Dysthyroid OphthalmopathiesDDXNCT02397109
mDixon TSE MRI Sequence And Conventional MRI Sequences In Dysimmune Orbitopathies (DDX)
An observational study of Dysthyroid Ophthalmopathies, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
The dysthyroid orbitopathy (DO) is a chronic disease, evolving during 2 to 3 years, with a hypertrophy and a variable degree of inflammation of the eyelid muscles, the oculomotor muscles and the orbital fat. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Dysthyroid Ophthalmopathies
- How many people
- 294 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2015to Sep 2020
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a dysthyroid orbitopathy undergoing a MRI
Who may be able to join
- Patient aged 18 to 90 years, suffering from thyroid dysfunction proved by clinical and laboratory tests, with a bilateral clinical dysthyroid orbitopathy and undergoing an eye MRI
Who cannot join
- Absolute or relative contra-indication to MRI or to a contrast agent gadolinium injection (including pregnant or likely to be, breastfeeding women)
- Patient under guardianship
- Patient not willing to participate.
- Lack of affiliation to social security or medical state aid (AME) or universal health coverage (CMU)
- Motion artifact on the sequences, not corrected by the repeat sequences
- Metal artifact prohibiting the analysis of the region of interest
Trial locations and contacts
1 site in 1 country.
France1 site
Fondation Ophtalmologique Adolphe de Rothschild
Paris, Île-de-France Region, 75019
About this study
Official title: Study Of The Agreement Between The mDixon TSE Sequence And Conventional MRI Sequences In The Evaluation Of Dysimmune Orbitopathies
The dysthyroid orbitopathy (DO) is a chronic disease, evolving during 2 to 3 years, with a hypertrophy and a variable degree of inflammation of the eyelid muscles, the oculomotor muscles and the orbital fat.
If the diagnosis of OD is primarily clinical and laboratory, MRI is an additional contribution to the clinic, guiding the therapeutic management by detecting inflammatory lesions not found on clinical examination in 1/3 of cases.
Read more
The three MRI sequences conventionally practiced ((T2, T2-fat-sat, T1) allow muscles signal analysis oculomotor abnormalities as well as the orbital fat.
Compared to these sequences, the main advantage sequences DIXON is a faster acquisition. In addition, DIXON type of imaging overcomes most of these artifacts and to obtain a homogeneous fat removal.
- Conditions
- Dysthyroid Ophthalmopathies
- Medical subject headings
- Graves Ophthalmopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment, by the determination of the Cohen's kappa coefficient, of the concordance between the conventional sequences (T1, T2, T2-fat-sat) and the mDIXON sequence for the diagnosis of inflammatory or non-inflammatory dysthyroid orbitopathy.
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study start4 Apr 2015
- Primary completionSep 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysthyroid OphthalmopathiesStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397109
- Sponsor's protocol ID
- ALR_2015-1
- Acronym
- DDX
- Status last verified
- May 2021
- First submitted
- 19 Mar 2015
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Of The Agreement Between The mDixon TSE Sequence And Conventional MRI Sequences In The Evaluation Of Dysimmune Orbitopathies
- ClinicalTrials.gov ID
- NCT02397109
- Acronym / sponsor ID
- DDX / ALR_2015-1
- Conditions
- Dysthyroid Ophthalmopathies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 4 Apr 2015 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 24 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 dysthyroid orbitopathy (DO) is a chronic disease, evolving during 2 to 3 years, with a hypertrophy and a variable degree of inflammation of the eyelid muscles, the oculomotor muscles and the orbital fat.
If the diagnosis of OD is primarily clinical and laboratory, MRI is an additional contribution to the clinic, guiding the therapeutic management by detecting inflammatory lesions not found on clinical examination in 1/3 of cases.
The three MRI sequences conventionally practiced ((T2, T2-fat-sat, T1) allow muscles signal analysis oculomotor abnormalities as well as the orbital fat.
Compared to these sequences, the main advantage sequences DIXON is a faster acquisition. In addition, DIXON type of imaging overcomes most of these artifacts and to obtain a homogeneous fat removal.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a dysthyroid orbitopathy undergoing a MRI
Key inclusion criteria (1 listed)
- Patient aged 18 to 90 years, suffering from thyroid dysfunction proved by clinical and laboratory tests, with a bilateral clinical dysthyroid orbitopathy and undergoing an eye MRI
Key exclusion criteria (6 listed)
- Absolute or relative contra-indication to MRI or to a contrast agent gadolinium injection (including pregnant or likely to be, breastfeeding women)
- Patient under guardianship
- Patient not willing to participate.
- Lack of affiliation to social security or medical state aid (AME) or universal health coverage (CMU)
- Motion artifact on the sequences, not corrected by the repeat sequences
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
Assessment, by the determination of the Cohen's kappa coefficient, of the concordance between the conventional sequences (T1, T2, T2-fat-sat) and the mDIXON sequence for the diagnosis of inflammatory or non-inflammatory dysthyroid orbitopathy.
Time frame: One hour
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 27 May 2021.
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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 Dysthyroid Ophthalmopathies, run by Fondation Ophtalmologique Adolphe de Rothschild 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 1 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: finished, as of the sponsor's last update on 27 May 2021. 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?
Assessment, by the determination of the Cohen's kappa coefficient, of the concordance between the conventional sequences (T1, T2, T2-fat-sat) and the mDIXON sequence for the diagnosis of inflammatory or non-inflammatory dysthyroid orbitopathy. (time frame: One hour). 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 27 May 2021.