ALTREVE: Description of Lymphatic Damage in Encephalic Venous Thrombosis and Strictures in MRI a Reverse-recovery Sequence: a Pilot Study

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05041569
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 23.5
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

Inclusion (J0):

• Information

• Verification of inclusion and non-inclusion criteria

• Collection of consent

• MRI examination with injection of contrast product as part of the treatment comprising the sequences:

T1 TFE 1.0 iso 3D FLAIR injected Injected elliptical venous angiography 0.4mm iso or less 3D SWIp multiecho 3D T1 injected FABIR iso without injection (added as part of care in case of suspected ASH or meningitis) FLAIR 1.0 without injection (added as part of care for suspected ASH or meningitis) T2 BFFE XD (added by search) FABIR iso injected (added by research) 3D PD T1 0.55 MSDE iso injected (added by research)

Clinical information (SRM on inclusion, on discharge and at 3 months and recurrence within the year) will be collected from the patient's medical file

Condition or Disease	Intervention/Treatment	Phase
Description of Local Modifications of Lymph Nodes or Bundles With the FABIR Sequence in MRI	Other: MRI sequences

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Description of Lymphatic Damage in Encephalic Venous Thrombosis and Strictures in MRI a Reverse-recovery Sequence: a Pilot Study
• Actual Study Start Date: Dec 17, 2021
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Outcome Measures

Primary Outcome Measures

1. Using a new MRI sequence for the detection of lymph nods [1 DAY]

   Inversion recovery pulse sequences in MRI will be used to detect lymph nods.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients over 18 years of age

• Performing an MRI injected as part of care for one of the following reasons:

• suspicion of pathology likely to be associated with narrowing or obstruction of one or more venous sinuses (cerebral thrombophlebitis, tissue damage with venous extension, idiopathic HIC

• venous narrowing or obstruction proven by one of the above pathologies, requiring as part of routine care an injected MRI (search for impact, monitoring, pre-therapeutic assessment or prognosis)

• Express consent to participate in the study

• Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

• Absolute contraindication to MRI

• Patient benefiting from a legal protection measure

• Pregnant or breastfeeding woman

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hhopital fondation adolphe de rothschild	Paris		France	75019

Sponsors and Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
• ClinicalTrials.gov Identifier: NCT05041569
• Other Study ID Numbers: JSY_2021_12
• First Posted: Sep 13, 2021
• Last Update Posted: Mar 21, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Thrombosis; Venous Thrombosis

Study Results

No Results Posted as of Mar 21, 2022