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NCT Number: NCT06973798

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.

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Key information

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

[68Ga]Ga-HBED-CC-DiAsp PET/CT Imaging: After intravenous injection of [68Ga]Ga-HBED-CC-DiAsp, a Scout scan, low-dose CT scan, and a 30-minute dynamic PET scan are performed sequentially. The functional renal cortex is delineated in the first PET frame showing the radiotracer filling the renal cortex. A functional renal cortex radioactivity concentration function is constructed based on a compartment model with GFR as a parameter and time as an independent variable. This function is then fitted to the time-activity curve (TAC) of the functional renal cortex to obtain the GFR value.

Gates Method and 99mTc-DTPA Dual Plasma Method: After intravenous injection of 99mTc-DTPA, renal blood flow functional imaging is performed immediately, collecting time-activity curves from both renal areas. GFR is calculated based on the percentage (%ID) of bilateral renal radiotracer uptake relative to the injected dose. Blood samples of 10 ml are collected from the contralateral forearm at 1 hour and 2 hours post-injection, and GFR is calculated using the dual plasma method.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years;
  • Written informed consent obtained.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. glomerular filtration rate

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yaping Luo, MD

CONTACT

[email protected]

86-010-69154716

Sponsors and collaborators

Lead sponsor

Luo Yaping

Other

Collaborators

  • Peking Union Medical College Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 15, 2025
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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