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

This trial accepts healthy volunteers

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

Design model

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 test

    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.

    Diagnostic test

    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
Group A: Patients planned for partial nephrectomy due to renal tumorsOther 1 intervention
Group B: Subjects with varying levels of renal function and no history of renal tumorsOther 1 intervention

Trial outcomes

Primary outcomes

1

glomerular filtration rate

Time frame
From enrollment to the end of examination at 6 weeks

Secondary outcomes

Other outcomes

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

This trial is not recruiting at the moment. You can still explore other options: