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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I can understand and am willing to sign the consent form for the study's procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Correlation between [18F]PT2385 and HIF2α

Correlation between [18F]PT2385 and HIF2α IHC

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

0 / 1Eligibility criteria met

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

Renal Cell Carcinoma Research Study Groups: Metastatic or VHL Syndrome, Pre-Surgical, Planned belzutifan treatment

Renal Cell Carcinoma 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers still enlisting participants for this research project?

"Affirmative, according to the details on clinicaltrials.gov this medical research is still seeking participants that meet the criteria for inclusion. This trial was first published on August 18th 2021 and most recently updated on November 18 2022; 50 individuals from one centre of study are needed."

Answered by AI

Are there any analogous studies involving [18F]PT2385?

"At present, there are 3 clinical trials in session exploring the effects of [18F]PT2385. None of these active research initiatives have advanced to Phase 3 yet. Although most tests related to this medication are conducted at Bethesda, Maryland, 27 other sites across the country offer trial opportunities as well."

Answered by AI

What potential risks exist with using [18F]PT2385?

"The data from our team at Power regarding the safety of [18F]PT2385 was cautiously optimistic, assigning it a score of 1. This is due to this being an exploratory Phase 1 study with limited evidence for efficacy and safety."

Answered by AI

Does this experiment represent a pioneering step in the field of medical research?

"In 22 cities and 1 nation, there are currently 3 extant trials for [18F]PT2385. The initial trial was backed by Peloton Therapeutics, Inc., in 2014; this Phase 1 drug approval study included 110 participants and has since been completed 42 times."

Answered by AI

What is the capacity of this study in terms of participant uptake?

"Affirmative. According to the details available on clinicaltrials.gov, this trial is presently recruiting patients who were posted since August 18th 2021 and last modified November 18th 2022. 50 individuals are required across a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Orhan Kemal Oz 2021. "[18F]PT2385 PET/CT in Patients With Renal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04989959.

All > Renal Cell Carcinoma