Healthy VolunteersOSS-IRMNCT02900339
Magnetic Resonance Imaging (MRI) Sequences Optimization in Healthy Subjects
A study testing Magnetic Resonance Imaging in people with Healthy Volunteers, run by Rennes University Hospital at 1 site in France.
Trial summary
Magnetic resonance imaging (MRI) is a noninvasive and non-ionizing (no use of X-rays) imaging modality. Today it is considered an anatomical and functional exploration reference technique. Since its inception around 1985, this technology is constantly evolving. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Magnetic Resonance Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 628 participants
- Where
- 1 siteFrance
- Study dates
- 18 Apr 2013to 12 Oct 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women aged over 18 years
- Written informed consent given
Who cannot join
- contraindication to MRI :
- Claustrophobia
- morphotype not allowing access to MRI
- Wear a metallic implant, such as:
- Pacemaker (pacemaker)
- Ferromagnetic surgical clips
Show all 11Show fewer
- Intra orbital metallic foreign bodies or encephalic
- Pregnancy
- Breastfeeding
- Adults under guardianship, trusteeship or safeguard justice
- No social Insurance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MRI Sequences Optimization in Healthy Subjects
Magnetic resonance imaging (MRI) is a noninvasive and non-ionizing (no use of X-rays) imaging modality. Today it is considered an anatomical and functional exploration reference technique. Since its inception around 1985, this technology is constantly evolving.
Many advances in MRI require constant adaptations of radiological practices. The morphological image is now associated with functional and parametric information (infusion, diffusion spectroscopy, etc ...). In parallel, work combining acquisition and post-processing of data also open new applications (tractography, functional MRI, etc ....). Thus, more and more procedures are necessary to "integrate" these techniques for the diagnosis and adapt to new demands of clinicians.
Read more
The type of sequence and its associated parameters allow to directly influence the contrast of images, to characterize tissue compared to another and, ultimately, to highlight morphological or functional abnormality. Image quality can be optimized on each MRI, depending on the time available for the acquisition on the one hand, and on the desired resolution and contrast, on the other hand. For each sequence, it is therefore necessary to find a compromise that will optimize the diagnostic quality of the examination.
This optimization requires a phase focusing on healthy volunteers. It is therefore important that researchers and physicists could design on healthy volunteers, the best settings of all parameters for an image or spectrum. Indeed, it is always necessary to properly optimize every parameter choices before beginning a study of a cohort of patients.
In this context, the main objective of this study is to optimize sequences and imaging protocols to evaluate and validate the choice of parameters in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- Magnetic Resonance Imaging
- Keywords
- MRI, Sequence optimization, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDevice
Also called Magnetom
MRI of the Neurinfo platform is an MRI 3 Tesla Magnetom Verio model, Siemens (Siemens Healthcare, Erlangen, Germany). This imager is marked for European Conformity (CE), ensuring compliance with European Union safety standards.
| Study group | Role | What they receive |
|---|---|---|
| MR parameters optimization | Experimental | The study will be conducted on the MRI of the Neurinfo platform, in the radiology department of the University Hospital of Rennes. Receives: Device: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative assessment of acquired sequences
Quality images, maps or spectra acquired with optimized parameters will be compared to standard acquisitions.
This evaluation will be based on quantitative criteria extracted from computer analysis of the data : signal to noise ratio, contrast-to-noise, blur level, information sharing, collocation of areas set evidenced by the different techniques, etc...
Measured: One day after data acquisitions
Secondary outcomes (1)
Qualitative assessment of acquired sequences
Quality images, maps or spectra acquired with optimized parameters will be compared to standard acquisitions.
This evaluation will be based on statistical comparison of visual qualitative criteria by experts radiologists
Measured: One day after data acquisitions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study start18 Apr 2013
- Primary completion12 Oct 2021
- Study completion12 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Rennes 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 628 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe FERRE, MD, PhD, Study director, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900339
- Sponsor's protocol ID
- 35RC11_8965
- Other IDs
- 2011-A01531-40
- Acronym
- OSS-IRM
- Status last verified
- Dec 2022
- First submitted
- 9 Sep 2016
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Sequences Optimization in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02900339
- Acronym / sponsor ID
- OSS-IRM / 35RC11_8965
- Conditions
- Healthy Volunteers
- Keywords
- MRI, Sequence optimization, Healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 628 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 18 Apr 2013 (actual)
- Primary completion
- 12 Oct 2021 (actual)
- Study completion
- 12 Oct 2021 (actual)
- First posted
- 14 Sep 2016 (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.
Magnetic resonance imaging (MRI) is a noninvasive and non-ionizing (no use of X-rays) imaging modality. Today it is considered an anatomical and functional exploration reference technique. Since its inception around 1985, this technology is constantly evolving.
Many advances in MRI require constant adaptations of radiological practices. The morphological image is now associated with functional and parametric information (infusion, diffusion spectroscopy, etc ...). In parallel, work combining acquisition and post-processing of data also open new applications (tractography, functional MRI, etc ....). Thus, more and more procedures are necessary to "integrate" these techniques for the diagnosis and adapt to new demands of clinicians.
The type of sequence and its associated parameters allow to directly influence the contrast of images, to characterize tissue compared to another and, ultimately, to highlight morphological or functional abnormality. Image quality can be optimized on each MRI, depending on the time available for the acquisition on the one hand, and on the desired resolution and contrast, on the other hand. For each sequence, it is therefore necessary to find a compromise that will optimize the diagnostic quality of the examination.
This optimization requires a phase focusing on healthy volunteers. It is therefore important that researchers and physicists could design on healthy volunteers, the best settings of all parameters for an image or spectrum. Indeed, it is always necessary to properly optimize every parameter choices before beginning a study of a cohort of patients.
In this context, the main objective of this study is to optimize sequences and imaging protocols to evaluate and validate the choice of parameters in healthy volunteers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR parameters optimization | Experimental | Device: Magnetic Resonance ImagingThe study will be conducted on the MRI of the Neurinfo platform, in the radiology department of the University Hospital of Rennes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men or women aged over 18 years
- Written informed consent given
Key exclusion criteria (11 listed)
- contraindication to MRI :
- Pregnancy
- Breastfeeding
- Adults under guardianship, trusteeship or safeguard justice
- No social Insurance
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 |
|---|---|---|
| Magnetic Resonance ImagingAlso: MagnetomMRI of the Neurinfo platform is an MRI 3 Tesla Magnetom Verio model, Siemens (Siemens Healthcare, Erlangen, Germany). This imager is marked for European Conformity (CE), ensuring compliance with European Union safety standards. | Device | MR parameters optimization |
Primary outcome
Quantitative assessment of acquired sequences
Time frame: One day after data acquisitions
Quality images, maps or spectra acquired with optimized parameters will be compared to standard acquisitions. This evaluation will be based on quantitative criteria extracted from computer analysis of the data : signal to noise ratio, contrast-to-noise, blur level, information sharing, collocation of areas set evidenced by the different techniques, etc...
1 secondary outcome
Qualitative assessment of acquired sequences
Time frame: One day after data acquisitions
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 14 Dec 2022.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Jean-Christophe FERRE, MD, PhD study director
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging in people with Healthy Volunteers, run by Rennes University Hospital 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 2 inclusion and 11 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 14 Dec 2022. 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?
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?
Quantitative assessment of acquired sequences (time frame: One day after data acquisitions). 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 Dec 2022.