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

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.

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Key information

Conditions

Intracerebral Haemorrhage, ICH Adenoviridae Infections Animal Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders DNA Virus Infections Digestive System Diseases Dog Diseases Edema Hemorrhage Hepatitis Hepatitis, Animal Hepatitis, Infectious Canine Hepatitis, Viral, Animal Infections Intracranial Hemorrhages Liver Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.
Epileptic seizure within 48 hours prior to inclusion or anti-epileptic treatment
Patient in the intensive care unit who is intubated and on a ventilator
Pregnancy

Treatment and study plan

Sodium tissue concentration will be measured in perihematomal oedema

Device

Sodium tissue concentration will be measured in perihematomal oedema

Primary outcomes

Intraclass coefficient correlation (ICC)

Time frame: Baseline visit

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.

Secondary outcomes

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

Time frame: Baseline and 6-month visit

Correlation coefficients of 6-month disability degree assessed by modified Rankin scale (mRS) with 7T and 3T synthetic sodium concentration at day-8 after ICH onset.

Study contacts

Contact information is provided by the study sponsor or research team.

Grégory KUCHCINSKI Hospital Practitioner, MD,PhD

CONTACT

[email protected]

0320446468 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

Lille University - Lille In vivo Imaging and Functional Exploration

Registry information

Acronym: TIPITCH-7T

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2029
First posted: Aug 27, 2026
Registry last updated: Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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