Imaging of Solid Tumors Using 18F-TRX
2 other identifiers
interventional
56
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2025
CompletedFirst Posted
Study publicly available on registry
April 24, 2025
CompletedStudy Start
First participant enrolled
July 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
July 18, 2025
July 1, 2025
1.2 years
April 16, 2025
July 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of participants with treatment-emergent adverse events
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 Outcomes (5)
Median Target to Background Ratio (TBR) (Cohort 1)
Day of scan, 1 day
Mean radiation-absorbed doses (Cohort 1)
Day of scan, 1 day
Sensitivity of tumor lesion detection (Cohort 2)
Day of scan, 1 day
Number of lesions detected by fludeoxyglucose F-18 (18F)-TRX positron emission tomography (PET) (Cohort 2)
Day of scan, 1 day
Proportion of patients with one or more metastatic lesion (Cohort 2)
Day of scan, 1 day
Study Arms (2)
Cohort 1: Diagnostic (18F-TRX)
EXPERIMENTALParticipants 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
Cohort 2: Diagnostic (18F-TRX)
EXPERIMENTALParticipants 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
Given Intravenously (IV)
Imaging procedure
May undergo tumor biopsy
Undergo blood sample collection
Eligibility Criteria
You may qualify if:
- 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).
- +1 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rahul Aggarwallead
- United States Department of Defensecollaborator
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rahul Aggarwal, MD
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 16, 2025
First Posted
April 24, 2025
Study Start
July 3, 2025
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
July 18, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share