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

NCT ID: NCT04356599

Last Updated: 2024-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-22
• Study Completion Date: 2024-02-19

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).

Conditions

Aneurysmal Subarachnoid Haemorrhage

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention Group

All participants will receive study intervention

Group Type: EXPERIMENTAL

Early dynamic 18F-FDG PET/CT assessment of cerebral glucose uptake

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kévin CHALARD, M.D.

Role: PRINCIPAL_INVESTIGATOR

UH Montpellier

Locations

Département d'Anesthésie-Réanimation Gui de Chauliac 80 Av Augustin.Fliche

Montpellier, , France

Countries

France

Other Identifiers

RECHMPL19_0408

Identifier Type: -

Identifier Source: org_study_id