Aneurysmal Subarachnoid HaemorrhagePREDISPNCT04356599
Prediction of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage Using Dynamic 18F-FDG PET/CT
A study testing Early dynamic 18F-FDG PET/CT assessment of cerebral glucose uptake in people with Aneurysmal Subarachnoid Haemorrhage, run by University Hospital, Montpellier at 1 site in France.
Trial summary
A pilot trial for assessing early microvascular alterations after aneurysmal subarachnoid hemorrhage using dynamic 18F-FDG PET/CT. The primary endpoint will be the measure of early changes in cerebral glucose uptake reflecting microperfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysmal Subarachnoid Haemorrhage
- What is being tested?
- Early dynamic 18F-FDG PET/CT assessment of cerebral glucose uptake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jul 2020to 19 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent to participate in the study must be obtained from the subject or proxy/legal representative prior to enrollment.
- males and females aged 18 years and older.
- SAH proven by computed tomography (CT) and that has occurred within the last 72 hours.
- ruptured saccular aneurysm angiographically confirmed by digital subtraction angiogram or CT angiogram, which has been successfully secured by surgical clipping or endovascular coiling.
- high-risk subjects for DCI: "thick clot" on the hospital admission CT (grade 3 or grade 4 on the modified Fisher Scale).
- a woman of childbearing potential is eligible only if the serum pregnancy test performed during the screening period is negative.
Who cannot join
- PET/CT contradications
- MRI contradications
- gadolinium or meglumine hypersensitivity
- glomerular filtration rate <30mL/min
- SAH due to other causes than ruptured saccular aneurysm.
- post-HSA cardiac arrest.
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- high sustained ICP ( >20mmHg lasting >20min) despite optimal treatment.
- significant and concomitant organ failure amongst the following: hypotension with systolic blood pressure <90mmHg refractory to treatment; unresolved pulmonary edema or pneumonia with severe hypoxia defined as PaO2/FiO2 <150; severe cardiac failure requiring inotropic support.
- patients with "do-not-resuscitate" orders, withdrawal of care situation, dying patient.
- vulnerable patient populations (minor, legal vulnerability, prisoner)
- pregnant and nursing mothers.
Trial locations and contacts
1 site in 1 country.
France1 site
Département d'Anesthésie-Réanimation Gui de Chauliac 80 Av Augustin.Fliche
Montpellier, Montpellier, 34295
About this study
Official title: Prediction and Unraveling of Delayed Cerebral Ischemia in Patients With Subarachnoid Hemorrhage Using Early Dynamic 18F-FDG PET/CT Assessment of Cerebral Glucose Uptake (PREDISP)
A pilot trial for assessing early microvascular alterations after aneurysmal subarachnoid hemorrhage using dynamic 18F-FDG PET/CT. The primary endpoint will be the measure of early changes in cerebral glucose uptake reflecting microperfusion.
Read the detailed description
We hypothesize that an early irreversible microvascular deterioration following initial bleeding could contribute to DCI occurrence. More precisely, we suspect that DCI areas are somehow overlaps of regions in which microperfusion is precociously altered, shortening circulatory reserves, and territories of secondarily spasmed arteries further lowering blood flow, resulting in ischemia. We aim to explore the potential microvasculature alteration through cerebral glucose perfusion and metabolism assessment using early dynamic 18F-fluorodesoxyglucose Positron Emission Tomography/Computer Tomography (dynamic 18F-FDG PET/CT). If our hypothesis turned out to be valid, we would at the same time be able to determine risk factors for this unpredictable complication and gain remarkable insight into DCI pathophysiology. Thus, the purpose of this trial is to demonstrate, in patients affected by SAH, the correlation between early cerebral glucose uptake defects in 18F-FDG PET/CT and delayed cerebral infarction in magnetic resonance imaging (MRI).
- Conditions
- Aneurysmal Subarachnoid Haemorrhage
- Being tested
- Early dynamic 18F-FDG PET/CT assessment of cerebral glucose uptake
- Keywords
- Aneurysmal subarachnoid haemorrhage, Delayed Cerebral Ischemia, Positron emission tomography, Cerebral microcirculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early dynamic 18F-FDG PET/CT assessment of cerebral glucose uptakeOther
The intervention will consist in a dynamic cerebral 18F-FDG PET study performed at D2+/-1. Kinetic modeling will be performed using in-house software at the global, regional, and voxel level. In addition, cerebral perfusion and blood-brain-barrier permeability will be assessed at D4+/- 1 using perfusion MRI and permeability MRI.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | All participants will receive study intervention Receives: Other: Early dynamic 18F-FDG PET/CT assessment of cerebral glucose uptake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of K1 parameter.
A kinetic modeling for cerebral glucose uptake will be performed using in-house software in order to provide the K1 parameter (in min-1) in every voxel reflecting the cerebral blood flow (in mL/min).
Measured: Day 2 +/- 1 day after the initial bleeding
Quantification of Ki parameter.
A kinetic modeling for cerebral glucose uptake will be performed using in-house software in order to provide the Ki parameter (in min-1) in every voxel reflecting the cerebral metabolic rate of glucose in µmol/100g/min.
Measured: Day 2 +/- 1 day after the initial bleeding
Secondary outcomes (6)
Delayed cerebral ischemic regions.
Delayed cerebral ischemic lesions will be ascertained by routine MRI scans until the end of the period of time in which the subject may present DCI (D21+/-3).
Measured: From day 2 to day 21 +/- 3 days after the initial bleeding
Delayed spasmed arteries territories.
Occurence of vasospasm will be determined on routine angiograms until the end of the period of time in which the subject may present vasospasm (D21+/-3).
Measured: From day 2 to day 21 +/- 3 days after the initial bleeding
Quantification of cerebral blood flow using DSC-MRI
Cerebral blood flow in mL/100g/min will be measured using DSC-MRI (Dynamic Susceptibility Contrast Magnetic Resonance Imaging)
Measured: At day 4 +/- 1 day after the initial bleeding
Quantification of cerebral blood flow using ASL-MRI
Cerebral blood flow in mL/100g/min will be measured using ASL-MRI (Arterial Spin Labelling Magnetic Resonance Imaging)
Measured: At day 4 +/- 1 day after the initial bleeding
Quantification of blood-brain-barrier permeability using DSC-MRI
The blood-brain barrier permeability will be measured using DSC-MRI. A kinetic modeling will be performed in order to provide the leakage parameter K2 (in min-1) in every voxel.
Measured: At day 4 +/- 1 day after the initial bleeding
Quantification of blood-brain-barrier permeability using DCE-MRI
The blood-brain barrier permeability will be measured using DCE-MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging). A kinetic modeling will be performed in order to provide the leakage parameter Ktrans (in min-1) in every voxel.
Measured: At day 4 +/- 1 day after the initial bleeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start22 Jul 2020
- Primary completion1 Feb 2024
- Study completion19 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aneurysmal Subarachnoid HaemorrhageStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kévin CHALARD, M.D., Principal investigator, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356599
- Sponsor's protocol ID
- RECHMPL19_0408
- Acronym
- PREDISP
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2020
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Szabo V, Baccialone S, Kucharczak F, Dargazanli C, Garnier O, Pavillard F, Molinari N, Costalat V, Perrigault PF, Chalard K. CT perfusion-guided administration of IV milrinone is associated with a reduction in delayed cerebral infarction after subarachnoid hemorrhage. Sci Rep. 2024 Jun 27;14(1):14856. doi: 10.1038/s41598-024-65706-w.
PubMed 38937568
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction and Unraveling of Delayed Cerebral Ischemia in Patients With Subarachnoid Hemorrhage Using Early Dynamic 18F-FDG PET/CT Assessment of Cerebral Glucose Uptake (PREDISP)
- ClinicalTrials.gov ID
- NCT04356599
- Acronym / sponsor ID
- PREDISP / RECHMPL19_0408
- Conditions
- Aneurysmal Subarachnoid Haemorrhage
- Keywords
- Aneurysmal subarachnoid haemorrhage, Delayed Cerebral Ischemia, Positron emission tomography, Cerebral microcirculation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 19 Feb 2024 (actual)
- First posted
- 22 Apr 2020 (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.
A pilot trial for assessing early microvascular alterations after aneurysmal subarachnoid hemorrhage using dynamic 18F-FDG PET/CT. The primary endpoint will be the measure of early changes in cerebral glucose uptake reflecting microperfusion.
Detailed description
We hypothesize that an early irreversible microvascular deterioration following initial bleeding could contribute to DCI occurrence. More precisely, we suspect that DCI areas are somehow overlaps of regions in which microperfusion is precociously altered, shortening circulatory reserves, and territories of secondarily spasmed arteries further lowering blood flow, resulting in ischemia. We aim to explore the potential microvasculature alteration through cerebral glucose perfusion and metabolism assessment using early dynamic 18F-fluorodesoxyglucose Positron Emission Tomography/Computer Tomography (dynamic 18F-FDG PET/CT). If our hypothesis turned out to be valid, we would at the same time be able to determine risk factors for this unpredictable complication and gain remarkable insight into DCI pathophysiology. Thus, the purpose of this trial is to demonstrate, in patients affected by SAH, the correlation between early cerebral glucose uptake defects in 18F-FDG PET/CT and delayed cerebral infarction in magnetic resonance imaging (MRI).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Early dynamic 18F-FDG PET/CT assessment of cerebral glucose uptakeAll participants will receive study intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- written informed consent to participate in the study must be obtained from the subject or proxy/legal representative prior to enrollment.
- males and females aged 18 years and older.
- SAH proven by computed tomography (CT) and that has occurred within the last 72 hours.
- ruptured saccular aneurysm angiographically confirmed by digital subtraction angiogram or CT angiogram, which has been successfully secured by surgical clipping or endovascular coiling.
- high-risk subjects for DCI: "thick clot" on the hospital admission CT (grade 3 or grade 4 on the modified Fisher Scale).
Key exclusion criteria (11 listed)
- PET/CT contradications
- MRI contradications
- gadolinium or meglumine hypersensitivity
- glomerular filtration rate <30mL/min
- SAH due to other causes than ruptured saccular aneurysm.
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 |
|---|---|---|
| Early dynamic 18F-FDG PET/CT assessment of cerebral glucose uptakeThe intervention will consist in a dynamic cerebral 18F-FDG PET study performed at D2+/-1. Kinetic modeling will be performed using in-house software at the global, regional, and voxel level. In addition, cerebral perfusion and blood-brain-barrier permeability will be assessed at D4+/- 1 using perfusion MRI and permeability MRI. | Other | Intervention Group |
Primary outcome
Quantification of K1 parameter.
Time frame: Day 2 +/- 1 day after the initial bleeding
A kinetic modeling for cerebral glucose uptake will be performed using in-house software in order to provide the K1 parameter (in min-1) in every voxel reflecting the cerebral blood flow (in mL/min).
Quantification of Ki parameter.
Time frame: Day 2 +/- 1 day after the initial bleeding
A kinetic modeling for cerebral glucose uptake will be performed using in-house software in order to provide the Ki parameter (in min-1) in every voxel reflecting the cerebral metabolic rate of glucose in µmol/100g/min.
6 secondary outcomes
Delayed cerebral ischemic regions.
Time frame: From day 2 to day 21 +/- 3 days after the initial bleeding
Delayed spasmed arteries territories.
Time frame: From day 2 to day 21 +/- 3 days after the initial bleeding
Quantification of cerebral blood flow using DSC-MRI
Time frame: At day 4 +/- 1 day after the initial bleeding
Quantification of cerebral blood flow using ASL-MRI
Time frame: At day 4 +/- 1 day after the initial bleeding
Quantification of blood-brain-barrier permeability using DSC-MRI
Time frame: At day 4 +/- 1 day after the initial bleeding
Quantification of blood-brain-barrier permeability using DCE-MRI
Time frame: At day 4 +/- 1 day after the initial bleeding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Results publication: PubMed 38937568Szabo V, Baccialone S, Kucharczak F, Dargazanli C, Garnier O, Pavillard F, Molinari N, Costalat V, Perrigault PF, Chalard K. CT perfusion-guided administration of IV milrinone is associated with a reduction in delayed cerebral infarction after subarachnoid hemorrhage. Sci Rep. 2024 Jun 27;14(1):14856. doi: 10.1038/s41598-024-65706-w.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Kévin CHALARD, M.D. principal investigator
UH Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early dynamic 18F-FDG PET/CT assessment of cerebral glucose uptake in people with Aneurysmal Subarachnoid Haemorrhage, run by University Hospital, Montpellier at 1 site in France.
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 6 inclusion and 11 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: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of K1 parameter. (time frame: Day 2 +/- 1 day after the initial bleeding). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04356599, which also lists 1 linked publication.
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 6 May 2026.