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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-88
SponsorLuo Yaping

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

Qualifiers

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

Treatments tested in this trial

  • GFR 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.

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Luo Yaping

Lead sponsor

Peking Union Medical College Hospital

Sponsor institution

Peking Union Medical College Hospital

Collaborator