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 | Not Yet Recruiting

• 2 other identifiers: HBED-CC2022-PUMCH-B-070
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

[68Ga]Ga-HBED-CC-DiAsp; PET/CT; glomerular filtration rate; partial nephrectomy

Outcome Measures

Primary Outcomes (1)

• glomerular filtration rate

  From enrollment to the end of examination at 6 weeks

Study Arms (2)

Patients planned for partial nephrectomy due to renal tumors

OTHER

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

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

OTHER

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.

Interventions

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

Patients planned for partial nephrectomy due to renal tumors

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.

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

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Luo Yaping: lead
• Peking Union Medical College Hospital: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Yaping Luo, MD

CONTACT

86-010-69154716; luoyaping@live.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor (M.D.), Chief Physician, Professor, Assistant Director

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: July 1, 2025
• Primary Completion: October 20, 2025
• Study Completion: November 10, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)