ClinicalTrials.gg
Not yet recruitingNCT07789990TIPITCH-7TUpdated Sep 1, 2026

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

An interventional study of Sodium tissue concentration will be measured in perihematomal oedema in Intracerebral Haemorrhage, ICH, sponsored by University Hospital, Lille. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

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.

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Conditions studied

  • Intracerebral Haemorrhage, ICH

Keywords

  • Magnetic Resonance Imaging
  • Sodium
  • Artificial Intelligence
  • Stroke
  • Intracerebral hemorrhage
  • Oedema
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In context

Cerebral Hemorrhage

457 studies on the registry are indexed under Cerebral Hemorrhage; 172 are open to participants now.

This study's planned enrollment of 48 is below the median of 100 across 269 interventional studies indexed under Cerebral Hemorrhage.

Browse Cerebral Hemorrhage studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    7Tesla Sodium MRI

    Device: Sodium tissue concentration will be measured in perihematomal oedema

Interventions

  • DeviceSodium tissue concentration will be measured in perihematomal oedema

    Sodium tissue concentration will be measured in perihematomal oedema

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What researchers measure

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.

    Time frame: Baseline visit

Secondary outcomes

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

    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.

    Time frame: Baseline and 6-month visit

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07789990
Collaborators
Lille University, Lille In vivo Imaging and Functional Exploration
Responsible party
Sponsor
First posted
Aug 27, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 15, 2028 (estimated)
Completion
Mar 1, 2029 (estimated)
Last update
Sep 1, 2026

Study contacts

Grégory KUCHCINSKI Hospital Practitioner, MD,PhD
Contact
gregory.kuchcinski@chu-lille.fr
0320446468 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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