A Phase 1 interventional study of 18F-TRX and Positron Emission Tomography (PET)/Computerized tomography (CT) in Solid Tumor, Solid Carcinoma and Castration-Resistant Prostate Carcinoma, sponsored by Rahul Aggarwal. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Rahul Aggarwal · Phase 1, Interventional, and Diagnostic
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
PRIMARY OBJECTIVE:
I. To determine the safety of fluorine F 18 trioxolane (18F-TRX) in participants with any solid tumor malignancy with at least 3 metastatic lesions on conventional imaging (Cohort 1); or known or presumed high grade glioma, locally advanced metastatic clear cell renal cell carcinoma with at least 3 lesions on conventional imaging, and metastatic castration-resistant prostate cancer (mCRPC) with at least 1 metastatic lesion on conventional imaging (Cohort 2).
SECONDARY OBJECTIVES:
I. To determine the organ dosimetry and pharmacokinetics of 18F-TRX (Cohort 1).
II. To determine the sensitivity for detection of malignant lesions with 18F-TRX PET in participants with metastatic castration-resistant prostate cancer (n = 30), locally advanced or metastatic clear cell renal cell carcinoma (n = 10), and World Health Organization (WHO) grade 3 or 4 glioma (n = 10) (Cohort 2).
III. To determine the feasibility of lesion detection using 18F-TRX in participants with known or presumed high grade glioma, locally advanced metastatic clear cell renal cell carcinoma with at least 3 lesions on conventional imaging, and mCRPC with at least 1 metastatic lesion on conventional imaging (Cohort 2).
EXPLORATORY OBJECTIVE:
I. To correlate 18F-TRX uptake with Six-Transmembrane Epithelial Antigen of Prostate 3 (STEAP3) expression determined by immunohistochemistry (IHC) evaluation of tumor tissue obtained within 3 months of PET.
OUTLINE:
Participants are assigned to 1 of 2 cohorts:
COHORT 1: Participants receive 18F-TRX intravenously (IV) and undergo up to 8 PET/CT or PET/MRI scans.
COHORT 2: Participants receive 18F-TRX IV and undergo a single scan.
After completion of study intervention, patients are followed up 1-7 days post-injection.
39 studies on the registry are indexed under Clear-cell metastatic renal cell carcinoma; 26 are open to participants now.
This study's planned enrollment of 56 is above the median of 37 across 35 interventional studies indexed under Clear-cell metastatic renal cell carcinoma.
Browse Clear-cell metastatic renal cell carcinoma studies →Rahul Aggarwal is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.
Counted across the registry records on this site, refreshed daily.
Advanced solid tumor malignancy in one of the following cohorts:
Cohort 2 (n = 50):
Exclusion Criteria:
Individuals who are pregnant.
Individuals who are breastfeeding/chestfeeding.
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
Drug: 18F-TRX · Procedure: Positron Emission Tomography (PET)/Computerized tomography (CT) · Procedure: Tumor Biopsy · Procedure: Blood Specimen Collection
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
Drug: 18F-TRX · Procedure: Positron Emission Tomography (PET)/Computerized tomography (CT) · Procedure: Tumor Biopsy
Given Intravenously (IV)
Also known as: Fluorine F 18 TRX
Imaging procedure
Also known as: PET/CT
May undergo tumor biopsy
Also known as: Biopsy
Undergo blood sample collection
Also known as: Blood Sample, Sample Collection
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.
Time frame: Up to 7 days
Median Target to Background Ratio (TBR) (Cohort 1)
The measured target-to-background ratios (TBRs) will be reported as the median and range similar to previously reported. The scan time point generating the highest mean TBR will be chosen for subsequent imaging in cohort 2.
Time frame: Day of scan, 1 day
Mean radiation-absorbed doses (Cohort 1)
The results from the scans for all patients enrolled will be combined to allow the calculation of mean, standard deviation (SD), and range of radiation-absorbed doses to individual organs as well as effective dose
Time frame: Day of scan, 1 day
Sensitivity of tumor lesion detection (Cohort 2)
Sensitivity is the probability that a test will indicate a lesion among those with disease: Sensitivity = True Positive / (True Positive + False Negative). The lesion is defined as positive if the short axis dimension of lymph nodes is greater than 1.5 cm, and organ metastases measure \> 1 cm in long axis by conventional imaging. The sensitivity will be obtained by point estimation and 95% confidence interval assuming all lesions are independent to determine the number of tru
Time frame: Day of scan, 1 day
Number of lesions detected by fludeoxyglucose F-18 (18F)-TRX positron emission tomography (PET) (Cohort 2)
Number of lesions detected by 18F-TRX PET, but not detected on conventional imaging.
Time frame: Day of scan, 1 day
Proportion of patients with one or more metastatic lesion (Cohort 2)
Feasibility will be assessed by conventional imaging (computed tomography and magnetic resonance imaging) and whole-body bone scan, and will be reviewed in conjunction with the 18F-TRX PET images. Conventional imaging will be interpreted as positive by each lesion if the short axis dimension of lymph nodes is greater than 1.5 cm, and organ metastases measure greater than 1 cm in long axis. The gold standard will be conventional imaging. Will be descriptively reported with point estimation and 95% confidence interval.
Time frame: Day of scan, 1 day
Plan to share: No
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Rahul Aggarwal