HealthyNCT04656314
Renal Functional Magnetic Resonance Imaging in Healthy Persons - Reproducibility and Impact of Stress
An observational study of Healthy, run by University of Aarhus at 1 site in Denmark.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Functional MRI scan
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jan 2021to 27 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy participants
Who may be able to join
- Age between 18 and 40
- Age of 60 or above
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Healthy
- Being tested
- Functional MRI scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional MRI scanDiagnostic test
Functional MRI scan: Phase contrast, BOLD, Arterial Spin Labeling, Diffusion weighted MRI, T1 mapping, T1rho mapping
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Functional MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility
Reproducibility as a coefficient of variation
Measured: 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.
Measured: Results from scans performed with an interval of 1 to 2 weeks are compared
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start15 Jan 2021
- Primary completion27 Mar 2021
- Study completion27 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656314
- Sponsor's protocol ID
- 76158
- Status last verified
- Nov 2020
- First submitted
- 30 Nov 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Functional Magnetic Resonance Imaging in Healthy Persons - Reproducibility and Impact of Stress
- ClinicalTrials.gov ID
- NCT04656314
- Acronym / sponsor ID
- 76158
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 27 Mar 2021 (actual)
- Study completion
- 27 Mar 2021 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy participants aged 18 to 40 | – | Diagnostic Test: Functional MRI scan3 identical functional MRI scans. Blood samples to quantify level of physiological stress are taken before and after each scan. |
| Healthy participants aged 60 and above | – | Diagnostic Test: Functional MRI scan3 identical functional MRI scans. Blood samples to quantify level of physiological stress are taken before and after each scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy participants
Key inclusion criteria (2 listed)
- Age between 18 and 40
- Age of 60 or above
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional MRI scanFunctional MRI scan: Phase contrast, BOLD, Arterial Spin Labeling, Diffusion weighted MRI, T1 mapping, T1rho mapping | Diagnostic test | Healthy participants aged 18 to 40, Healthy participants aged 60 and above |
Primary outcome
Reproducibility
Time frame: Results from scans performed with an interval of 1 to 2 weeks are compared
Reproducibility as a coefficient of variation
Physiological stress
Time frame: Results from scans performed with an interval of 1 to 2 weeks are compared
Quantified by level of cortisol and copeptin in blood samples.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducibility (time frame: Results from scans performed with an interval of 1 to 2 weeks are compared). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.