Assessment of Renal Microcirculation With Rubidium Positron Emission Tomography

Matthieu Pelletier-Galarneau, MD MSc30 enrolled

Overview

The aim of this study is to demonstrate that positron emission tomography imaging with Rubidium-82 (radioactive tracer) can non-invasively detect and quantify changes in renal blood flow (renal perfusion) and renal vascular resistance in both healthy subjects and patients with renal insufficiency. Ultimately, the results of this study will contribute to a better understanding of the role of positron emission imaging in the evaluation of patients with renal diseases.

2\. Hypothesis 1. We hypothesize that RBF assessed with rubidium PET is on average lower in patients with CKD. To test our hypothesis, RBF of patients with CKD and coronary artery disease (CAD) risk factors, a population characterized by renal microvascular rarefaction, will be compared to RBF of healthy controls. 2. We hypothesize that RVR assessed with rubidium PET correlates with echographic measurements of renal resistance index (RI), the current non-invasive method of choice. 3. We hypothesize that RBF quantification with rubidium PET is technically reproducible, meaning that the variation on the measurements of RBF purely attributable to technical factors (camera, positioning, tracer injection, etc.) is relatively small. To test this hypothesis, two PET scans will be acquired within a short time period. 3\. Objectives and Endpoints 3.1. Primary Objective 1\) To compare RBF of patients with CKD and CAD risk factors to healthy controls 3.2. Secondary Objectives 1. To compare RVR of patients with CKD and CAD risk factors to healthy controls 2. To evaluate the correlation between RVR measured with PET to renal RI as measured with echography 3. To evaluate the repeatability and reproducibility of in vivo measurements of RBF and RVR

Study Type

OBSERVATIONAL

Enrollment

Conditions

Renal Microcirculation With Rubidium Positron Emission Tomography

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Control Group 1. Age ≥ 18 years and \< 80 years 2. Signed informed consent 3. No medical history of renal disease CKD Group 1. Age ≥ 18 years and \< 80 years 2. Signed informed consent 3. GFR between 30 and 45 mL/min/1.73m2 measured within the last 3 months 4. At least two cardiovascular disease risk factors such as hypertension, smoking, diabetes, obesity, and dyslipidemia Exclusion Criteria: Control Group 1. Hypertension 2. Diabetes 3. Dyslipidemia 4. Active smoking within the last 12 month 5. Left ventricular ejection fraction \<45% 6. BMI \>45 kg/m2 7. Severe aortic stenosis CKD Group 1. Left ventricular ejection fraction \<45% 2. BMI \>45 kg/m2 3. Severe aortic stenosis 4. Changes in medical therapy within the last 4 weeks 5. Documented renal artery stenosis 6. Known structural cause of CKD including polycystic kidney disease, obstruction, or other post-renal causes 7. Pregnancy or breastfeeding 8. Renal failure requiring dialysis within the last 90 days

Locations (1)

Montreal Heart Institute

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Renal blood flow in units of mL/min/100g

Average difference of RBF between healthy controls and CKD participants

Time frame: 1 day

Secondary Outcomes

Renal vascular resistance in units of mmHg/mL/min/100g

Average difference of RVR between healthy controls and CKD participants

Time frame: 1 day

Correlation between renal vascular resistance measured with PET and measured with echography

Correlation coefficient between RBF vs echographic measurements of renal RI

Time frame: Up to 4 weeks

Coefficient of repeatability of renal blood flow

Coefficient of repeatability, coefficient of variation, and correlation between repeated measurements

Time frame: 1 day

Data from ClinicalTrials.gov

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