Clinical trial · Interventional
The Study on the Effectiveness of [68Ga]Ga-HBED-CC-DiAsp PET/CT in Calculating GFR and Predicting Residual Renal Function After Partial Nephrectomy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glomerular Filtration Rate | — | UNRESOLVED | — |
| Kidney Neoplasms / Surgery | Kidney Neoplasm | PROBABILISTIC | 0.70 |
| Positron-Emission Tomography(PET) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 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 | — | UNRESOLVED |
| GFR will be measured using three methods at two weeks before surgery and four ± one week after surgery | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Patients planned for partial nephrectomy due to renal tumors
- interventionNames
- Diagnostic Test: GFR will be measured using three methods at two weeks before surgery and four ± one week after surgery
- type
- OTHER
- label
- Subjects with varying levels of renal function and no history of renal tumors
- interventionNames
- 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)
- measure
- glomerular filtration rate
- timeFrame
- From enrollment to the end of examination at 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 88 Years
Show eligibility criteria text
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.
References
Publications (6)
- RESULTShi 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
- RESULTRathi 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
- RESULTMurray 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
- RESULTHofman 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
- RESULTHofman 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
- RESULTGates 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