Study on 89Zr-DFO-Atezolizumab PET/CT Scans for Patients with Advanced or Metastatic Kidney Cancer

Sponsor: James Brugarolas

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04006522

Provider View

This clinical trial is exploring a new type of PET/CT scan using 89Zr-DFO-Atezolizumab to see if it can help predict how well patients with advanced or metastatic kidney cancer respond to immune therapy. The study involves two groups: one with patients undergoing surgery and another with patients receiving immune therapy.

Patient Parameters

Program Overview

The purpose of this study is to test a new type of PET/CT scan using 89Zr-DFO-Atezolizumab in patients with advanced or metastatic kidney cancer. The scan aims to help doctors understand how well patients might respond to immune therapy by looking at a specific protein called PD-L1 in the cancer. There are two groups in the study: one group includes patients with localized kidney cancer who will have surgery, and the other group includes patients with metastatic kidney cancer who will receive immune therapy. The study will look at how the scan results relate to the cancer's response to treatment.

Description

This study is testing a new PET/CT scan using 89Zr-DFO-Atezolizumab to see if it can help predict how well patients with kidney cancer respond to immune therapy. The scan looks at a protein called PD-L1, which is important for understanding how the cancer might react to treatment.

The study includes 40 patients divided into two groups. The first group consists of patients with high-risk localized kidney cancer who will have surgery. They will have the scan before surgery to see if it can predict the cancer's behavior. The second group includes patients with metastatic kidney cancer who will receive immune therapy. The scan will be used to see if it can predict how well the cancer responds to this treatment.

Patients will be monitored for any signs of cancer returning or progressing, and they may have additional scans if needed. The study will collect data on how patients respond to immune therapy and any side effects they experience.

The goal is to see if the 89Zr-DFO-Atezolizumab scan can provide useful information about the cancer and its response to treatment, helping doctors make better treatment decisions for patients with kidney cancer.

Eligibility Criteria

Inclusion Criteria

  • Patients with suspected kidney cancer who are scheduled for surgery or have metastatic kidney cancer confirmed by a tissue diagnosis.
  • Ability to understand and sign a consent form.
  • Must be able to lie still for a 30 to 60-minute PET/CT scan.
  • One of the following:
    • Patients with locally advanced kidney cancer scheduled for surgery and at high risk of cancer returning.
    • Patients with metastatic kidney cancer planning to receive immune therapy.
  • Women of childbearing potential must have a negative pregnancy test on the day of the scan and agree to use contraception.

Exclusion Criteria

  • History of severe allergic reactions to atezolizumab or similar medications.
  • Uncontrolled severe illness or psychiatric conditions that would prevent following the study requirements.
  • Pregnant or nursing women due to potential risks to the baby.
  • Significant autoimmune disease requiring high-dose steroids or other immunosuppressive treatments.
  • Any reason that would make immune therapy unsafe.
  • Unable to provide consent.
  • Claustrophobia or other issues preventing PET/CT scans.
  • Weigh more than 440 lbs, which is the limit for the PET/CT scanner.

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