HealthyNCT02402751
Development, Implementation and Initiation of Normative Database Quantitative Ultra High Field MRI Paramaters
A study testing acquisition of normative database with ultra high field MRI and MRI in people with Healthy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The Centre for Magnetic Resonance in Biology and Medicine (CRMBM, UMR-CNRS 7339 AMU) obtained funding for a whole body NMR imaging at 7. It is the only MRI at 7T installed in a hospital in France (only two 7T MRI in France) and therefore a unique opportunity to develop new diagnostic approaches. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- acquisition of normative database with ultra high field MRI and MRI
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to Sep 2019
- Phase
- Interventional
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People not presenting contraindications to the MRI (pacemaker, agitation, metallic brightness, claustrophobia etc.)
- People having no intra-physical object potentially conductive.
- People having no affection after detailed interrogation
Who cannot join
- People staying in a sanitary or social establishment
- People in emergency situation
- People not wishing to be informed about anomalies in the MRI
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Maxime GUYE, M.D contact
Alexandra GIULIANI contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique - Hopitaux de Marseille
Marseille, 13005
Maxime GUYE, MD, maxime.guye@ap-hm.fr
About this study
The Centre for Magnetic Resonance in Biology and Medicine (CRMBM, UMR-CNRS 7339 AMU) obtained funding for a whole body NMR imaging at 7. It is the only MRI at 7T installed in a hospital in France (only two 7T MRI in France) and therefore a unique opportunity to develop new diagnostic approaches.
The purpose of this study is to develop, implement and validate new MRI quantitative parameters derived from ultra high field MRI in order to characterize non-invasively with an unprecedented resolution and sensitivity, anatomy as well as certain physiological, hemodynamic and metabolic function of brain, spinal cord, musculoskeletal system, and heart in healthy subjects
Read the detailed description
The key is that the goal of our projects is not only producing images of better quality than using a 3T scanner but also making images differently, by highlighting new contrasts and features of theses organs in order to improve the diagnosis and prognosis of neurological, psychiatric, cardiovascular and rheumatologic diseases.
- Conditions
- Healthy
- Being tested
- acquisition of normative database with ultra high field MRI, MRI
- Keywords
- Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acquisition of normative database with ultra high field MRIProcedure or surgery
characterize non-invasively with an unprecedented resolution and sensitivity (high field MRI), anatomy as well as certain physiological, hemodynamic and metabolic function of brain, spinal cord, musculoskeletal system, and heart
MRIDevice
| Study group | Role | What they receive |
|---|---|---|
| Acquisition of normative database | Experimental | Development, implementation and initiation of normative database (image and data) quantitative ultra high field MRI paramaters Receives: Procedure: acquisition of normative database with ultra high field MRI; Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
qualitative validation concerning structure visible with high field MRI
the validation criteria are qualitative (contrast and visibility of anatomical structures usually visible 7T but not visible at 3T will be used to assess the sensitivity of images for each modality) and quantitative (signal to noise ratio (SNR), spatial and temporal resolution).
Measured: 4 years
Secondary outcomes (1)
acquisition of normative data and verification of the quality criteria obtained during the first phase
During the second phase, we will acquire normative data and verify the quality criteria of the first phase. Each quantitative variable will be extracted. After the acquisition of the first 30 volunteers for each parameter, the variance will be analyzed to assess the population distribution. Depending on the results, and issues raised by clinical research studies, other populations will be acquired
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2019 (estimated)
- Study completionSep 2019 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime GUYE, M.D, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402751
- Sponsor's protocol ID
- 2015-A0012148
- Status last verified
- Aug 2016
- First submitted
- 25 Mar 2015
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Implementation and Initiation of Normative Database Quantitative Ultra High Field MRI Paramaters
- ClinicalTrials.gov ID
- NCT02402751
- Acronym / sponsor ID
- 2015-A0012148
- Conditions
- Healthy
- Keywords
- Volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 30 Mar 2015 (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.
The Centre for Magnetic Resonance in Biology and Medicine (CRMBM, UMR-CNRS 7339 AMU) obtained funding for a whole body NMR imaging at 7. It is the only MRI at 7T installed in a hospital in France (only two 7T MRI in France) and therefore a unique opportunity to develop new diagnostic approaches.
The purpose of this study is to develop, implement and validate new MRI quantitative parameters derived from ultra high field MRI in order to characterize non-invasively with an unprecedented resolution and sensitivity, anatomy as well as certain physiological, hemodynamic and metabolic function of brain, spinal cord, musculoskeletal system, and heart in healthy subjects
Detailed description
The key is that the goal of our projects is not only producing images of better quality than using a 3T scanner but also making images differently, by highlighting new contrasts and features of theses organs in order to improve the diagnosis and prognosis of neurological, psychiatric, cardiovascular and rheumatologic diseases.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acquisition of normative database | Experimental | Procedure: acquisition of normative database with ultra high field MRI, Device: MRIDevelopment, implementation and initiation of normative database (image and data) quantitative ultra high field MRI paramaters |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- People not presenting contraindications to the MRI (pacemaker, agitation, metallic brightness, claustrophobia etc.)
- People having no intra-physical object potentially conductive.
- People having no affection after detailed interrogation
Key exclusion criteria (4 listed)
- People staying in a sanitary or social establishment
- People in emergency situation
- People not wishing to be informed about anomalies in the MRI
- Pregnancy
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 |
|---|---|---|
| acquisition of normative database with ultra high field MRIcharacterize non-invasively with an unprecedented resolution and sensitivity (high field MRI), anatomy as well as certain physiological, hemodynamic and metabolic function of brain, spinal cord, musculoskeletal system, and heart | Procedure or surgery | Acquisition of normative database |
| MRI | Device | Acquisition of normative database |
Primary outcome
qualitative validation concerning structure visible with high field MRI
Time frame: 4 years
the validation criteria are qualitative (contrast and visibility of anatomical structures usually visible 7T but not visible at 3T will be used to assess the sensitivity of images for each modality) and quantitative (signal to noise ratio (SNR), spatial and temporal resolution).
1 secondary outcome
acquisition of normative data and verification of the quality criteria obtained during the first phase
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
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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.
Maxime GUYE, M.D contact
Alexandra GIULIANI contact
Maxime GUYE, M.D principal investigator
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acquisition of normative database with ultra high field MRI and MRI in people with Healthy, run by Assistance Publique Hopitaux De Marseille 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 3 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 24 Aug 2016. 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 Maxime GUYE, M.D (mgue@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
qualitative validation concerning structure visible with high field MRI (time frame: 4 years). 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 24 Aug 2016.