NeurosciencesOPT-IRMNCT05618990
OPTIMIZATION of ADVANCED MR SEQUENCES
An observational study of Neurosciences and MRI, run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
This monocentric methodological study aims at optimizing advanced MR sequences for image quality (reduced artefacts, signal to noise ratio, acquisition time, stability of quantitative measurements) on a new MR unit dedicated to research in clinical and cognitive neuroscience. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurosciences, MRI, Brain Tumor
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2019to 5 Dec 2025
- 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 volunteers or patients with brain lesions
Who may be able to join
- 18 ans
- Covered by social security
- For women in age of procreation, under efficient contraception
- Written consent
Who cannot join
- Any MR contraindication
- Claustrophobia
- Pregnancy
- Under judiciary protection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
OPPENHEIM Catherine
Paris, 75014
OPPENHEIM Catherine, C.OPPENHEIM@ghu-paris.fr
OPPENHEIM Catherine, Doctor
About this study
Official title: OPTIMIZATION of AVANCED MR SEQUENCES for BRAIN STUDIES in VOLUNTEERS (HEALTHY and PATIENTS)
This monocentric methodological study aims at optimizing advanced MR sequences for image quality (reduced artefacts, signal to noise ratio, acquisition time, stability of quantitative measurements) on a new MR unit dedicated to research in clinical and cognitive neuroscience.
Read the detailed description
Primary goal : Optimization of MR protocols and validation of acquisition parameters of advanced MR sequences on healthy volunteers or patients on a new 3T MR unit dedicated to research in neurosciences.
Secondary goals
- Perform acquisitions to validate the feasibility of research MR protocols (pilot subjects)
- reproducibility studies
- Conditions
- Neurosciences, MRI, Brain Tumor, Mental Disorders, Stroke
- Medical subject headings
- Brain Neoplasms, Mental Disorders, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
MR sequences optimization
Optimization of MR protocols and validation of acquisition parameters of advanced MR sequences on healthy volunteers or patients on a new 3T MR unit dedicated to research in neurosciences. Outcome measures depend on each pulse optimized sequence (signal-to-noise ratio, contrast-to-noise ratio, quantitative MR biomarkers).
Measured: 72 months
Secondary outcomes (2)
Reproducibility studies
Reproducibility studies (quantitative parameters, effect of denoising ...). Outcome measures depend on each pulse optimized sequence (artifacts, signal-to-noise ratio, contrast-to-noise ratio, quantitative MR biomarkers).
Measured: 72 months
Pilot studies
Feasibility studies in cognitive neurosciences. Outcome measures depend on each MR protocol (artifacts, signal-to-noise ratio, contrast-to-noise ratio, quantitative MR biomarkers).
Measured: 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start5 Nov 2019
- Primary completion5 Nov 2025 (estimated)
- Study completion5 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurosciencesStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618990
- Sponsor's protocol ID
- D19-P005
- Acronym
- OPT-IRM
- Status last verified
- Jul 2024
- First submitted
- 8 Nov 2022
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIMIZATION of AVANCED MR SEQUENCES for BRAIN STUDIES in VOLUNTEERS (HEALTHY and PATIENTS)
- ClinicalTrials.gov ID
- NCT05618990
- Acronym / sponsor ID
- OPT-IRM / D19-P005
- Conditions
- Neurosciences, MRI, Brain Tumor, Mental Disorders, Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 5 Nov 2025 (estimated)
- Study completion
- 5 Dec 2025 (estimated)
- First posted
- 16 Nov 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.
This monocentric methodological study aims at optimizing advanced MR sequences for image quality (reduced artefacts, signal to noise ratio, acquisition time, stability of quantitative measurements) on a new MR unit dedicated to research in clinical and cognitive neuroscience.
Detailed description
Primary goal : Optimization of MR protocols and validation of acquisition parameters of advanced MR sequences on healthy volunteers or patients on a new 3T MR unit dedicated to research in neurosciences.
Secondary goals
- Perform acquisitions to validate the feasibility of research MR protocols (pilot subjects)
- reproducibility studies
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers or patients with brain lesions
Key inclusion criteria (4 listed)
- 18 ans
- Covered by social security
- For women in age of procreation, under efficient contraception
- Written consent
Key exclusion criteria (4 listed)
- Any MR contraindication
- Claustrophobia
- Pregnancy
- Under judiciary protection
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
MR sequences optimization
Time frame: 72 months
Optimization of MR protocols and validation of acquisition parameters of advanced MR sequences on healthy volunteers or patients on a new 3T MR unit dedicated to research in neurosciences. Outcome measures depend on each pulse optimized sequence (signal-to-noise ratio, contrast-to-noise ratio, quantitative MR biomarkers).
2 secondary outcomes
Reproducibility studies
Time frame: 72 months
Pilot studies
Time frame: 72 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
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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.
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 Neurosciences and MRI, run by Centre Hospitalier St Anne at 1 site in France.
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 4 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: status not confirmed, as of the sponsor's last update on 10 Jul 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khaoussou SYLLA (01 45 65 76 78 ext. 0033, k.sylla@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MR sequences optimization (time frame: 72 months). 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 10 Jul 2024.