89Zr-DFO-girentuximab Expanded Access Program (EAP)
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)
1 other identifier
expanded_access
N/A
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2023
CompletedFirst Posted
Study publicly available on registry
October 19, 2023
CompletedJuly 8, 2025
July 1, 2025
October 12, 2023
July 7, 2025
Conditions
Keywords
Interventions
Single IV administration on Day 0, followed by diagnostic scan on Day 5 +/- 2 days.
Eligibility Criteria
You may qualify if:
- Written and voluntarily given informed consent.
- Male or female ≥ 18 years of age.
- 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.
- Negative urine/serum pregnancy tests in female patients of childbearing potential.
- Consent to practice highly effective contraception until a minimum of 42 days after IV 89Zr-DFO-girentuximab administration.
You may not qualify if:
- Renal mass known to be a metastasis of another primary tumor.
- Active non-renal malignancy requiring therapy during and up to EOT visit.
- 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.
- Planned antineoplastic therapies (for the period between IV administration of 89Zr-DFO-girentuximab and imaging).
- Previous administration of any radionuclide within 10 of its half-lives before Day 0.
- 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.
- Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the program.
- Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-DFO-girentuximab.
- Women who are pregnant or breastfeeding.
- Known hypersensitivity to girentuximab or DFO (desferoxamine).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Arkansas Urology
Little Rock, Arkansas, 72211, United States
UCLA
Los Angeles, California, 90095, United States
University of Florida College of Medicine Jacksonville
Jacksonville, Florida, 32209, United States
Biogenix Molecular
Miami, Florida, 33165, United States
Sarasota Memorial Health Care System
Sarasota, Florida, 34243, United States
Indiana University
Bloomington, Indiana, 47405, United States
Kansas University Medical Center
Kansas City, Kansas, 66103, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Xcancer
Omaha, Nebraska, 68130, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Kettering Health Main Campus
Kettering, Ohio, 45429, United States
Urology Associates, PC
Nashville, Tennessee, 37209, United States
Austin Radiological Association
Austin, Texas, 78705, United States
UT Southwestern
Dallas, Texas, 75390, United States
Urology San Antonio
San Antonio, Texas, 78229, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2023
First Posted
October 19, 2023
Last Updated
July 8, 2025
Record last verified: 2025-07