HealthyOSS-IRMNCT03440983
OSS-IRM: Optimization of MRI Sequences in Healthy Volunteers
A study testing MRI data acquiring in healthy volunteers in people with Healthy, run by Rennes University Hospital at 1 site in France.
Trial summary
Using MRI, many technical parameters can be changed to optimize the diagnostic quality of the examination. The study is interventionnal because healthy volunteers are not supposed to have an MRI exam. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MRI data acquiring in healthy volunteers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Dec 2022
- 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
- Male or female subject,
- Aged 18 or above
Who cannot join
- Patient with any surgical clip, external clips, or any other ferromagnetic device, that is contraindicated for use in MRI
- Claustrophobic patient
- Pregnancy
- Breastfeeding
- Patients subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
- No healthcare insurance
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Radiology Department CHU de Rennes
Rennes, 35033
drc drc, 2 99 28 25 55, drc@chu-rennes.fr
Jean-Christophe Ferre
About this study
Using MRI, many technical parameters can be changed to optimize the diagnostic quality of the examination. The study is interventionnal because healthy volunteers are not supposed to have an MRI exam.
The primary objective of this study is to optimize the imaging protocols and to validate the choice of the technical parameters in healthy volunteers.
The quality of the images, cartographies or spectres will be compared to standard acquisitions. This evaluation will be based on qualitative visual criteria assessed by expert radiologists or on quantitative criteria assessed by data processing tools.
Read the detailed description
Using MRI, many technical parameters (sequence, parameters in the sequence, reconstruction method, etc.) can be changed to optimize the diagnostic quality of the examination.
The primary objective of this study is to optimize the imaging protocols and to validate the choice of the technical parameters in healthy volunteers.
The quality of the images, cartographies or spectres will be compared to standard acquisitions. This evaluation will be based on qualitative visual criteria assessed by expert radiologists or on quantitative criteria assessed by data processing tools.
Prospective, single-center, observational MRI study A screening visit is planned to check the inclusion/non inclusion criteria followed by an imaging visit during which the MRI examination will be performed.
Theses 2 visits are scheduled at the subject's convenience. The number of participations to the study is limited to 5 per year per subject.
- Conditions
- Healthy
- Being tested
- MRI data acquiring in healthy volunteers
- Keywords
- optimize the imaging protocols, validate technical parameters in healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI data acquiring in healthy volunteersDevice
The quality of the images, cartographies or spectres will be compared to standard acquisitions. This evaluation will be based on qualitative visual criteria assessed by expert radiologists or on quantitative criteria assessed by data processing tools
| Study group | Role | What they receive |
|---|---|---|
| MRI data acquiring in healthy volunteers | Experimental | MRI data acquiring in healthy volonteers Receives: Device: MRI data acquiring in healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI data acquisition : quality of the images, cartographies or spectres
The quality of the images, cartographies or spectres will be compared to standard acquisitions. This evaluation will be based on qualitative visual criteria assessed by expert radiologists or on quantitative criteria assessed by data processing tools
Measured: 0.5 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study startApr 2013
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (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.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440983
- Sponsor's protocol ID
- 2011-A01531-40
- Acronym
- OSS-IRM
- Status last verified
- Feb 2018
- First submitted
- 8 Apr 2013
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OSS-IRM: Optimization of MRI Sequences in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03440983
- Acronym / sponsor ID
- OSS-IRM / 2011-A01531-40
- Conditions
- Healthy
- Keywords
- optimize the imaging protocols, validate technical parameters in healthy volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 22 Feb 2018 (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.
Using MRI, many technical parameters can be changed to optimize the diagnostic quality of the examination. The study is interventionnal because healthy volunteers are not supposed to have an MRI exam.
The primary objective of this study is to optimize the imaging protocols and to validate the choice of the technical parameters in healthy volunteers.
The quality of the images, cartographies or spectres will be compared to standard acquisitions. This evaluation will be based on qualitative visual criteria assessed by expert radiologists or on quantitative criteria assessed by data processing tools.
Detailed description
Using MRI, many technical parameters (sequence, parameters in the sequence, reconstruction method, etc.) can be changed to optimize the diagnostic quality of the examination.
The primary objective of this study is to optimize the imaging protocols and to validate the choice of the technical parameters in healthy volunteers.
The quality of the images, cartographies or spectres will be compared to standard acquisitions. This evaluation will be based on qualitative visual criteria assessed by expert radiologists or on quantitative criteria assessed by data processing tools.
Prospective, single-center, observational MRI study A screening visit is planned to check the inclusion/non inclusion criteria followed by an imaging visit during which the MRI examination will be performed.
Theses 2 visits are scheduled at the subject's convenience. The number of participations to the study is limited to 5 per year per subject.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI data acquiring in healthy volunteers | Experimental | Device: MRI data acquiring in healthy volunteersMRI data acquiring in healthy volonteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female subject,
- Aged 18 or above
Key exclusion criteria (6 listed)
- Patient with any surgical clip, external clips, or any other ferromagnetic device, that is contraindicated for use in MRI
- Claustrophobic patient
- Pregnancy
- Breastfeeding
- Patients subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
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 |
|---|---|---|
| MRI data acquiring in healthy volunteersThe quality of the images, cartographies or spectres will be compared to standard acquisitions. This evaluation will be based on qualitative visual criteria assessed by expert radiologists or on quantitative criteria assessed by data processing tools | Device | MRI data acquiring in healthy volunteers |
Primary outcome
MRI data acquisition : quality of the images, cartographies or spectres
Time frame: 0.5 day
The quality of the images, cartographies or spectres will be compared to standard acquisitions. This evaluation will be based on qualitative visual criteria assessed by expert radiologists or on quantitative criteria assessed by data processing tools
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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?
A study testing MRI data acquiring in healthy volunteers in people with Healthy, 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 6 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 28 Sep 2018. 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 drc drc (00 (33) 2 99 28 25 55 ext. 0033, drc@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI data acquisition : quality of the images, cartographies or spectres (time frame: 0.5 day). 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 28 Sep 2018.