Renal Functional Magnetic Resonance Imaging in Healthy Persons - Reproducibility and Impact of Stress

The main purpose of the study is to describe the applicability and reproducibility of functional MRI scans of the kidneys in healthy participants. Furthermore, the study examines to what extent physiological stress caused by lying in a scanner affects the renal perfusion and thus the reproducibility

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Diagnostic test: Functional MRI scan

Detailed Description

2 groups of 10 healthy participants each are included. 1 group aged 18 to 40 and a group of participants above 60 years of age.

The functional MRI sequences are performed consecutively in a protocol set up on a 1,5 T MRI scanner.

In totl, 3 identical scans are being performed. 2 scans on day 1 followed by another scan 1-2 weeks later. Before and after each scan, cortisol and copeptin is controlled in a blood sample to quantify the level of physiological stress.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Denmark
  • Region Midt
    • Aarhus, Region Midt, Denmark, 8200
      • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy participants

Description

Inclusion Criteria:

• Age between 18 and 40
• Age of 60 or above

Exclusion Criteria:

• Known kidney or cardiovascular disease
• Medicine of any kind, that must be taken on days of scanning
• MRi incompatible implants or other contraindications to MRi
• Claustrophobia
• Not being able to lie still in an hour
• Body weight above 110 kg or waist circumference above 95 cm
• Pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy participants aged 18 to 40; 3 identical functional MRI scans. Blood samples to quantify level of physiological stress are taken before and after each scan.	Diagnostic test: Functional MRI scan; Functional MRI scan: Phase contrast, BOLD, Arterial Spin Labeling, Diffusion weighted MRI, T1 mapping, T1rho mapping
Healthy participants aged 60 and above; 3 identical functional MRI scans. Blood samples to quantify level of physiological stress are taken before and after each scan.	Diagnostic test: Functional MRI scan; Functional MRI scan: Phase contrast, BOLD, Arterial Spin Labeling, Diffusion weighted MRI, T1 mapping, T1rho mapping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproducibility	Reproducibility as a coefficient of variation	Results from scans performed with an interval of 1 to 2 weeks are compared
Physiological stress	Quantified by level of cortisol and copeptin in blood samples.	Results from scans performed with an interval of 1 to 2 weeks are compared

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): March 27, 2021
• Study Completion (Actual): March 27, 2021

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 7, 2020

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 76158

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No