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)
Investigational Study on Non-Invasive Detection of Kidney Cancer
Mark Tann, MD
Primary Investigator
Brief description of study
- The aim 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 noninvasively detect carbonic anhydrase 9 (CAIX)-expressing clear cell renal cell carcinoma (ccRCC) in patients with renal masses as determined by conventional imaging.
- Generate additional safety and real-world data in understanding how 89Zr-DFO-girentuximab will be used in clinical practice . Within the EAP, additional data will be collected to support the safety and efficacy data obtained within previous clinical studies
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
- A single administration of 37 MBq (±10%) 89Zr-DFO-girentuximab containing a mass dose of 10 mg of girentuximab
- Route of administration Intravenous (IV) injection
- Duration of treatment Single diagnostic administration, followed by a PET/CT diagnostic scan on Day 5 ± 2 post administration
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Clear Cell Renal Cell Carcinoma, Cancer
-
Age: 18 years - 100 years
-
Gender: All
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 as defined in the Schedule of Assessments
(SOA) (see Table 1).
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)
This study investigates the use of an investigational medication with imaging to find kidney cancer in patients with kidney masses. The purpose is to see if this method can detect a specific type of kidney cancer called clear cell renal cell carcinoma (ccRCC). This type of cancer is known to express a protein called CAIX, which can be seen using special imaging techniques.
Participants will receive a single dose of the investigational medication through an IV. After a few days, they will have a PET/CT scan to see if the cancer can be detected. This study is part of an Expanded Access Program, which means it is mainly for gathering more information on safety and how the medication works in real-life settings.
- Who can participate: Adults aged 18 and older with imaging evidence of a kidney mass can participate. Women must not be pregnant or breastfeeding, and all participants must agree to use effective birth control. Informed consent is required. People with certain other health conditions or treatments may not be eligible.
- Study details: Participants will receive one IV dose of the investigational medication and then have a PET/CT scan a few days later. The investigational medication is given once, and the scan helps to check for cancer.
