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Trial record 5 of 26 for:    papilledema

Precise High Resolution MRI to Increase Accuracy and Gain Confidence to Diagnose Patients With Optic Disc Edema (PAGODE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04448613
Recruitment Status : Recruiting
First Posted : June 26, 2020
Last Update Posted : September 17, 2021
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:

The presence of optic disc swelling at the fundus is a non-specific clinical sign that can occur in many ophthalmologic, neuro-ophthalmologic or encephalic pathologies. The diagnostic range is vast, including inflammatory pathologies of the optic nerve, infiltrative or compressive orbital pathologies, idiopathic or secondary intracranial hypertensions, not to mention the pseudo optic disc swelling found in drüsens.

MRI is increasingly being used as a first-line examination to obtain an etiologic diagnosis in a patient with optic disc swelling. It allows a rapid diagnosis to be made in cases of inflammatory pathology or compressive or infiltrative pathology. It can provide very suggestive elements in the case of intracranial hypertension. It appears to be potentially useful in diagnosing ischemic optic neuropathy or in directing towards an etiological diagnosis of Giant Cell Arteritis.

The development of new high-resolution MRI sequences has made it possible to obtain extremely fine resolutions of a few hundred microns in the plane. Apart from a few clinical cases and small series, there is no precise evaluation of the interest of these new sequences in the positive and etiological diagnosis of ophthalmological, neuro-ophthalmological and encephalic pathologies responsible for the presence of optic disc swelling.

The objective of our study is therefore to evaluate the diagnostic contribution and the gain in diagnostic confidence provided by these new sequences in the context of pathologies manifesting as optic disc swelling.


Condition or disease Intervention/treatment
Optic Disk Magnetic Resonance Imaging Other: MRI

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Precise High Resolution MRI to Increase Accuracy and Gain Confidence to Diagnose Patients With Optic Disc Edema
Actual Study Start Date : June 17, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema


Intervention Details:
  • Other: MRI

    Patients with optic disc swelling diagnosed by a fundus and included in the study will have a brain MRI and visual pathways lasting 30 minutes.

    Two additional 10-minute sequences will be added to the standard protocol.



Primary Outcome Measures :
  1. FLAIR hypersignal size: larger diameters and area [ Time Frame: baseline ]
    larger diameters and area of FLAIR hypersignal



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to the radiology service of the A. de Rothschild foundation and presenting a papillary edema detected clinically at the back of the eye sent by the emergency department for an MRI
Criteria

Inclusion Criteria:

  • Patient over 18 years old
  • presenting a papillary edema detected clinically at the back of the eye
  • Express consent to participate in the study
  • Affiliate or beneficiary of a Social Security scheme

Exclusion Criteria:

  • MRI contraindication (electrical device, metallic foreign body, claustrophobia)
  • Patient benefiting from a legal protection measure
  • Pregnant or breastfeeding woman

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04448613


Contacts
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Contact: amé YAVCHITZ 0148036431 ayavchitz@for.paris

Locations
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France
Fondation Ophtalmologique Adolphe de Rothschild (FOR) Recruiting
Paris, France, 75019
Contact: Amélie YAVCHITZ    0148036431    ayavchitz@for.paris   
Principal Investigator: Augustin LECLER         
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT04448613    
Other Study ID Numbers: 2020-A00502-37
First Posted: June 26, 2020    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Papilledema
Optic Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases