Renal Cell Carcinoma study: [18F]PT2385 vs Biopsy
Official title [18F]PT2385 PET/CT in Patients With Renal Cell Carcinoma
ClinicalTrials.gov ID: NCT04989959
What this study is testing
What is [18F]PT2385?
[18F]PT2385 is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for renal cell carcinoma.
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
- This study is testing whether the [18F]PT2385 PET/CT scan can show the amount of a protein called HIF2α in kidney cancer. It will compare the scan results with tissue samples.
- Who it's for
- You may be able to join if you have kidney cancer, especially clear cell type, or if you have Von Hippel-Lindau syndrome with kidney, brain, or pancreas tumors.
- What's involved
- You will have a PET/CT scan that uses a small amount of a radioactive tracer. In some groups you may also have a biopsy of your tumor or a metastasis. The scan results will be compared to the tissue sample.
- Time commitment
- The study lasts a few weeks. You will need to come in for the PET/CT scan and possibly a biopsy, and then follow up with the study team as directed.
- 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
- Ability to understand and the willingness to sign a written informed consent that includes study interventions (PET/CT and, if cohort 2, mandatory...
- Ability to lie still for a 30- to 60-minute PET/CT scan.
- Cohort 1. Patients with suspected RCC planned for surgery.
- Cohort 2. Patients with metastatic ccRCC or VHL syndrome and RCC. Biopsy is required (planned resection for treatment reasons of a metastatic site is...
- Cohort 3. Patients with VHL syndrome with RCC, CNS hemangioblastoma, and/or pancreatic neuroendocrine tumor(s) planning to start belzutifan.
You likely can't join if
- Uncontrolled severe and irreversible intercurrent illness or psychiatric illness/social situations that would limit compliance with study...
- people 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.
- people 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...
- For cohort 2 patients, lack of suitable sites for mandatory biopsy.
See the full eligibility 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.
- Cohort 1. Patients with suspected RCC planned for surgery.
- 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).
- 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.
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- 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).
- Uncontrolled severe and irreversible intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
- people 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.
- people 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Dallas, Texas, 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 Dallas, Texas, 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.