Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 27 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 : April 7, 2022
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Tracking Information
First Submitted Date June 22, 2020
First Posted Date June 26, 2020
Last Update Posted Date April 7, 2022
Actual Study Start Date June 17, 2020
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 25, 2020)
FLAIR hypersignal size: larger diameters and area [ Time Frame: baseline ]
larger diameters and area of FLAIR hypersignal
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Precise High Resolution MRI to Increase Accuracy and Gain Confidence to Diagnose Patients With Optic Disc Edema
Official Title Precise High Resolution MRI to Increase Accuracy and Gain Confidence to Diagnose Patients With Optic Disc Edema
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Optic Disk
  • Magnetic Resonance Imaging
Intervention 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.

Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 25, 2020)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: amé YAVCHITZ 0148036431 ayavchitz@for.paris
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04448613
Other Study ID Numbers 2020-A00502-37
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Fondation Ophtalmologique Adolphe de Rothschild
Original Responsible Party Same as current
Current Study Sponsor Fondation Ophtalmologique Adolphe de Rothschild
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Fondation Ophtalmologique Adolphe de Rothschild
Verification Date April 2022