RECRUITING

Imaging of Solid Tumors Using 18F-TRX

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 Stage III Renal Cell Cancer AJCC v8 Stage IV Renal Cell Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8 Glioma, Malignant Imaging Studies

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Imaging of Solid Tumors Using 18F-TRX

Quick Facts

Study Start:2025-07-03

Study Completion:2026-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06942104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Maya Aslam

CONTACT

(415) 514-8987

Maya.Aslam@ucsf.edu

Principal Investigator

Rahul Aggarwal, MD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco

San Francisco, California, 94143

United States

Collaborators and Investigators

Sponsor: Rahul Aggarwal

Rahul Aggarwal, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-03

Study Completion Date2026-09-30

Study Record Updates

Study Start Date2025-07-03

Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

Imaging Studies

Additional Relevant MeSH Terms

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