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Completed

NCT Number: NCT04356599

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Montpellier, 34295, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Quantification of K1 parameter.

    Time frame: 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).

  2. Quantification of Ki parameter.

    Time frame: 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.

Secondary outcomes

  1. Delayed cerebral ischemic regions.

    Time frame: 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).

  2. Delayed spasmed arteries territories.

    Time frame: 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).

  3. Quantification of cerebral blood flow using DSC-MRI

    Time frame: 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)

  4. Quantification of cerebral blood flow using ASL-MRI

    Time frame: 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)

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study 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)

Acronym: PREDISP

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Apr 22, 2020
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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