Magnetic ResonanceNCT01239615
Test-retest Stability of MR-parameters. A Neuroimaging Pilot-study in Healthy Volunteers
An observational study of Magnetic Resonance, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Aim: To study the stability of brain MR-scanning parameters (blood-flow, microstructure, volume, metabolism) over 1 week in health volunteers. Hypothesis: MR-scanning parameters are stable over 1 week in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Magnetic Resonance
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2011to Jan 2012
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy volunteers
Who may be able to join
- age 18-65
- oral and written consent
Who cannot join
- intracranial disease
- previous intracranial surgery
- magnetic implant or magnetic foreign body
- claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Test-retest Stability of MR-parameters. A Neuroimaging Pilot-study in Healthy Volunteer
Aim: To study the stability of brain MR-scanning parameters (blood-flow, microstructure, volume, metabolism) over 1 week in health volunteers.
Hypothesis: MR-scanning parameters are stable over 1 week in healthy volunteers
- Conditions
- Magnetic Resonance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
cortical volume/thickness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic ResonanceStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Søren Dinesen Østergaard, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239615
- Sponsor's protocol ID
- VEK-20100061
- Status last verified
- Oct 2015
- First submitted
- 10 Nov 2010
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test-retest Stability of MR-parameters. A Neuroimaging Pilot-study in Healthy Volunteer
- ClinicalTrials.gov ID
- NCT01239615
- Acronym / sponsor ID
- VEK-20100061
- Conditions
- Magnetic Resonance
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 11 Nov 2010 (estimated)
- 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.
Aim: To study the stability of brain MR-scanning parameters (blood-flow, microstructure, volume, metabolism) over 1 week in health volunteers.
Hypothesis: MR-scanning parameters are stable over 1 week in healthy volunteers
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy volunteers
Key inclusion criteria (2 listed)
- age 18-65
- oral and written consent
Key exclusion criteria (4 listed)
- intracranial disease
- previous intracranial surgery
- magnetic implant or magnetic foreign body
- claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cortical volume/thickness
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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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 Magnetic Resonance, run by Aarhus University Hospital 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 4 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: withdrawn, as of the sponsor's last update on 14 Oct 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
cortical volume/thickness. 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 14 Oct 2015.