Expanded Access Program for 89Zr-DFO-girentuximab to Detect Kidney Cancer

Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06090331

Provider View

This program allows patients with kidney masses to use a special imaging technique to detect a type of kidney cancer called clear cell renal cell carcinoma (ccRCC) without needing invasive procedures.

Patient Parameters

Program Overview

The Expanded Access Program (EAP) is designed to help patients with kidney masses by using a special imaging method called 89Zr-DFO-girentuximab with PET/CT scans. This method helps doctors see if the kidney mass is a type of cancer known as clear cell renal cell carcinoma (ccRCC) by detecting a specific protein called carbonic anhydrase 9 (CAIX). This approach is non-invasive, meaning it doesn't require surgery or other procedures that go inside the body.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Must be 18 years or older.
  • Must have a kidney mass seen on recent CT or MRI scans (within the last 90 days) that meets national standards.
  • Women who can become pregnant must have a negative pregnancy test.
  • Must agree to use effective birth control until at least 42 days after receiving the 89Zr-DFO-girentuximab injection.

Exclusion Criteria

  • Kidney mass that is known to be from another type of cancer.
  • Currently have another active cancer that needs treatment.
  • Have had radiation or immune therapy within the last 4 weeks, or still have side effects from such treatments.
  • Plan to start cancer treatments between receiving the injection and the imaging.
  • Have received any radioactive treatment recently.
  • Have a serious non-cancer illness that could affect participation.
  • Have mental health issues that affect understanding or following the program.
  • Have taken part in other experimental drug studies recently.
  • Are pregnant or breastfeeding.
  • Have allergies to the substances used in the imaging method.

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