Evaluation of the Performance of Glomerular Filtration Rate Measurement Using CT Urography in Patients With a GFR Below 60 mL/Min/1.73 m²

Официальное название

Evaluation of the Performance of Glomerular Filtration Rate Measurement Using CT Urography in Patients With Chronic Kidney Disease

Обзор

Glomerular filtration rate (GFR), which is the main biomarker used in clinical practice to assess kidney function, is usually estimated from the serum concentration of endogenous markers such as creatinine and/or cystatin C. GFR estimation equations all share the disadvantage of imperfect accuracy due to non-GFR-related determinants of creatinine and cystatin C. When knowing the exact GFR value is necessary for clinical decision-making, measurement by clearance of an exogenous tracer is required. Various tracers are available, some of which are radioactive tracers (99mTc-DTPA and 51Cr-EDTA), while others are iodinated contrast agents (iohexol, iothalamate). GFR measurement procedures are time-consuming and require significant human resources (4 to 5 hours, or even 24 hours for plasma clearances at very low GFR values).Urinary clearance methods may be inaccurate in cases of inadequate voiding. Plasma clearance results may be inaccurate in cases of increased (overestimation) or decreased (underestimation) extracellular volume, low GFR (unless late sampling is performed), or glomerular hyperfiltration. Measuring tracers requires either warm labs for measuring radioactive markers or labs with HPLC (High Performance Liquid Chromatography) chains for iohexol, which are part of an external quality assurance program. The complexity and/or length of GFR measurement procedures, their cost, and laboratory constraints explain why measured GFR is underused in routine clinical practice. There is a critical need to develop GFR measurement methods that are simpler to implement, reliable across the entire GFR spectrum, and widely available. We have demonstrated that it is possible to measure GFR using 4-phase CT urography performed as part of the care of living kidney donor candidates (healthy individuals with normal GFR). The examination takes 10 minutes, requires no biological sampling, and is not subject to potential inaccuracies due to sodium overload or poor bladder emptying.

Подробное описание

Objective: To assess whether GFR measurement using 4-phase CT urography is reliable in patients with GFR below 60 ml/min/1.73 m², as compared with iohexol clearance (reference method): - Unbiased (mean difference between CT-measured GFR and iohexol clearance not different from zero). - and accurate: at least 50% and 80% of GFR values measured by CT urography within 10% and 20% of biological clearance values for iohexol clearance.

Method: Single-center interventional study. After performing a 4-phase CT urography (or 3-phase CT scan, with the addition of a 4th phase for research purposes), performed for clinical indications as part of the patient's care, and using iohexol as a contrast agent, patients will undergo a biological measurement of iohexol clearance, based on serum and urine samples taken over 4 periods of 1 hour, between 3 and 7 hours after the CT scan. No iohexol will be reinjected to measure GFR. The CT scan images will be segmented by the investigator to determine the CT-measured GFR.

The inclusion criteria are: - Patients older than 18 years of age - Having given written consent to participate in the study. - Patient referred to the medical imaging department of the Henri Mondor University Hospital for a 3-phase or 4-phase abdominal CT scan. - With an estimated GFR according to CKD-EPIcreat2009 \< 60 ml/min/1.73m² - Hospitalized or outpatient. - Affiliated with French national health insurance.

The exclusion criteria are: - Patients with hip implants, due to artifacts that make quantification of the contrast agent in the bladder unreliable. - Lack of health insurance - Patients under legal protection.

Вмешательства

• Другое Glomerular Filtration Rate measurement with iohexol clearance
  After performing a 4-phase CT urography (or 3-phase CT scan, with the addition of a 4th phase for research purposes), performed for clinical indications as part of the patient's care, and using iohexol as a contrast agent, patients will undergo a biological measurement of iohexol clearance, based on serum and urine samples taken over 4 periods of 1 hour, between 3 and 7 hours after the CT scan. No iohexol will be reinjected to measure GFR. The CT scan images will be segmented by the investigator

Первичные конечные точки

• Assessment of the Reliability of GFR Measurement by 4-Phase CT Urography Compared to Iohexol Clearance [Срок оценки: Day 1]

Вторичные конечные точки (3)

• Reliability Assessment of GFR Estimation Using Creatinine and/or Cystatin C Compared to Iohexol Clearance [Срок оценки: Day 1]
• Reliability of Hybrid GFR (Mean of CT-Measured and Creatinine/Cystatin C Estimated GFR) [Срок оценки: Day 1]
• Reliability of CT-Measured GFR Across Patient Subgroups Defined by Estimated GFR Ranges [Срок оценки: Day 1]

Критерии участия

Критерии включения

• Patients older than 18 years of age
• Having given written consent to participate in the study
• Patient referred to the medical imaging department of the Henri Mondor University Hospital for a 3-phase or 4-phase abdominal CT scan
• With an estimated GFR according to CKD-EPIcreat2009 < 60 ml/min/1.73m²
• Hospitalized or outpatient
• Affiliated with French national health insurance

Критерии исключения

• Patients with hip implants, due to artifacts that make quantification of the contrast agent in the bladder unreliable
• Lack of health insurance
• Patients under legal protection.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 1 центр

• Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - Créteil — Créteil

Идентификаторы

NCT: NCT07042698 · APHP250438

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗