Clinical trial NCT06090331: 89Zr-DFO-girentuximab Expanded Access Program (EAP)
Official title: 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)
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Clear Cell Renal Cell Carcinoma
Keywords: clear cell renal cell carcinoma
PET/CT imaging
89Zr-girentuximab
Lead sponsor: Telix Pharmaceuticals (Innovations) Pty Limited
Sponsor class: INDUSTRY
First posted: 2023-10-19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT

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.


Eligibility criteria: 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).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Urology
state: Arkansas
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Jacksonville
country: United States
facility: University of Florida College of Medicine Jacksonville
state: Florida
city: Miami
country: United States
facility: Biogenix Molecular
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Health Care System
state: Florida
city: Bloomington
country: United States
facility: Indiana University
state: Indiana
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Omaha
country: United States
facility: Xcancer
state: Nebraska
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Kettering
country: United States
facility: Kettering Health Main Campus
state: Ohio
city: Nashville
country: United States
facility: Urology Associates, PC
state: Tennessee
city: Austin
country: United States
facility: Austin Radiological Association
state: Texas
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
References: