Solid TumorPhase 1NCT06942104
Imaging of Solid Tumors Using 18F-TRX
A Phase 1 study testing 18F-TRX, Positron Emission Tomography (PET)/Computerized tomography (CT) and Tumor Biopsy in people with Solid Tumor and Solid Carcinoma, run by Rahul Aggarwal at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Solid Carcinoma, Castration-Resistant Prostate Carcinoma
- What is being tested?
- 18F-TRX, Positron Emission Tomography (PET)/Computerized tomography (CT) and Tumor Biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2025to 30 Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Maya Aslam, 415-514-8987, Maya.Aslam@ucsf.edu
877-827-3222, cancertrials@ucsf.edu
About this study
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
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
- Conditions
- 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
- Being tested
- 18F-TRX, Positron Emission Tomography (PET)/Computerized tomography (CT), Tumor Biopsy, Blood Specimen Collection
- Keywords
- Imaging Studies
- Medical subject headings
- Clear-cell metastatic renal cell carcinoma, Neoplasm Metastasis, Carcinoma, Renal Cell, Prostatic Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-TRXDrug
Also called Fluorine F 18 TRX
Given Intravenously (IV)
Positron Emission Tomography (PET)/Computerized tomography (CT)Procedure or surgery
Also called PET/CT
Imaging procedure
Tumor BiopsyProcedure or surgery
Also called Biopsy
May undergo tumor biopsy
Blood Specimen CollectionProcedure or surgery
Also called Blood Sample, Sample Collection
Undergo blood sample collection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Diagnostic (18F-TRX) | Experimental | 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 Receives: Drug: 18F-TRX; Procedure: Positron Emission Tomography (PET)/Computerized tomography (CT); Procedure: Tumor Biopsy; Procedure: Blood Specimen Collection |
| Cohort 2: Diagnostic (18F-TRX) | Experimental | 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 Receives: Drug: 18F-TRX; Procedure: Positron Emission Tomography (PET)/Computerized tomography (CT); Procedure: Tumor Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 7 days
Secondary outcomes (5)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Day of scan, 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start3 Jul 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rahul Aggarwal
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, Rahul Aggarwal, University of California, San Francisco
- Investigators
- Rahul Aggarwal, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942104
- Sponsor's protocol ID
- 249214
- Other IDs
- NCI-2025-02615
- Status last verified
- Jul 2026
- First submitted
- 16 Apr 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Solid Tumors Using 18F-TRX
- ClinicalTrials.gov ID
- NCT06942104
- Acronym / sponsor ID
- 249214
- Conditions
- 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
- Keywords
- Imaging Studies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Rahul AggarwalUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Diagnostic (18F-TRX) | Experimental | Drug: 18F-TRX, Procedure: Positron Emission Tomography (PET)/Computerized tomography (CT), Procedure: Tumor Biopsy, Procedure: Blood Specimen CollectionParticipants 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) | Experimental | Drug: 18F-TRX, Procedure: Positron Emission Tomography (PET)/Computerized tomography (CT), Procedure: Tumor BiopsyParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 18 years
- Advanced solid tumor malignancy in one of the following cohorts:
- 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.
Key exclusion criteria (9 listed)
- 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 who are breastfeeding/chestfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-TRXAlso: Fluorine F 18 TRXGiven Intravenously (IV) | Drug | Cohort 1: Diagnostic (18F-TRX), Cohort 2: Diagnostic (18F-TRX) |
| Positron Emission Tomography (PET)/Computerized tomography (CT)Also: PET/CTImaging procedure | Procedure or surgery | Cohort 1: Diagnostic (18F-TRX), Cohort 2: Diagnostic (18F-TRX) |
| Tumor BiopsyAlso: BiopsyMay undergo tumor biopsy | Procedure or surgery | Cohort 1: Diagnostic (18F-TRX), Cohort 2: Diagnostic (18F-TRX) |
| Blood Specimen CollectionAlso: Blood Sample, Sample CollectionUndergo blood sample collection | Procedure or surgery | Cohort 1: Diagnostic (18F-TRX) |
Primary outcome
Proportion of participants with treatment-emergent adverse events
Time frame: Up 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.
5 secondary outcomes
Median Target to Background Ratio (TBR) (Cohort 1)
Time frame: Day of scan, 1 day
Mean radiation-absorbed doses (Cohort 1)
Time frame: Day of scan, 1 day
Sensitivity of tumor lesion detection (Cohort 2)
Time frame: Day of scan, 1 day
Number of lesions detected by fludeoxyglucose F-18 (18F)-TRX positron emission tomography (PET) (Cohort 2)
Time frame: Day of scan, 1 day
Proportion of patients with one or more metastatic lesion (Cohort 2)
Time frame: Day of scan, 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rahul Aggarwal, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 18F-TRX, Positron Emission Tomography (PET)/Computerized tomography (CT) and Tumor Biopsy in people with Solid Tumor and Solid Carcinoma, run by Rahul Aggarwal at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maya Aslam ((415) 514-8987, Maya.Aslam@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with treatment-emergent adverse events (time frame: Up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.