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ImmunoPET/CT Imaging for Kidney Cancer

Phase 2

Recruiting

Led By Orhan Oz, 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

Patient must be able to lie still for a 30 to 60 minute PET/CT scan.

Patients with locally advanced RCC planned for surgery determined to be a high risk of recurrence, defined by presence of at least clinical T2 or TxN1, OR patients with metastatic RCC for whom treatment with cytoreductive nephrectomy and/or metastasectomy is planned by the treating physician.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will explore whether a new imaging scan can predict how well a patient with renal cell carcinoma will respond to immunotherapy.

Who is the study for?

This trial is for adults with advanced or metastatic kidney cancer who can consent to the study, are not pregnant, and do not have severe allergies to atezolizumab. Participants must be able to lie still for a PET/CT scan and should either be planned for kidney surgery or about to start immune therapy.Check my eligibility

What is being tested?

The trial tests if a special type of PET/CT scan using 89Zr-DFO-Atezolizumab can show how much PD-L1 protein is in the tumor and predict response to immune checkpoint inhibitors. It includes two groups: one undergoing surgery and another starting immunotherapy.See study design

What are the potential side effects?

Potential side effects may include allergic reactions related to atezolizumab, though risks are low as the dose used for imaging is small. The procedure might also cause discomfort from lying still during scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can stay still for up to an hour for a scan.

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I have advanced kidney cancer with a high risk of coming back or it has spread, and surgery is planned.

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I have kidney cancer that has spread, and I am planning to undergo immunotherapy.

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 89Zr-DFO-Atezolizumab and PD-L1

Correlation between 89Zr-DFO-Atezolizumab and anti-PD1/PD-L1 therapy

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2Experimental Treatment2 Interventions

Patients with Unresectable/Metastatic RCC prior to treatment with an immune checkpoint inhibitor.

Group II: Cohort 1Experimental Treatment2 Interventions

Patients with Localized RCC prior to nephrectomy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography/Computed Tomography

2020

Completed Phase 2

~20

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Orhan Kemal OzLead Sponsor

1 Previous Clinical Trials

80 Total Patients Enrolled

James BrugarolasLead Sponsor

Orhan Oz, MD, PhDPrincipal InvestigatorUT Southwestern Medical Center

Media Library

89Zr-DFO-Atezolizumab Clinical Trial Eligibility Overview. Trial Name: NCT04006522 — Phase 2

Kidney Cancer Research Study Groups: Cohort 1, Cohort 2

Kidney Cancer Clinical Trial 2023: 89Zr-DFO-Atezolizumab Highlights & Side Effects. Trial Name: NCT04006522 — Phase 2

89Zr-DFO-Atezolizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT04006522 — Phase 2

Frequently Asked Questions

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

What medical condition is 89Zr-DFO-Atezolizumab typically employed to address?

"89Zr-DFO-Atezolizumab has been demonstrated to be efficacious in the treatment of small cell lung cancer (sclc), malignant neoplasms, and non-small cell lung carcinoma."

Answered by AI

To what extent is participation in this clinical trial being observed?

"Indeed, clinicaltrials.gov verifies that this medical study is in the process of recruiting participants. It was first posted on October 2nd 2019 and its most recent update occurred on August 2nd 2022. 40 patients are needed to complete enrollment at a single centre."

Answered by AI

Is this the inaugural iteration of this clinical experiment?

"Research into 89Zr-DFO-Atezolizumab began in 2008 with a clinical trial funded by Hoffmann La Roche. After positive outcomes from the first study of 720, this drug was granted Phase 2 approval and is now being evaluated in 348 studies located across 74 different nations."

Answered by AI

Are individuals currently being accepted to participate in this research?

"According to clinicaltrials.gov, this medical study is currently in recruitment mode. It was initially posted on October 2nd 2019 and the last update came on August 2nd 2022."

Answered by AI

Recent research and studies

Clinical Cancer ResearchJournal

Immunopet Imaging with 89zr-labeled Atezolizumab Enables in Vivo Evaluation of PD-L1 in Tumorgraft Models of Renal Cell Carcinoma

Mulgaonkar, Aditi, Roy Elias, Layton Woolford, Bing Guan, Kien Nham, Payal Kapur, Alana Christie, et al.. 2022. “Immunopet Imaging with 89zr-labeled Atezolizumab Enables in Vivo Evaluation of PD-L1 in Tumorgraft Models of Renal Cell Carcinoma”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-22-1547.

clinicaltrials.govStudy

89Zr-DFO-Atezolizumab ImmunoPET/CT in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma

James Brugarolas 2019. "89Zr-DFO-Atezolizumab ImmunoPET/CT in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04006522.

All > Metastatic Renal Cell Carcinoma > Renal Cell Carcinoma