Phase 1 Kidney Cancer Trial, Recruiting NCT04989959 Sponsor: Orhan Kemal Oz Condition: Kidney Cancer
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Phase 1 Kidney Cancer Trial, Recruiting

NCT04989959
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are able to understand the study and are willing to sign a written consent form, which includes agreeing to a PET/CT scan and, for one group, a tissue biopsy.
  • People who are able to lie still for 30 to 60 minutes during a PET/CT scan.
  • People who fall into one of these three groups:
    • Group 1: People with suspected kidney cancer who are already scheduled for surgery.
    • Group 2: People with advanced (metastatic) clear cell kidney cancer, or with a genetic condition called VHL syndrome along with kidney cancer, who are able to have a tissue sample (biopsy) taken. A planned surgical removal of a metastatic site for treatment reasons may be accepted instead of a biopsy.
    • Group 3: People with VHL syndrome who have kidney cancer, brain or spinal tumours called hemangioblastomas, and/or pancreatic neuroendocrine tumours, and who are planning to start a medicine called belzutifan.
  • People with liver problems may also be considered for the trial, even if they do not fully fit into Groups 1–3. Liver problems are typically identified through blood tests or medical imaging (confirm with trial site).
  • Women who could become pregnant must have a documented negative pregnancy test on the day the study drug is given.

Who may not be able to join:

  • People with serious, uncontrolled, or long-term illness, or mental health or personal circumstances that would make it difficult to follow the study requirements.
  • People who are currently pregnant or breastfeeding, due to potential risks to the baby.
  • People who have claustrophobia or any other medical reason that would prevent them from having a PET/CT scan.
  • People who weigh more than 200 kilograms (440 pounds), as this exceeds the weight limit for the scanning equipment.
  • People in Group 2 for whom no suitable biopsy site is available — for example, those whose cancer has spread only to the lungs, where taking a biopsy would carry too high a risk of complications such as bleeding or lung collapse.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 15 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: James Brugarolas, MD, PhD, University of Texas Southwestern Medical Center

Phone: 214-648-8152

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Orhan Kemal Oz
Registry
ClinicalTrials.gov
Start date
18 August 2021
Est. completion
18 August 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Correlation between [18F]PT2385 and HIF2α; Correlation between [18F]PT2385 and HIF2α IHC

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov