Prediction of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage Using Dynamic 18F-FDG PET/CT
- Conditions
- Aneurysmal Subarachnoid Haemorrhage
- Interventions
- Other: Early dynamic 18F-FDG PET/CT assessment of cerebral glucose uptake
- Registration Number
- NCT04356599
- Lead Sponsor
- University Hospital, Montpellier
- Brief 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Group Early dynamic 18F-FDG PET/CT assessment of cerebral glucose uptake All participants will receive study intervention
- Primary Outcome Measures
Name Time Method Quantification of Ki parameter. 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.
Quantification of K1 parameter. 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).
- Secondary Outcome Measures
Name Time Method Quantification of cerebral blood flow using DSC-MRI At day 4 +/- 1 day after the initial bleeding Cerebral blood flow in mL/100g/min will be measured using DSC-MRI (Dynamic Susceptibility Contrast Magnetic Resonance Imaging)
Delayed cerebral ischemic regions. From day 2 to day 21 +/- 3 days after the initial bleeding 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).
Quantification of cerebral blood flow using ASL-MRI At day 4 +/- 1 day after the initial bleeding Cerebral blood flow in mL/100g/min will be measured using ASL-MRI (Arterial Spin Labelling Magnetic Resonance Imaging)
Quantification of blood-brain-barrier permeability using DSC-MRI At day 4 +/- 1 day after the initial bleeding 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.
Quantification of blood-brain-barrier permeability using DCE-MRI At day 4 +/- 1 day after the initial bleeding 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.
Delayed spasmed arteries territories. From day 2 to day 21 +/- 3 days after the initial bleeding 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).
Trial Locations
- Locations (1)
Département d'Anesthésie-Réanimation Gui de Chauliac 80 Av Augustin.Fliche
🇫🇷Montpellier, France