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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.
Must not have
Significant autoimmune disease requiring treatment with either prednisone (or steroid equivalent) at a dose > 10 mg/day or other immunosuppressive agents. (Replacement steroid therapy is acceptable).
Subjects unable to provide informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on high-dose steroids or other drugs for an autoimmune disease.
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I am unable to understand and give consent for my treatment.
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I do not have any severe illness or social situations that would stop me from following the study requirements.

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

Awards & Highlights

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

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

Find a Location

Who is running the clinical trial?

Orhan Kemal OzLead Sponsor
1 Previous Clinical Trials
35 Total Patients Enrolled
James BrugarolasLead Sponsor
Orhan Oz, MD, PhDPrincipal InvestigatorUT Southwestern Medical Center
James Brugarolas, MD, PhDPrincipal InvestigatorUT Southwestern Medical Center
1 Previous Clinical Trials
35 Total Patients Enrolled

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
~3 spots leftby Jul 2025
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