Study WX-20-002 will confirm diagnostic efficacy and safety of a PET/CT scan using Iodine (124I) Girentuximab performed during the diagnostic work-up in patients with indeterminate cT1-renal masses.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
i.v.
David Geffen School of Medicine, UCLA
Los Angeles, California, United States
H. Lee Moffitt Cancer Center & Research Center
Tampa, Florida, United States
Lahey Clinic
Burlington, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Sensitivity and specificity of Iodine (124I) Girentuximab PET/CT scans will be compared to the threshold value of 0.70 using a two-sided exact binomial test at level 0.05.
Time frame: PET/CT imaging of the kidneys will be performed 5 (±1) days (Day 4, 5, or 6) after the Iodine (124I) Girentuximab infusion.
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Duke University Medical Center
Durham, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
MD Anderson
Houston, Texas, United States