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

NCT06973798 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-15

No results posted yet for this study

Summary

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.

Conditions

  • Kidney Neoplasms / Surgery
  • Glomerular Filtration Rate
  • Positron-Emission Tomography(PET)

Interventions

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 at two weeks before surgery and four ± one week after surgery

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.

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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER

  • Luo Yaping

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
88 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2025-10-20
Completion
2025-11-10

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06973798 on ClinicalTrials.gov