MONDAY, Oct. 21, 2024 (HealthDay News) -- ⁸⁹Zr-labeled monoclonal antibody ([⁸⁹Zr]Zr-girentuximab) for positron emission tomography-computed tomography (PET-CT) is accurate for detecting patients with clear-cell renal cell carcinoma, according to a study published online in the October issue of The Lancet Oncology.
Brian Shuch, M.D., from the University of California Los Angeles, and colleagues conducted a multicenter, phase 3 trial at 36 research hospitals and practices across nine countries to examine [⁸⁹Zr]Zr-girentuximab PET-CT imaging for detection and characterization of clear-cell renal cell carcinoma. Three hundred patients aged 18 years or older with an indeterminate renal mass 7 cm or smaller (cT1) suspicious for clear-cell renal cell carcinoma and scheduled for nephrectomy received a single dose of [⁸⁹Zr]Zr-girentuximab intravenously followed by abdominal PET-CT imaging. Surgery was performed up to 90 days after [⁸⁹Zr]Zr-girentuximab administration.
The primary analysis included 284 of the evaluable patients. The mean sensitivity and specificity of [⁸⁹Zr]Zr-girentuximab PET-CT imaging for detection of clear-cell renal cell carcinoma was 85.5 and 87.0 percent, respectively. There were no safety signals. Most of the adverse events were not or were unlikely to be related to [⁸⁹Zr]Zr-girentuximab; 74 percent of the 261 events occurred during or after surgery. Fifty-two serious adverse events were reported in 25 patients, of which 51 occurred after surgery. No treatment-related deaths occurred.
"Imaging using [⁸⁹Zr]Zr-girentuximab has the potential to change clinical practice in renal cell carcinoma, including staging and monitoring patients at high risk and detection of distant metastasis," the authors write.
Several authors disclosed ties to biopharmaceutical companies, including Telix Pharmaceuticals, which funded the study.
Abstract/Full Text
