NCT07789990Not yet recruiting
Characterization of Peri-Hemorrhagic Cerebral Edema Using Synthetic Sodium Imaging With 7-Tesla and 3-Tesla MRI
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
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. The investigators 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, the investigators will use an artificial intelligence algorithm to generate synthetic sodium concentration maps derived from data acquired on conventional 3 Tesla MRI.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 24 Aug 2026
- Start date
- Sept 2026
- Primary completion date
- Sept 2028
- Lead sponsor
- University Hospital, Lille
- Diseases
- Stroke
- NCT number
- NCT07789990
What you commit to
- Study type: Interventional
- Planned participants: 48
- From Sept 2026 to the primary completion date, Sept 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Epileptic seizure within 48 hours prior to inclusion or anti-epileptic treatment
Other illness
- 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.
Other
- Contra-indication for MRI;
- pre-admission disabilities (mRs \> 4);
- large ICH of 60 ml or more;
- Patient in the intensive care unit who is intubated and on a ventilator
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.