Clinical trial for Solid Tumor
Official title Imaging of Solid Tumors Using 18F-TRX
ClinicalTrials.gov ID: NCT06942104
What this study is testing
What is 18F-TRX?
an investigational imaging tracer being studied to detect solid tumors using PET scans is designed to bind to labile iron in tissues and emit a signal that can be visualized on PET imaging
Also referred to as Fluorine F 18 TRX.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to learn whether 18F-TRX is safe and can accurately highlight solid tumors on PET scans.
- Who it's for
- Adults who have a solid tumor such as prostate, kidney, or brain cancer.
- What's involved
- Participants will receive an injection of the 18F-TRX tracer and then have a PET/CT or PET/MRI scan to image the tumor.
- Time commitment
- The study involves a single imaging visit lasting a few hours.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Cohort 1 (n = 6): Any solid tumor malignancy with at least 3 metastatic lesions on conventional imaging
- WHO grade 3 or 4 glioma - patients with known (by integrated molecular and histopathologic diagnosis) or presumed (by imaging
- Metastatic castration-resistant prostate cancer with at least one metastatic lesion on conventional imaging including cross-sectional imaging of the...
- Ability to understand and the willingness to sign a written informed consent document.
You likely can't join if
- Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with...
- 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.
- A female is considered to not be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining...
See the full eligibility criteria
- Age ≥ 18 years
- Cohort 1 (n = 6): Any solid tumor malignancy with at least 3 metastatic lesions on conventional imaging
- WHO grade 3 or 4 glioma - patients with known (by integrated molecular and histopathologic diagnosis) or presumed (by imaging
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.