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

NCT04356599 | Completed DMC

• 1 other identifier: RECHMPL19_0408
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Aneurysmal Subarachnoid Haemorrhage

Keywords

Aneurysmal subarachnoid haemorrhage; Delayed Cerebral Ischemia; Positron emission tomography; Cerebral microcirculation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Delayed cerebral ischemic regions.

  From day 2 to day 21 +/- 3 days after the initial bleeding

• Delayed spasmed arteries territories.

  From day 2 to day 21 +/- 3 days after the initial bleeding

• Quantification of cerebral blood flow using DSC-MRI

  At day 4 +/- 1 day after the initial bleeding

• Quantification of cerebral blood flow using ASL-MRI

  At day 4 +/- 1 day after the initial bleeding

• Quantification of blood-brain-barrier permeability using DSC-MRI

  At day 4 +/- 1 day after the initial bleeding

Study Arms (1)

Intervention Group

EXPERIMENTAL

All participants will receive study intervention

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

Interventions

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

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

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

Montpellier, Montpellier, 34295, France

Location

Related Publications (1)

• 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.

  PMID: 38937568 RESULT

Study Officials

• Kévin CHALARD, M.D.

  UH Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 22, 2020
• Study Start: July 22, 2020
• Primary Completion: February 1, 2024
• Study Completion: February 19, 2024
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 12 months after the main publication
• Access Criteria: Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and IRB review. Dataset will be shared after careful examination by the study board of investigators.

Locations

FR (1)