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临床试验/NCT06973798
NCT06973798尚未招募不适用

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

Luo Yaping1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
glomerular filtration rate

研究概览

简要总结

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.

详细描述

[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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 88 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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.

研究组 & 干预措施

Patients planned for partial nephrectomy due to renal tumors

Other

干预措施: GFR will be measured using three methods at two weeks before surgery and four ± one week after surgery (Diagnostic Test)

Subjects with varying levels of renal function and no history of renal tumors

Other

干预措施: 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)

结局指标

主要结局

glomerular filtration rate

时间窗: From enrollment to the end of examination at 6 weeks

次要结局

未报告次要终点

研究者

发起方
Luo Yaping
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Luo Yaping

Medical Doctor (M.D.), Chief Physician, Professor, Assistant Director

Peking Union Medical College Hospital

研究点 (1)

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