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

Официальное название

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

Обзор

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.

Подробное описание

\[68Ga\]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.

Вмешательства

• Диагностический тест 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
• Диагностический тест 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.

Первичные конечные точки

• glomerular filtration rate [Срок оценки: From enrollment to the end of examination at 6 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• Peking Union Medical College Hospital — Пекин

Публикации

• Shi S, Zhang L, Wu Z, Zhang A, Hong H, Choi SR, Zhu L, Kung HF. [68Ga]Ga-HBED-CC-DiAsp: A new renal function imaging agent. Nucl Med Biol. 2020 Mar-Apr;82-83:17-24. doi: 10.1016/j.nucmedbio.2019.12.005. Epub 2019 Dec 16. PMID 31869735
• Rathi N, Attawettayanon W, Kazama A, Yasuda Y, Munoz-Lopez C, Lewis K, Maina E, Wood A, Palacios DA, Li J, Abdallah N, Weight CJ, Eltemamy M, Krishnamurthi V, Abouassaly R, Campbell SC. Practical Prediction of New Baseline Renal Function After Partial Nephrectomy. Ann Surg Oncol. 2024 Feb;31(2):1402-1409. doi: 10.1245/s10434-023-14540-x. Epub 2023 Nov 25. PMID 38006535
• Murray AW, Barnfield MC, Waller ML, Telford T, Peters AM. Assessment of glomerular filtration rate measurement with plasma sampling: a technical review. J Nucl Med Technol. 2013 Jun;41(2):67-75. doi: 10.2967/jnmt.113.121004. Epub 2013 May 8. PMID 23658207
• Hofman MS, Hicks RJ. Gallium-68 EDTA PET/CT for Renal Imaging. Semin Nucl Med. 2016 Sep;46(5):448-61. doi: 10.1053/j.semnuclmed.2016.04.002. PMID 27553470
• Hofman M, Binns D, Johnston V, Siva S, Thompson M, Eu P, Collins M, Hicks RJ. 68Ga-EDTA PET/CT imaging and plasma clearance for glomerular filtration rate quantification: comparison to conventional 51Cr-EDTA. J Nucl Med. 2015 Mar;56(3):405-9. doi: 10.2967/jnumed.114.147843. Epub 2015 Feb 12. PMID 25678493
• Gates GF. Computation of glomerular filtration rate with Tc-99m DTPA: an in-house computer program. J Nucl Med. 1984 May;25(5):613-8. PMID 6374072

Идентификаторы

NCT: NCT06973798 · HBED-CC · 2022-PUMCH-B-070

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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