Aslam

415-514-8987Maya.Aslam@ucsf.edu

877-827-3222cancertrials@ucsf.edu

Principal Investigator:

Spencer Behr, MD

More Information

Sponsor

Rahul Aggarwal

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • Imaging Studies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rahul Aggarwal on 2026-07-23.