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[18F]PT2385 PET/CT Scan for Kidney Cancer

Phase 1
Recruiting
Led By James Brugarolas, MD, PhD
Research Sponsored by Orhan Kemal Oz
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to understand and the willingness to sign a written informed consent that includes study interventions (PET/CT and, if cohort 2, mandatory biopsy)
Be older than 18 years old
Must not have
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
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at a new way to scan for kidney cancer using PET/CT and HIF2α immunohistochemistry. The first cohort will be patients who are scheduled for nephrectomy (removal of the kidney), and the second cohort will be patients with metastatic ccRCC. The goal is to see if the new scan can predict how the cancer will respond to treatment.

Who is the study for?
This trial is for patients with suspected or confirmed renal cell carcinoma (RCC). It includes those planned for surgery, with metastatic clear cell RCC, or Von Hippel-Lindau syndrome with related tumors. Participants must be able to lie still for PET/CT scans and women of childbearing potential need a negative pregnancy test. Exclusions include severe illnesses, pregnancy, nursing mothers, over the weight limit for PET/CT scanners (>440 pounds), claustrophobia, and unsuitable biopsy sites.
What is being tested?
[18F]PT2385 PET/CT imaging is being tested to see how well it shows levels of HIF2α in kidney cancer compared to tissue tests after surgery or biopsy. The study has three groups: one getting scans before kidney removal; another with metastatic cancer where scan results are matched against biopsies; and a third group with VHL syndrome who may have different types of tumors.
What are the potential side effects?
As an imaging study using [18F]PT2385 PET/CT scans primarily involves exposure to radiation similar to standard medical imaging procedures, potential side effects may include temporary discomfort from lying still during the scan and risks associated with biopsies such as bleeding or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can understand and am willing to sign the consent form for the study's procedures.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot safely undergo a biopsy due to the location of my cancer.
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I weigh less than 440 pounds.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Correlation between [18F]PT2385 and HIF2α
Correlation between [18F]PT2385 and HIF2α IHC

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Pre-SurgicalExperimental Treatment2 Interventions
Patients with suspected RCC planned for surgery
Group II: Planned belzutifan treatmentExperimental Treatment2 Interventions
Patients with VHL syndrome with RCC, CNS hemangioblastoma, and/or pancreatic neuroendocrine tumor(s) planning to start belzutifan.
Group III: Metastatic or VHL SyndromeExperimental Treatment3 Interventions
Patients with metastatic ccRCC or VHL syndrome and RCC
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography/Computed Tomography
2020
Completed Phase 2
~20
Biopsy
2014
Completed Phase 4
~1090

Find a Location

Who is running the clinical trial?

Orhan Kemal OzLead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
Neil M Rofsky, MD, MHALead Sponsor
1 Previous Clinical Trials
125 Total Patients Enrolled
James Brugarolas, MD, PhDPrincipal InvestigatorUT Southwestern Medical Center
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

[18F]PT2385 Clinical Trial Eligibility Overview. Trial Name: NCT04989959 — Phase 1
Kidney Cancer Research Study Groups: Pre-Surgical, Metastatic or VHL Syndrome, Planned belzutifan treatment
Kidney Cancer Clinical Trial 2023: [18F]PT2385 Highlights & Side Effects. Trial Name: NCT04989959 — Phase 1
[18F]PT2385 2023 Treatment Timeline for Medical Study. Trial Name: NCT04989959 — Phase 1
~12 spots leftby Aug 2026
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