Ophthalmoplegia3D-IIINCT03269682
Prevalence of Contrast Enhancement of the Oculomotor Nerve on 3D PD T1 MRI Sequence in Patients With Ophthalmoplegia
An observational study of Ophthalmoplegia, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Oculomotor nerve (third cranial nerve or "III") palsy is a relatively frequent cause of consultation in ophthalmology. It may reveal a life-threatening pathology such as aneurysm rupture, pituitary apoplexy, and therefore need imaging in emergency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ophthalmoplegia
- What is being tested?
- 3D PD T1 MRI sequence
- Type of treatment
- Medical device
- How many people
- 134 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2017to 16 Apr 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with ophtalmoplegia
Who may be able to join
- Ophthalmoplegia whatever the clinical form (unilateral or not, isolated or not, sudden or progressive onset)
Who cannot join
- -Absolute contraindication to MRI or injection of contrast agents.
Trial locations and contacts
1 site in 1 country.
About this study
Oculomotor nerve (third cranial nerve or "III") palsy is a relatively frequent cause of consultation in ophthalmology.
It may reveal a life-threatening pathology such as aneurysm rupture, pituitary apoplexy, and therefore need imaging in emergency. Apart from few extreme emergency situations, MRI of the oculomotor tract is the first-line examination required. In our usual clinical practice, we noticed in several patients unusual contrast enhancement within the oculomotor nerve on T1 sequence with gadolinium injection, observed in various locations along the nerve path (cavernous and/ or intra-orbital segment).
Read more
This contrast enhancement, could confirm the nerve impairment This study aims to analyse the efficiency of a new sequence 3D PD T1 which isotropic spatial resolution less than 1mm, not yet described in the literature, to depict this enhancement.
In patients with ophthalmoplegia involving probably the third cranial nerve, disclosing this MRI sign could help (i) to confirm the involvement of the oculomotor nerve and eliminate differential diagnoses such as myasthenia (ii) to orientate the etiological diagnosis (inflammatory or ischemic origin). This new sequence 3D PD T1 sequence focused on the III could thus be systematically included in the usual MRI protocol.
- Conditions
- Ophthalmoplegia
- Being tested
- 3D PD T1 MRI sequence
- Medical subject headings
- Ophthalmoplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D PD T1 MRI sequenceDevice
After MRI has been performed (about 5 minutes of additional time compared to the usual sequences), a double reading of the MRI will be performed by two radiologists (1 experienced and 1 junior).
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast enhancement of the oculomotor nerve on 3D PD T1 MRI sequence (presence or absence, determined by a radiologist)
A double separate reading of the imaging will be carried out by an experienced radiologist and a junior radiologist on anonymized MRIs, with no access to clinical elements and interpretation of the other radiologist. In case of discrepancy between the radiologists, the final decision will be made by a third experienced radiologist under the same conditions (no access to clinical data, no access to the other evaluations).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start20 Oct 2017
- Primary completion16 Apr 2021
- Study completion16 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OphthalmoplegiaStudies 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
- 134 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
- NCT03269682
- Sponsor's protocol ID
- FHN_2017_4
- Acronym
- 3D-III
- Status last verified
- Sep 2021
- First submitted
- 30 Aug 2017
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Contrast Enhancement of the Oculomotor Nerve on 3D PD T1 MRI Sequence in Patients With Ophthalmoplegia
- ClinicalTrials.gov ID
- NCT03269682
- Acronym / sponsor ID
- 3D-III / FHN_2017_4
- Conditions
- Ophthalmoplegia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 1 Sep 2017 (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.
Oculomotor nerve (third cranial nerve or "III") palsy is a relatively frequent cause of consultation in ophthalmology.
It may reveal a life-threatening pathology such as aneurysm rupture, pituitary apoplexy, and therefore need imaging in emergency. Apart from few extreme emergency situations, MRI of the oculomotor tract is the first-line examination required. In our usual clinical practice, we noticed in several patients unusual contrast enhancement within the oculomotor nerve on T1 sequence with gadolinium injection, observed in various locations along the nerve path (cavernous and/ or intra-orbital segment).
This contrast enhancement, could confirm the nerve impairment This study aims to analyse the efficiency of a new sequence 3D PD T1 which isotropic spatial resolution less than 1mm, not yet described in the literature, to depict this enhancement.
In patients with ophthalmoplegia involving probably the third cranial nerve, disclosing this MRI sign could help (i) to confirm the involvement of the oculomotor nerve and eliminate differential diagnoses such as myasthenia (ii) to orientate the etiological diagnosis (inflammatory or ischemic origin). This new sequence 3D PD T1 sequence focused on the III could thus be systematically included in the usual MRI protocol.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with ophtalmoplegia
Key inclusion criteria (1 listed)
- Ophthalmoplegia whatever the clinical form (unilateral or not, isolated or not, sudden or progressive onset)
Key exclusion criteria (1 listed)
- -Absolute contraindication to MRI or injection of contrast agents.
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 |
|---|---|---|
| 3D PD T1 MRI sequenceAfter MRI has been performed (about 5 minutes of additional time compared to the usual sequences), a double reading of the MRI will be performed by two radiologists (1 experienced and 1 junior). | Device | – |
Primary outcome
Contrast enhancement of the oculomotor nerve on 3D PD T1 MRI sequence (presence or absence, determined by a radiologist)
Time frame: Baseline
A double separate reading of the imaging will be carried out by an experienced radiologist and a junior radiologist on anonymized MRIs, with no access to clinical elements and interpretation of the other radiologist. In case of discrepancy between the radiologists, the final decision will be made by a third experienced radiologist under the same conditions (no access to clinical data, no access to the other evaluations).
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 17 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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 Ophthalmoplegia, 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 1 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 17 Sep 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?
Contrast enhancement of the oculomotor nerve on 3D PD T1 MRI sequence (presence or absence, determined by a radiologist) (time frame: Baseline). 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 17 Sep 2021.