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

Part of paid clinical trials in Dallas, Texas.

Sponsor
James Brugarolas
Study ID
NCT04006522
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 89Zr-DFO-Atezolizumab — DRUG
    89Zr-DFO-Atezolizumab infusion
  • Positron Emission Tomography/Computed Tomography — PROCEDURE
    PET/CT scan 7 days (± 1 day) after infusion of 89Zr-DFO-Atezolizumab.

Study Details

This is an exploratory clinical trial to assess the potential of 89Zr-DFO-Atezolizumab Positron Emission Tomography/Computed Tomography (PET/CT) scans in patients with locally advanced or metastatic renal cell carcinoma (RCC). This open label, nontherapeutic trial will test the correlation of 89Zr-DFO-Atezolizumab immunoPET/CT with programmed death-ligand 1 (PD-L1) expression and the response to immune checkpoint inhibitor therapy in patients with RCC. There will be two cohorts, one made up of patients with localized RCC who will undergo 89Zr-DFO-Atezolizumab PET/CT prior to nephrectomy and a second cohort of patients with metastatic RCC who will undergo 89Zr-DFO-Atezolizumab PET/CT prior to treatment with an immune checkpoint inhibitor.

Key Dates

Start date
Oct 2, 2019
Status verified
Apr 2026
Primary completion
Oct 7, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
46 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Cohort 1
    Patients with Localized RCC prior to nephrectomy.
  • Experimental: Cohort 2
    Patients with Unresectable/Metastatic RCC prior to treatment with an immune checkpoint inhibitor.

Primary Outcome Measure

Correlation between 89Zr-DFO-Atezolizumab and PD-L1 [ Time Frame: Up to 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CenterDallasTexas75390-

Find similar trials in Dallas, TX

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
UT Southwestern Medical Center· Dallas, TX

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