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

NO_LONGER_AVAILABLE

Conditions studied: Clear Cell Renal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT06090331

Run by

Telix Pharmaceuticals (Innovations) Pty Limited

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• Arkansas Urology — Little Rock, Arkansas, United States
• UCLA — Los Angeles, California, United States
• Stanford Urologic Cancer Program — Palo Alto, California, United States
• University of Florida College of Medicine Jacksonville — Jacksonville, Florida, United States
• Biogenix Molecular — Miami, Florida, United States
• Sarasota Memorial Health Care System — Sarasota, Florida, United States
• Indiana University — Bloomington, Indiana, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• United Theranostics — Glen Burnie, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Munson Medical Center — Traverse City, Michigan, United States
• M Health Fairview/ University of Minnesota — Minneapolis, Minnesota, United States
• Xcancer — Omaha, Nebraska, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Kettering Health Main Campus — Kettering, Ohio, United States
• Urology Associates, PC — Nashville, Tennessee, United States
• Austin Radiological Association — Austin, Texas, United States
• UT Southwestern — Dallas, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Urology San Antonio — San Antonio, Texas, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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