89Zr-DFO-girentuximab Expanded Access Program (EAP)

April 20, 2024 updated by: Telix Pharmaceuticals (Innovations) Pty Limited

An Expanded Access Program for the Non-invasive Detection of Clear Cell Renal Cell Carcinoma (ccRCC) in Patients With Renal Masses Utilizing 89Zirconium-labelled Girentuximab (89Zr-DFO-girentuximab)

The purpose of this Expanded Access Program (EAP) is to enable the use of 89Zr-DFO-girentuximab with positron emission tomography/computed tomography (PET/CT) imaging to non-invasively detect carbonic anhydrase 9 (CAIX)-expressing clear cell renal cell carcinoma (ccRCC) in patients with renal masses as determined by conventional imaging.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Available
        • UCLA
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Available
        • University of Florida College of Medicine Jacksonville
      • Miami, Florida, United States, 33165
        • Available
        • Biogenix Molecular
    • Indiana
      • Bloomington, Indiana, United States, 47405
        • Available
        • Indiana University
    • Michigan
      • Traverse City, Michigan, United States, 49684
        • Available
        • Munson Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Available
        • University Hospitals Cleveland Medical Center
    • Texas
      • Austin, Texas, United States, 78705
        • Available
        • Austin Radiological Association

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  1. Written and voluntarily given informed consent.
  2. Male or female ≥ 18 years of age.
  3. Imaging evidence of renal mass(es) obtained from conventional diagnostic imaging with CT or MRI (without and with contrast enhancement) based on national standards that is not older than 90 days on Day 0, and that was performed before any screening procedure.
  4. Negative urine/serum pregnancy tests in female patients of childbearing potential.
  5. Consent to practice highly effective contraception until a minimum of 42 days after IV 89Zr-DFO-girentuximab administration.

Exclusion Criteria:

  1. Renal mass known to be a metastasis of another primary tumor.
  2. Active non-renal malignancy requiring therapy during and up to EOT visit.
  3. Radiotherapy or immunotherapy within 4 weeks (28 days) prior to the planned administration of 89Zr-DFO-girentuximab or continuing adverse effects (> grade 1 using Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) from such therapy.
  4. Planned antineoplastic therapies (for the period between IV administration of 89Zr-DFO-girentuximab and imaging).
  5. Previous administration of any radionuclide within 10 of its half-lives before Day 0.
  6. Serious non-malignant disease (e.g., psychiatric, infectious, autoimmune, or metabolic), that may interfere with the objectives of the program or with the safety or compliance of the subject, as judged by the Investigator.
  7. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the program.
  8. Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-DFO-girentuximab.
  9. Women who are pregnant or breastfeeding.
  10. Known hypersensitivity to girentuximab or DFO (desferoxamine).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Telix Pharmaceuticals (Innovations) Pty Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

October 12, 2023

First Submitted That Met QC Criteria

October 12, 2023

First Posted (Actual)

October 19, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 20, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 89Zr-TLX250-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Clear Cell Renal Cell Carcinoma

Clinical Trials on 89Zr-DFO-girentuximab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe