Characterization of Peri-Hemorrhagic Cerebral Edema Using Synthetic Sodium Imaging With 7-Tesla and 3-Tesla MRI

NCT07789990 | Not Yet Recruiting

• 1 other identifier: 2025_0664
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

Intracerebral haemorrhage is the type of stroke with the highest mortality rate, estimated at 40% in the acute phase. Among survivors, half will experience functional disability. Currently, there is no validated effective treatment. Reduction of perihematomal oedema is a potential therapeutic target. The development of oedema in the days following the haemorrhage worsens functional prognosis, notably through a harmful inflammatory process. In the early phase, neuronal excitotoxicity induced by the hematoma plays a major role in triggering the inflammatory cascade. This phenomenon is associated with dysfunction of neuronal Na⁺/K⁺ ATPase pumps and a disturbance of cerebral sodium homeostasis. Ultra-high field 7T MRI enables in vivo quantification of brain sodium concentrations. We hypothesize that a drop-in sodium concentration within the perihematomal oedema is associated with greater oedema expansion and poorer functional outcome. To make this biomarker accessible to centers without 7 Tesla MRI, we will use an artificial intelligence algorithm to generate synthetic sodium concentration maps derived from data acquired on conventional 3 Tesla MRI.

Conditions

Intracerebral Haemorrhage, ICH

Keywords

Magnetic Resonance Imaging; Sodium; Artificial Intelligence; Stroke; Intracerebral hemorrhage; Oedema

Outcome Measures

Primary Outcomes (1)

• Intraclass coefficient correlation (ICC)

  Intraclass coefficient correlation (ICC) between sodium concentration measured at 7T and synthetic sodium concentration calculated from 3T images assessed at day-8 after ICH onset.

  Baseline visit

Secondary Outcomes (1)

• Correlation coefficients of 6-month disability degree and sodium concentration.

  Baseline and 6-month visit

Study Arms (1)

7Tesla Sodium MRI

EXPERIMENTAL

Device: Sodium tissue concentration will be measured in perihematomal oedema

Interventions

Sodium tissue concentration will be measured in perihematomal oedema DEVICE

Sodium tissue concentration will be measured in perihematomal oedema

7Tesla Sodium MRI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 18 and 80 years old;
• presenting for a first-ever or recurrent symptomatic supratentorial spontaneous ICH within 8 (±2) days after symptoms onset (or last seen well) and confirmed by brain imaging; presumed to be related to small vessel disease.
• Patient/legal representative/trusted person who has given written consent to participate in the trial;
• Patient covered by social security in France
• Patient willing to comply with all study procedures and its duration

You may not qualify if:

• Contra-indication for MRI;
• pre-admission disabilities (mRs \> 4);
• large ICH of 60 ml or more;
• NIH Stroke Scale score \> 20;
• item 1a of NIH Stroke Scale (level consciousness) \> 0;
• surgical evacuation of ICH, associated intraventricular haemorrhage; ICH due to preceding trauma; ICH suspected to result from an identified intracranial vascular malformation, intracranial venous thrombosis, tumor or haemorrhagic transformation within an infarct.
• Patient in the intensive care unit who is intubated and on a ventilator
• Pregnancy

Sponsors & Collaborators

• University Hospital, Lille: lead
• Lille University - Lille In vivo Imaging and Functional Exploration: collaborator

MeSH Terms

Conditions

Cerebral Hemorrhage; Hepatitis, Infectious Canine; Stroke; Edema

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatitis, Viral, Animal; Hepatitis, Animal; Infections; Adenoviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis; Liver Diseases; Digestive System Diseases; Dog Diseases; Animal Diseases; Signs and Symptoms

Central Study Contacts

Grégory KUCHCINSKI Hospital Practitioner, MD,PhD

CONTACT

0320446468; gregory.kuchcinski@chu-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 15, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share