A prospective, open-label, phase 2 study to explore CAIX expression through 89Zirconium-labelled girentuximab deferoxamine (89Zr-girentuximab) PET/CT imaging in patients with solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
11
On Day 0, participants will receive a single administration of 89Zr-girentuximab (37 Megabecquerel (MBq) \[1mCi\] ± 10%, containing a mass dose of 10 mg of girentuximab).
University of California, Los Angeles(UCLA)
Los Angeles, California, United States
Biogenix Molecular, LLC
Miami, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Munson Medical Center
Traverse City, Michigan, United States
University Hospitals Cleveland Medical Center (UHCMC)
Cleveland, Ohio, United States
Kettering Health Research Institute
Kettering, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Austin Radiological Association (ARA)
Austin, Texas, United States
Carilion Clinic
Roanoke, Virginia, United States
Inland Imaging
Spokane, Washington, United States
Qualitative assessment of 89Zr-girentuximab uptake within individual tumor deposits
This outcome will be evaluated on all patients by using a PET/CT machine to qualitatively assess (yes / no) the uptake of the 89Zr-girentuximab uptake within individual tumor deposits.
Time frame: Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. This assessment will be conducted throughout the patient dosing and imaging period, an average of 18 months
Quantitative assessment of 89Zr-girentuximab uptake within individual tumor deposits
This outcome will be evaluated on all patients by using a PET/CT machine to quantitatively assess the uptake of the 89Zr-girentuximab uptake within individual tumor deposits.
Time frame: Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. This assessment will be conducted throughout the patient dosing and imaging period, an average of 18 months
To evaluate safety parameter of Heart rate in patients administered with 89Zr-girentuximab
This outcome will be measured as beats per minute on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria
Time frame: Patients will be evaluated for the period up to imaging following administration of 89Zr-girentuximab, at most 7 days.
To evaluate safety parameter of blood pressure in patients administered with 89Zr-girentuximab.
This outcome will be measured as mmHg on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria
Time frame: Patients will be evaluated for the period up to imaging following administration of 89Zr-girentuximab, up to 7 days.
To evaluate safety parameter related to Liver function in patients administered 89Zr-girentuximab
This outcome will be measured on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria. Results will be assessed by number of participants with abnormal laboratory values.
Time frame: Patients will be evaluated for the period up to imaging following administration of 89Zr-girentuximab, up to 7 days.
To evaluate safety parameter related to Renal function in patients administered 89Zr-girentuximab
This outcome will be measured on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria. Results will be assessed by number of participants with abnormal laboratory values.
Time frame: Patients will be evaluated for the period up to imaging following administration of 89Zr-girentuximab, up to 7 days.
To evaluate safety parameter related to Full Blood Count in patients administered 89Zr-girentuximab
This outcome will be measured on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria. Results will be assessed by number of participants with abnormal laboratory values.
Time frame: Patients will be evaluated for the period up to imaging following administration of 89Zr-girentuximab, up to 7 days.
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