Study Comparing a New PET/CT Scan with Standard CT for Detecting Recurrent Kidney Cancer After Surgery

Sponsor: Jonsson Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06447103

Provider View

This clinical trial is testing a new type of PET/CT scan using a special tracer to see if it can better detect returning kidney cancer after surgery compared to the standard CT scan.

Patient Parameters

Program Overview

This study is exploring whether a new PET/CT scan using a tracer called 89Zr-DFO-GmAb can more effectively find returning clear cell kidney cancer after surgery compared to the usual contrast-enhanced CT scan. The new scan uses a tracer that attaches to a protein on kidney cancer cells, potentially making it easier to spot small or hidden tumors. The study aims to see if this new method is safe and more effective in detecting cancer recurrence.

Description

PRIMARY OBJECTIVE:

  • To compare how well the new PET/CT scan with 89Zr-DFO-GmAb detects cancer compared to the standard CT scan after surgery.

SECONDARY OBJECTIVES:

  • To ensure the safety of the new PET/CT scan in patients at risk of cancer returning after kidney surgery.
  • To compare how accurately the new PET/CT scan predicts cancer presence compared to other methods like biopsy or other imaging tests.
  • To assess how long patients remain cancer-free based on the new PET/CT scan results.

EXPLORATORY OBJECTIVES:

  • To see if the amount of a specific protein in the tumor correlates with the new scan results.
  • To find the best tracer level for detecting cancer spread after surgery.
  • To evaluate if certain genetic markers from the tumor predict cancer-free survival.
  • To see if blood tests for cancer DNA match the new scan results or predict cancer-free survival.

OUTLINE:

Patients will receive the tracer 89Zr-DFO-GmAb through an IV and undergo both the new PET/CT scan and the standard CT scan. Blood samples will be collected, and additional scans may be done if needed. Follow-up visits will occur at 8, 16, and 24 months after the study.

Eligibility Criteria

Inclusion Criteria

  • Age 18 or older.
  • Confirmed diagnosis of clear cell kidney cancer.
  • Completed surgery to remove the primary tumor and any metastases, with no evidence of disease.
  • Surgery performed 4-16 weeks before planned imaging.
  • High risk of cancer returning based on specific medical criteria.
  • Negative pregnancy test for women of childbearing potential.
  • Agree to use effective contraception for at least 42 days after receiving the tracer.
  • Able to lie still and flat for the imaging procedure.

Exclusion Criteria

  • Unable to provide written consent.
  • Evidence of remaining cancer or known metastasis at the time of the scan.
  • Previous imaging to confirm disease status.
  • Untreated non-kidney cancer, except for low-risk prostate or non-melanoma skin cancer.
  • Prior treated cancer that is not in complete remission or has required treatment in the past 3 years.
  • Allergy to CT contrast agents or poor kidney function.
  • Recent use of certain cancer treatments or experimental drugs.
  • Pregnant or breastfeeding women.
  • Allergy to the tracer used in the study.
  • Unable to lie still and flat for the imaging procedure.

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