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

Primary Purpose

Aneurysmal Subarachnoid Haemorrhage

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

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

About this trial

This is an interventional other trial for Aneurysmal Subarachnoid Haemorrhage focused on measuring Aneurysmal subarachnoid haemorrhage, Delayed Cerebral Ischemia, Positron emission tomography, Cerebral microcirculation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Group

Arm Description

All participants will receive study intervention

Outcomes

Primary Outcome Measures

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).

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.

Secondary Outcome Measures

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).

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).

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)

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)

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.

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.

Full Information

NCT ID

NCT04356599

First Posted

April 15, 2020

Last Updated

January 24, 2023

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT04356599

Brief Title

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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 22, 2020 (Actual)

Primary Completion Date

July 2024 (Anticipated)

Study Completion Date

August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aneurysmal Subarachnoid Haemorrhage

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

All participants will receive study intervention

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Quantification of K1 parameter.

Description

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).

Time Frame

Day 2 +/- 1 day after the initial bleeding

Title

Quantification of Ki parameter.

Description

Time Frame

Day 2 +/- 1 day after the initial bleeding

Secondary Outcome Measure Information:

Title

Delayed cerebral ischemic regions.

Description

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).

Time Frame

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

Title

Delayed spasmed arteries territories.

Description

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).

Time Frame

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

Title

Quantification of cerebral blood flow using DSC-MRI

Description

Cerebral blood flow in mL/100g/min will be measured using DSC-MRI (Dynamic Susceptibility Contrast Magnetic Resonance Imaging)

Time Frame

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

Title

Quantification of cerebral blood flow using ASL-MRI

Description

Cerebral blood flow in mL/100g/min will be measured using ASL-MRI (Arterial Spin Labelling Magnetic Resonance Imaging)

Time Frame

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

Title

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

Description

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.

Time Frame

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

Title

Quantification of blood-brain-barrier permeability using DCE-MRI

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kevin CHALARD, M.D.

Phone

788 014 588

Ext

+33

k-chalard@chu-montpellier.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Pierre-Francois PERRIGAULT, M.D.

pf-perrigault@chu-montpellier.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kévin CHALARD, M.D.

Organizational Affiliation

UH Montpellier

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Montpellier

ZIP/Postal Code

34295

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Oceane GARNIER, CRA

Phone

04 67 33 91 68

o-garnier@chu-montpellier.fr

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Time Frame

12 months after the main publication

IPD Sharing 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.

Learn more about this trial

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

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