Intracerebral Haemorrhage, ICHTIPITCH-7TNCT07789990
Characterization of Peri-Hemorrhagic Cerebral Edema Using Synthetic Sodium Imaging With 7-Tesla and 3-Tesla MRI
A study testing Sodium tissue concentration will be measured in perihematomal oedema in people with Intracerebral Haemorrhage, ICH, run by University Hospital, Lille.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracerebral Haemorrhage, ICH
- What is being tested?
- Sodium tissue concentration will be measured in perihematomal oedema
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Grégory KUCHCINSKI Hospital Practitioner, MD,PhD contact
About this study
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
- Being tested
- Sodium tissue concentration will be measured in perihematomal oedema
- Keywords
- Magnetic Resonance Imaging, Sodium, Artificial Intelligence, Stroke, Intracerebral hemorrhage, Oedema
- Medical subject headings
- Cerebral Hemorrhage, Hepatitis, Infectious Canine, Stroke, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium tissue concentration will be measured in perihematomal oedemaDevice
Sodium tissue concentration will be measured in perihematomal oedema
| Study group | Role | What they receive |
|---|---|---|
| 7Tesla Sodium MRI | Experimental | Not described Receives: Device: Sodium tissue concentration will be measured in perihematomal oedema |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 6-month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion15 Sep 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral Haemorrhage, ICHStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Lille University, Lille In vivo Imaging and Functional Exploration
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789990
- Sponsor's protocol ID
- 2025_0664
- Acronym
- TIPITCH-7T
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Peri-Hemorrhagic Cerebral Edema Using Synthetic Sodium Imaging With 7-Tesla and 3-Tesla MRI
- ClinicalTrials.gov ID
- NCT07789990
- Acronym / sponsor ID
- TIPITCH-7T / 2025_0664
- Conditions
- Intracerebral Haemorrhage, ICH
- Keywords
- Magnetic Resonance Imaging, Sodium, Artificial Intelligence, Stroke, Intracerebral hemorrhage, Oedema
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Lille University, Lille In vivo Imaging and Functional Exploration
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 15 Sep 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 7Tesla Sodium MRI | Experimental | Device: Sodium tissue concentration will be measured in perihematomal oedema |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium tissue concentration will be measured in perihematomal oedemaSodium tissue concentration will be measured in perihematomal oedema | Device | 7Tesla Sodium MRI |
Primary outcome
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.
1 secondary outcome
Correlation coefficients of 6-month disability degree and sodium concentration.
Time frame: Baseline and 6-month visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Grégory KUCHCINSKI Hospital Practitioner, MD,PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Sodium tissue concentration will be measured in perihematomal oedema in people with Intracerebral Haemorrhage, ICH, run by University Hospital, Lille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grégory KUCHCINSKI Hospital Practitioner, MD,PhD (0320446468 ext. +33, gregory.kuchcinski@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraclass coefficient correlation (ICC) (time frame: Baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.