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

NCT07789990 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-09-01

No results posted yet for this study

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. 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.

Conditions

  • Intracerebral Haemorrhage, ICH

Interventions

DEVICE

Sodium tissue concentration will be measured in perihematomal oedema

Sodium tissue concentration will be measured in perihematomal oedema

Sponsors & Collaborators

  • Lille University

    collaborator OTHER

  • Lille In vivo Imaging and Functional Exploration

    collaborator UNKNOWN

  • University Hospital, Lille

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-09-15
Completion
2029-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07789990 on ClinicalTrials.gov