NCT04656314

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2021

Completed
Last Updated

April 8, 2021

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

November 30, 2020

Last Update Submit

April 6, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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

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

Interventions

Functional MRI scanDIAGNOSTIC_TEST

Functional MRI scan: Phase contrast, BOLD, Arterial Spin Labeling, Diffusion weighted MRI, T1 mapping, T1rho mapping

Healthy participants aged 18 to 40Healthy participants aged 60 and above

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy participants

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, Region Midt, 8200, Denmark

Location

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2020

First Posted

December 7, 2020

Study Start

January 15, 2021

Primary Completion

March 27, 2021

Study Completion

March 27, 2021

Last Updated

April 8, 2021

Record last verified: 2020-11

Locations

DK(1)