Prediction of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage Using Dynamic 18F-FDG PET/CT

Aneurysmal Subarachnoid Haemorrhage Clinical Trial

— PREDISP  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04356599
• Other study ID #: RECHMPL19_0408
• Status: Completed
• Phase: N/A
• Start date: July 22, 2020
• Est. completion date: February 19, 2024

Study information

• Verified date: May 2024
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 19, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Haemorrhage
• Brain Ischemia
• Cerebral Infarction
• Hemorrhage
• Ischemia
• Subarachnoid Hemorrhage

Intervention

Other:
• Early dynamic 18F-FDG PET/CT assessment of cerebral glucose uptake
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.

Locations

Country	Name	City	State
France	Département d'Anesthésie-Réanimation Gui de Chauliac 80 Av Augustin.Fliche	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Day 2 +/- 1 day after the initial bleeding
Primary	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.	Day 2 +/- 1 day after the initial bleeding
Secondary	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).	From day 2 to day 21 +/- 3 days after the initial bleeding
Secondary	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).	From day 2 to day 21 +/- 3 days after the initial bleeding
Secondary	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)	At day 4 +/- 1 day after the initial bleeding
Secondary	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)	At day 4 +/- 1 day after the initial bleeding
Secondary	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.	At day 4 +/- 1 day after the initial bleeding
Secondary	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.	At day 4 +/- 1 day after the initial bleeding