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Trial Title:
89Zr-DFO-girentuximab Expanded Access Program (EAP)
NCT ID:
NCT06090331
Condition:
Clear Cell Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Conditions: Keywords:
clear cell renal cell carcinoma
PET/CT imaging
89Zr-girentuximab
Study type:
Expanded Access
Overall status:
Available
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
89Zr-DFO-girentuximab
Description:
Single IV administration on Day 0, followed by diagnostic scan on Day 5 +/- 2 days.
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.
Criteria for 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Locations:
Facility:
Name:
UCLA
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Available
Contact:
Last name:
Ankush Sachdeva
Phone:
310-794-3452
Email:
asachdeva@mednet.ucla.edu
Facility:
Name:
University of Florida College of Medicine Jacksonville
Address:
City:
Jacksonville
Zip:
32209
Country:
United States
Status:
Available
Contact:
Last name:
Kethandapatti Balaji
Phone:
904-244-7340
Email:
kethandapatti.balaji@jax.ufl.edu
Facility:
Name:
Biogenix Molecular
Address:
City:
Miami
Zip:
33165
Country:
United States
Status:
Available
Contact:
Last name:
Claudia Alvarez
Phone:
786-791-1799
Email:
claudia@biogenixmolecular.com
Facility:
Name:
Indiana University
Address:
City:
Bloomington
Zip:
47405
Country:
United States
Status:
Available
Contact:
Last name:
Office for Research Imaging
Phone:
317-963-7228
Email:
ori@iupui.edu
Contact backup:
Last name:
Kelly Beckman
Phone:
317-963-7049
Email:
beckman2@iu.edu
Facility:
Name:
Munson Medical Center
Address:
City:
Traverse City
Zip:
49684
Country:
United States
Status:
Available
Contact:
Last name:
David Heimburger, MD
Phone:
231-392-8400
Email:
cfcc-cancerresearch@mhc.net
Facility:
Name:
University Hospitals Cleveland Medical Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Available
Contact:
Last name:
Carmen Gray
Phone:
216-286-3014
Email:
Carmen.Gray@uhhospitals.org
Contact backup:
Last name:
Cheryl Eitman
Phone:
216-844-5393
Email:
Eitman.cheryl@uhhospitals.org
Facility:
Name:
Austin Radiological Association
Address:
City:
Austin
Zip:
78705
Country:
United States
Status:
Available
Contact:
Last name:
Shannon Wood
Phone:
512-519-3456
Email:
woods@ausrad.com
Lead sponsor:
Agency:
Telix Pharmaceuticals (Innovations) Pty Limited
Agency class:
Industry
Source:
Telix Pharmaceuticals (Innovations) Pty Limited
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06090331
