HealthyNCT04486248
Comparison of Magnetic Resonance Techniques for the Measurement of Cerebral Blood Perfusion
An observational study of Healthy, run by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 1 site in Spain.
Trial summary
In this project, we aim at implementing a te-ASL sequence and to compare it to two reference ASL sequences with a fixed PLD on healthy individuals. On the one hand, the te-ASL sequence will be compared against a 3D pCASL with a PLD of 1800 ms, as the current reference according the Consensus of the ISMRM perfusion… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 9 Oct 2019to 31 Dec 2022
- 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: Thirty (N=30) healthy individuals older than 18 years old
Who may be able to join
- To sign the study informed consent form approved by the corresponding authorities.
- Healthy men and women (older than 18 years old).
Who cannot join
- Inability or unwillingness to give written informed consent or communicate with the study staff or illiteracy.
- Any contraindication to perform brain MRI procedure (e.g. pacemaker, MRI-incompatible aneurysm clips).
Trial locations and contacts
1 site in 1 country.
About this study
In this project, we aim at implementing a te-ASL sequence and to compare it to two reference ASL sequences with a fixed PLD on healthy individuals. On the one hand, the te-ASL sequence will be compared against a 3D pCASL with a PLD of 1800 ms, as the current reference according the Consensus of the ISMRM perfusion study group and the European consortium for ASL in dementia. On the other, as the implemented te-ASL sequence will have a 2D readout, it will also be compared to a 2D pCASL ASL sequence with the same PLD, in order to be able to disentangle differences due to the dynamic PLD scheme from those arising from the different read-out schemes.
- Conditions
- Healthy
What is being measured
The primary outcome is the main question the study is designed to answer.
ASL perfusion MRI data
Quantification of cerebral blood flow
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start9 Oct 2019
- Primary completion24 Feb 2020
- Study completion31 Dec 2022
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.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486248
- Sponsor's protocol ID
- ASL/BBRC2019
- Status last verified
- Sep 2021
- First submitted
- 20 Jul 2020
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- 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 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Magnetic Resonance Techniques for the Measurement of Cerebral Blood Perfusion
- ClinicalTrials.gov ID
- NCT04486248
- Acronym / sponsor ID
- ASL/BBRC2019
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Barcelonabeta Brain Research Center, Pasqual Maragall FoundationUniversity, hospital or other
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 24 Jul 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.
In this project, we aim at implementing a te-ASL sequence and to compare it to two reference ASL sequences with a fixed PLD on healthy individuals. On the one hand, the te-ASL sequence will be compared against a 3D pCASL with a PLD of 1800 ms, as the current reference according the Consensus of the ISMRM perfusion study group and the European consortium for ASL in dementia. On the other, as the implemented te-ASL sequence will have a 2D readout, it will also be compared to a 2D pCASL ASL sequence with the same PLD, in order to be able to disentangle differences due to the dynamic PLD scheme from those arising from the different read-out schemes.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Thirty (N=30) healthy individuals older than 18 years old
Key inclusion criteria (2 listed)
- To sign the study informed consent form approved by the corresponding authorities.
- Healthy men and women (older than 18 years old).
Key exclusion criteria (2 listed)
- Inability or unwillingness to give written informed consent or communicate with the study staff or illiteracy.
- Any contraindication to perform brain MRI procedure (e.g. pacemaker, MRI-incompatible aneurysm clips).
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
ASL perfusion MRI data
Time frame: Through study completion, an average of 1 year
Quantification of cerebral blood flow
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 31 Mar 2023.
- 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 Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 1 site in Spain.
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 2 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 31 Mar 2023. 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 Spain. 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?
ASL perfusion MRI data (time frame: Through study completion, an average of 1 year). 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 31 Mar 2023.