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[18F]PT2385 PET/CT in Renal Cell Carcinoma

This study is looking at how a special imaging scan, called an [18F]PT2385 PET/CT, works in people with kidney cancer (renal cell carcinoma). The researchers want to see if this scan can accurately measure levels of a protein called HIF2α in your tumors. HIF2α is a target for new treatments. You might be able to join if you have kidney cancer and are planning surgery, or if your kidney cancer has spread (metastatic) or you have VHL syndrome. The study is open to adults aged 18 and older. The main goal is to compare the scan results with what is found in a tumor sample, with observations lasting up to 5 years. The study status is currently unclear.

Study design
This is an exploratory, open-label study, meaning you and the researchers will know what interventions you receive. It aims to enroll 35 participants.
What's involved
You would have an [18F]PT2385 infusion, followed by a PET/CT scan. Some participants may also have a CT-guided tumor biopsy.
Compensation
Not stated in the trial record.
Follow-up
The study will track the correlation between the scan results and tumor samples for up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04989959

[18F]PT2385 PET/CT in Patients With Renal Cell Carcinoma

Recruiting
PHASE1Ages 18+InterventionalDiagnostic
Orhan Kemal Oz
~35 participants
Updated 2025-12-04 on ClinicalTrials.gov
What's tested:[18F]PT2385Positron Emission Tomography/Computed TomographyBiopsy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Correlation between [18F]PT2385 and HIF2α
Measured over Up to 5 years
+1 more outcome measured

Conditions

Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma

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Clear Cell Renal Cell CarcinomaHemangioblastomaPancreatic Neuroendocrine TumorRenal Cell CarcinomaVon Hippel Lindau Syndrome

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • James Brugarolas, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

Kelli Key, PhD
[email protected]
214-648-8152
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
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:

Exclusion

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.

What this trial measures

  • Correlation between [18F]PT2385 and HIF2αUp to 5 years

    Correlation between \[18F\]PT2385 PET avidity and HIF2α expression in primary tumors

  • Correlation between [18F]PT2385 and HIF2α IHCUp to 5 years

    Correlation between \[18F\]PT2385 PET avidity and HIF2α expression by IHC