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NCT Number: NCT05026060

Measurement of Brain Perfusion by a MR Perfusion Imaging Called eASL in Children's Cerebral Arteriopathies.

The MR sequence called MR-ASL is used to measure cerebral perfusion in children. This ASL sequence is used with a unique post-labeling delay (PLD) due to the technical impossibility of setting different post-labeling delays. The use of a single post-labeling, chosen by the pediatric radiology department of the Necker hospital, optimal in children without arteriopathy, may not be suitable for the lengthened arterial transit time of the spins marked in the pathological carotid network of a child with arterial disease.

Recently, ASL sequences with multiple delays (multi-PLD, called eASL) have been developed to overcome this limitation in arterial disease. To date, their use in the pre- and post-treatment evaluation of a child with acute or chronic arterial disease has not been evaluated.

The study hypothesis is that this eASL sequence is more efficient than single-delay ASL in measuring cerebral perfusion. The study will be performed in a population of children with acute or chronic arterial disease.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

For 9 years, the pediatric radiology department of the Necker Enfants Malades hospital has routinely used an MR sequence called MR-ASL, which has made it possible to measure cerebral perfusion in children. The service was a pioneer in using this sequence in children and it made it possible to detect areas of cerebral hypo-perfusion (or even pathological hyper-perfusion) and also to monitor post-surgical or spontaneous revascularizations. But this technique suffers from some limitations. Indeed, this ASL sequence is used with a unique post-labeling delay (PLD) of 1025 ms due to the technical impossibility of setting different post-labeling delays. This PLD corresponds to the arterial transit time of the spins marked to have a satisfactory cerebral perfusion. The use of a single post-labeling, chosen short (1025 ms) by the pediatric radiology department of the Necker hospital, optimal in children without arterial disease, may not be suitable for arterial transit time elongated spins marked in the pathological carotid network of a child with arterial disease.

Recently, ASL sequences with multiple delays (multi-PLD, called eASL) have been developed to overcome this limitation in arterial disease. To date, their use in the pre- and post-treatment evaluation of a child with acute or chronic arterial disease has not been evaluated.

The eASL is a sequence that lasts 4 minutes without injection of contrast product that the pediatric radiology department at Necker Hospital intends to add to the standard clinical sequences, as part of this study. This sequence will have no post-labeling delay a priori and will make it possible to test several post-labeling delays in one go. Thus, no a priori hypothesis on the transit time of the spins will be made and the eASL sequence will be able to show, after its reconstruction, what is the optimal post-labeling delay.

The study will be performed in a population of children with acute or chronic arterial disease. The study hypothesis is that this eASL sequence is more efficient than single-delay ASL in measuring cerebral perfusion.

Who can participate

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

Inclusion criteria

  • Minor patients aged 0 to 18 with acute or chronic arterial disease: diagnosis of Moya-moya, diagnosis of sickle cell disease, acute and chronic arterial infarction.
  • Necessity of diagnostic MR with standard ASL sequences for the care.
  • Holders of parental authority and patients informed and not opposed to their participation in the study.

Exclusion criteria

  • Usual contraindications to MR.
  • Movement during ASL / eASL sequences.

Treatment and study plan

Imaging

Diagnostic Test

4-minutes eASL sequence without injection of contrast product added to each of the clinical MRs with standard ASL sequences performed for the care of the patient for 3 years.

Other names: eASL sequence

Primary outcomes

  1. Qualitative analysis of regional cerebral blood flow (CBF) in ASL and eASL based on a visual analysis of rainbow colored maps

    Time frame: 3 years

    In each parametric CBF map (ASL and eASL), brain regions appearing visually hypo- or hyperperfused compared to other brain regions will be recorded.

  2. Quantitative analysis of regional cerebral blood flow (CBF) in ASL and eASL using Regions of Interest (ROIs)

    Time frame: 3 years

    In each parametric CBF map (ASL and eASL), the regional CBF will be measured in ml/100g/min over all brain regions by ROIs.

  3. Quantitative analysis of regional cerebral blood flow (CBF) using statistical parametric map (SPM)

    Time frame: 3 years

    In each SPM processed CBF parametric map (ASL and eASL), regions with statistically significant hypo- or hyperflow compared to other regions will be recorded.

Secondary outcomes

  1. Qualitative analysis of regional cerebral blood flow (CBF) change before and after surgical or spontaneous revascularization in ASL and eASL based on a visual analysis of rainbow colored maps

    Time frame: 3 years

    For each ASL sequence (ASL and eASL), pre-and post-revascularization parametric CBF maps will be displayed and co-registered. Brain regions visually showing variation in CBF after reperfusion compared with brain areas clear of acute or chronic arterial disease will be recorded.

  2. Quantitative analysis of regional cerebral blood flow (CBF) variation before and after surgical or spontaneous revascularization in ASL and eASL using Regions of Interest (ROI)

    Time frame: 3 years

    For each ASL sequence (ASL and eASL), pre- and post-revascularization parametric CBF maps will be displayed and co-registered. In each brain region, the difference in CBF before and after revascularization (in ml/100g/min) will be measured using ROIs.

  3. Quantitative analysis of regional cerebral blood flow (CBF) change before and after surgical or spontaneous revascularization in ASL and eASL unsing statistical parametric map (SPM)

    Time frame: 3 years

    Each ASL sequence (ASL and eASL) will be post-processed in SPM. Regions with a statistically significant change in CBF before and after revascularization will be recorded.

  4. Optimal post-labeling delay

    Time frame: 3 years

    Calculation of optimal post-labeling delay (PLD) according to the type of arterial disease.

    Regional measures on the arterial transit time map.

Study contacts

Contact information is provided by the study sponsor or research team.

Hélène Morel

CONTACT

[email protected]

1 44 38 16 53 ext. +33

Nathalie BODDAERT, MD, PhD

CONTACT

[email protected]

1 71 39 65 30 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Measurement of Brain Perfusion by a Magnetic Resonance (MR) Perfusion Imaging Called eASL in Children's Cerebral Arteriopathies.

Acronym: PEACE

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Aug 30, 2021
Registry last updated
Sep 15, 2025

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.