Imaging study using [18F]PT2385 for renal cell carcinoma
An Exploratory Study of [18F]PT2385 PET/CT in Patients With Renal Cell Carcinoma
This study is testing a new imaging method using [18F]PT2385 to see if it can help understand tumor characteristics in people with renal cell carcinoma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT04989959 on ClinicalTrials.gov |
What this trial studies
This exploratory study assesses the use of [18F]PT2385 Positron Emission Tomography/Computed Tomography (PET/CT) in patients with renal cell carcinoma (RCC). It is an open-label, nontherapeutic trial aimed at correlating hypoxia-inducible factor-2alpha (HIF2α) levels from PET/CT scans with tissue samples analyzed by immunohistochemistry. The study includes three cohorts: patients scheduled for surgery, those with metastatic clear cell RCC, and patients with von Hippel-Lindau syndrome. Participants will undergo imaging and biopsies to evaluate the effectiveness of [18F]PT2385 in assessing HIF2α expression in tumors.
Who should consider this trial
Good fit: Ideal candidates include patients with localized or metastatic renal cell carcinoma, particularly those scheduled for surgery or requiring biopsy.
Not a fit: Patients with non-renal cell carcinoma or those unable to undergo PET/CT imaging will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of HIF2α as a therapeutic target in renal cell carcinoma, potentially leading to improved treatment strategies.
How similar studies have performed: While this approach is novel in the context of [18F]PT2385, previous studies have shown promise in using PET imaging for similar targets in renal cell carcinoma.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to understand and the willingness to sign a written informed consent that includes study interventions (PET/CT and, if cohort 2, mandatory biopsy). * Ability to lie still for a 30- to 60-minute PET/CT scan. * One of the following: 1. Cohort 1. Patients with suspected RCC planned for surgery. 2. Cohort 2. Patients with metastatic ccRCC or VHL syndrome and RCC. Biopsy is required (planned resection for treatment reasons of a metastatic site is acceptable in lieu of the biopsy). 3. Cohort 3. Patients with VHL syndrome with RCC, CNS hemangioblastoma, and/or pancreatic neuroendocrine tumor(s) planning to start belzutifan. * Patients with liver dysfunction will be considered "patients of special interest," and enrollment is allowed with or without criteria outlined for Cohorts 1-3. Liver dysfunction is defined clinically and is typically supported by abnormalities in imaging or laboratory studies (alanine / aspartate amino-transferase, bilirubin, alkaline phosphatase, or international normalized range (INR) for prothrombin time). * Women of child-bearing potential must agree to undergo and have documented a negative pregnancy test on the day of \[18F\]PT2385 administration. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or celibate by choice) who meets the following criteria: 1. Has not undergone a hysterectomy or bilateral oophorectomy; or 2. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). Exclusion Criteria: * Uncontrolled severe and irreversible intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements. * Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. * Claustrophobia or other contraindications to PET/CT. * Subjects must not weigh more than the maximum weight limit for the table for the PET/CT scanner where the study is being performed (\>200 kilograms or 440 pounds). * For cohort 2 patients, lack of suitable sites for mandatory biopsy. For example, patients with metastatic disease restricted to the lungs that would require percutaneous biopsies with associated risk of bleeding and pneumothorax will be excluded.
Where this trial is running
Dallas, Texas
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: James Brugarolas, MD, PhD — University of Texas Southwestern Medical Center
- Study coordinator: Kelli Key, PhD
- Email: Kelli.Key@UTSouthwestern.edu
- Phone: 214-648-8152
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.