Imaging lymphatic vessels in patients with idiopathic intracranial hypertension
MR Lymphatic Imaging in Idiopathic Intracranial Hypertension
This study is testing how lymphatic vessels might affect people with idiopathic intracranial hypertension, which causes headaches and vision problems, by using advanced MRI scans.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France Government |
| Locations | 1 site (Paris, Ile de France) |
| Trial ID | NCT05762367 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the role of dural lymphatics in the pathophysiology of idiopathic intracranial hypertension (IIH), a condition characterized by increased intracranial pressure leading to severe headaches and visual loss. Using 3T MRI with Gadobutrol injection, the research will assess the contribution of these lymphatic vessels to the disease process, particularly focusing on the relationship between dural venous stenoses and fluid retention in the central nervous system. The study will include participants aged 18 to 40 years who meet specific diagnostic criteria for IIH, allowing for a detailed exploration of the underlying mechanisms of this neurological disorder.
Who should consider this trial
Good fit: Ideal candidates for this study are females aged 18 to 40 years with a definite diagnosis of idiopathic intracranial hypertension.
Not a fit: Patients with a history of neurosurgical or endovascular neurological procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for patients suffering from idiopathic intracranial hypertension.
How similar studies have performed: While the role of dural lymphatics in neurological disorders is being explored, this specific approach in idiopathic intracranial hypertension is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * For all participants: Age \> 18 years and ≤ 40 years female gender Absence of previous neurosurgical or endovascular neurological history Participant able to express her consent Medical insurance * For participants with IIH No required criterion of severity or evolution of IIH Definite diagnosis of IIH according to Dandy's modified criteria. All of the following criteria must be met and verified by medical reports or certificates from a neurologist, especially the value of the CSF opening pressure measured during the lumbar puncture must be clearly noted on the reports * History of papilledema * Normal neurological examination, except for paralysis of the VIth cranial nerve * Neuroimaging: normal cerebral parenchyma without hydrocephalus, intracranial expansive process, or structural anomaly, and absence of meningeal contrast enhancement in MRI without and with contrast product. A venous angio-MRI is necessary in atypical patients; if MRI is unavailable or contraindicated, a brain scan without and with contrast product can be done in combination with a venous angioscan with contrast injection * Normal CSF composition * High CSF opening pressure (≥ 25 cm of water) obtained from a lumbar puncture performed in lateral decubitus * For healthy volunteers No previous history of neurological or neurosurgical disorder Exclusion Criteria: * For all participants Pregnant or breastfeeding woman Contraindication to cerebral MRI: metallic implant, pacemaker, artificial heart valve, cerebral vascular malformation, aneurysm clips, metallic fragments, artificial implants, peripheral or neural pacemaker, insulin pump, intravenous catheter, epilepsy , metallic contraceptive device, claustrophobia, refusal to be informed in case of abnormal MRI (with a significant medical abnormality) Hypersensitivity to the active substance of the contrast agent or to any of the excipients (Sodium calcobutrol, Trometamol, 1N hydrochloric acid (pH adjustment), Water for injections) lumbar puncture in the month preceding the brain MRI Neurological tumoral, degenerative, vascular, inflammatory or progressive pathology Renal or hepatic impairment MRI with gadolinium injection performed in the 7 days preceding the inclusion visit Person subject to a measure of legal protection (safeguard of justice, curatorship, guardianship), deprived of liberty by judicial or administrative decision * For participants with IIH Participants with a probable but not definite diagnosis of IIH according to the Dandy modified criteria * For healthy volunteers Chronic headaches (\>15 days per month) Uncorrected and/or unlabeled visual symptoms (visual blurriness, diplopia, visual eclipses, papilledema, optic atrophy)
Where this trial is running
Paris, Ile de France
- Service de Neuroradiologie, Groupe Hospitalier Pitié Salpêtrière, Paris, France — Paris, Ile de France, France (Recruiting)
Study contacts
- Study coordinator: Stephanie Lenck, MD
- Email: stephanie.lenck@icm-institute.org
- Phone: +33(0)142163594
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.