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Completed

NCT Number: NCT06332456

Assessment of Renal Microcirculation With Rubidium Positron Emission Tomography

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

About this study

  • Hypothesis
  • 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.
  • We hypothesize that RVR assessed with rubidium PET correlates with echographic measurements of renal resistance index (RI), the current non-invasive method of choice.
  • 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.
  • Objectives and Endpoints 3.1. Primary Objective
  • To compare RBF of patients with CKD and CAD risk factors to healthy controls 3.2. Secondary Objectives
  • To compare RVR of patients with CKD and CAD risk factors to healthy controls
  • To evaluate the correlation between RVR measured with PET to renal RI as measured with echography
  • To evaluate the repeatability and reproducibility of in vivo measurements of RBF and RVR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Control Group

  • Age ≥ 18 years and < 80 years
  • Signed informed consent
  • No medical history of renal disease

CKD Group

  • Age ≥ 18 years and < 80 years
  • Signed informed consent
  • GFR between 30 and 45 mL/min/1.73m2 measured within the last 3 months
  • At least two cardiovascular disease risk factors such as hypertension, smoking, diabetes, obesity, and dyslipidemia

Exclusion criteria

Control Group

  • Hypertension
  • Diabetes
  • Dyslipidemia
  • Active smoking within the last 12 month
  • Left ventricular ejection fraction <45%
  • BMI >45 kg/m2
  • Severe aortic stenosis

CKD Group

  • Left ventricular ejection fraction <45%
  • BMI >45 kg/m2
  • Severe aortic stenosis
  • Changes in medical therapy within the last 4 weeks
  • Documented renal artery stenosis
  • Known structural cause of CKD including polycystic kidney disease, obstruction, or other post-renal causes
  • Pregnancy or breastfeeding
  • Renal failure requiring dialysis within the last 90 days

Treatment and study plan

Primary outcomes

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

    Time frame: 1 day

    Average difference of RBF between healthy controls and CKD participants

Secondary outcomes

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

    Time frame: 1 day

    Average difference of RVR between healthy controls and CKD participants

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

    Time frame: Up to 4 weeks

    Correlation coefficient between RBF vs echographic measurements of renal RI

  3. Coefficient of repeatability of renal blood flow

    Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

Matthieu Pelletier-Galarneau, MD MSc

Other

Registry information

Official study title

Assessment of Renal Microcirculation With Rubidium Positron Emission Tomography: A Proof-of-Concept Study

Acronym: RESIST

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2024
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.