The Study on the Effectiveness of [68Ga]Ga-HBED-CC-DiAsp PET/CT in Calculating GFR and Predicting Residual Renal Function After Partial Nephrectomy

In subjects with different levels of renal function and no history of renal tumors, GFR is measured using \[68Ga\]Ga-HBED-CC-DiAsp PET/CT, the Gates method, and the 99mTc-DTPA dual plasma method. The consistency between the three methods is analyzed using intra-class correlation coefficient (ICC), concordance correlation coefficient (CCC), and Bland-Altman analysis. In patients scheduled for partial nephrectomy due to renal tumors, GFR is measured using the three methods within 2 weeks before surgery and 4±1 weeks post-surgery. The percentage of postoperative residual renal function (postoperative GFR/preoperative GFR × 100%, hereafter referred to as RRF%) is calculated for each method. By comparing and overlaying preoperative and postoperative PET/CT images, the resected renal area can be delineated on the preoperative PET/CT image. Based on the preoperative PET/CT and the delineated surgical area, a predictive value for postoperative GFR is calculated to obtain the predicted RRF%. A consistency analysis is then performed between the predicted RRF% and the actual RRF% measured by the three methods, using ICC, CCC, and Bland-Altman analysis to evaluate the efficacy of \[68Ga\]Ga-HBED-CC-DiAsp PET/CT in predicting residual renal function after partial nephrectomy.

NCT Number	NCT06973798
Lead Sponsor	Luo Yaping Collaborators: Peking Union Medical College Hospital
Conditions	Kidney Neoplasms / Surgery, Glomerular Filtration Rate, Positron-Emission Tomography(PET)
Enrollment	40 participants
Start Date	2025-07-01
Primary Completion	2025-10-20 (estimated)
Study Completion	2025-11-10 (estimated)
Updated on ClinicalTrials.gov	2025-05-15