HealthyNCT05221918
A Study to Compare CSF Flow Metrics Across Platforms
An observational study of Healthy, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to find out more about detecting movement of CSF (fluid around the brain) with MRI. Researchers are doing this research study to find out how measurements of CSF movement differ among MRI machines and how image quality is changed by reducing the scan time. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2022to 20 Feb 2023
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population will include healthy young adults, ages 18-40 years.
Who may be able to join
- A healthy volunteer will be defined as an otherwise healthy person who does not have a medical condition that affects brain function or have problems with concentration, memory, balance, or coordination.
Who cannot join
- Subjects with non-MRI compatible devices, required sedation (claustrophobia or unable to remain still for exam), or women who are pregnant will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of CSF Flow Metrics Across MRI Platforms
The purpose of this research is to find out more about detecting movement of CSF (fluid around the brain) with MRI. Researchers are doing this research study to find out how measurements of CSF movement differ among MRI machines and how image quality is changed by reducing the scan time.
- Conditions
- Healthy
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of flow metrics among scanners
Flow metrics such as average total flow will be compared among multiple MRI scanners
Measured: February -December 2022
Comparison of flow metrics between scans with and without parallel imaging
Flow metrics such as the average total flow will be compared between sequences acquired with and without acceleration techniques, including parallel imaging, for a given scanner
Measured: February -December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start14 Sep 2022
- Primary completion20 Feb 2023
- Study completion20 Feb 2023
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 Mayo ClinicThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petrice M. Cogswell, Mayo Clinic
- Investigators
- Petrice Cogswell, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221918
- Sponsor's protocol ID
- 21-002907
- Status last verified
- Sep 2024
- First submitted
- 23 Jan 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of CSF Flow Metrics Across MRI Platforms
- ClinicalTrials.gov ID
- NCT05221918
- Acronym / sponsor ID
- 21-002907
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 3 Feb 2022 (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 purpose of this research is to find out more about detecting movement of CSF (fluid around the brain) with MRI. Researchers are doing this research study to find out how measurements of CSF movement differ among MRI machines and how image quality is changed by reducing the scan time.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will include healthy young adults, ages 18-40 years.
Key inclusion criteria (1 listed)
- A healthy volunteer will be defined as an otherwise healthy person who does not have a medical condition that affects brain function or have problems with concentration, memory, balance, or coordination.
Key exclusion criteria (1 listed)
- Subjects with non-MRI compatible devices, required sedation (claustrophobia or unable to remain still for exam), or women who are pregnant will be excluded.
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
Comparison of flow metrics among scanners
Time frame: February -December 2022
Flow metrics such as average total flow will be compared among multiple MRI scanners
Comparison of flow metrics between scans with and without parallel imaging
Time frame: February -December 2022
Flow metrics such as the average total flow will be compared between sequences acquired with and without acceleration techniques, including parallel imaging, for a given scanner
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 19 Sep 2024.
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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.
Petrice Cogswell, MD, PhD principal investigator
Mayo Clinic
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 Mayo Clinic at 1 site in United States.
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 1 inclusion and 1 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 19 Sep 2024. 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 United States. 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?
Comparison of flow metrics among scanners (time frame: February -December 2022). 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 19 Sep 2024.