Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT06332456
Status:
COMPLETED
Last Update Posted:
2025-07-29
First Post:
2024-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Renal Microcirculation With Rubidium Positron Emission Tomography
Sponsor:
Matthieu Pelletier-Galarneau, MD MSc
Organization:
Study Overview
Official Title:
Assessment of Renal Microcirculation With Rubidium Positron Emission Tomography: A Proof-of-Concept Study
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESIST
Brief Summary:
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.
Detailed Description:
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: