About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age > 18 years;
Written informed consent obtained.
Disqualifiers
Patients with claustrophobia or fear of radiation;
Women who are planning to conceive, pregnant, or breastfeeding;
Patients unable to lie flat for 30 minutes;
Patients or family members who cannot understand the conditions and objectives of the study, or who refuse to participate.
Trial design
Parallel
Treatments tested in this trial
GFR will be measured using three methods at two weeks before surgery and four ± one week after surgery
Diagnostic testGFR will be measured using three methods at two weeks before surgery and four ± one week after surgery
GFR will be measured using three methods: [68Ga]Ga-HBED-CC-DiAsp PET/CT, the Gates method, and the dual plasma sampling method with 99mTc-DTPA.
Diagnostic testGFR will be measured using three methods: \[68Ga\]Ga-HBED-CC-DiAsp PET/CT, the Gates method, and the dual plasma sampling method with 99mTc-DTPA.
Treatment groups
Trial outcomes
Primary outcomes
glomerular filtration rate
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Luo Yaping
Lead sponsor
Peking Union Medical College Hospital
Sponsor institution
Peking Union Medical College Hospital
Collaborator
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