Ireland
--:--IST
Recruiting Observational

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

NCT05026060 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2022-05-02
Last updated
2025-09-15

Condition(s) studied

Cerebral Arteriopathy

Investigational drug(s) / intervention(s)

Imaging

Imaging: 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
—
Max age
18 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Qualitative analysis of regional cerebral blood flow (CBF) in ASL and eASL based on a visual analysis of rainbow colored maps — 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.
  • Quantitative analysis of regional cerebral blood flow (CBF) in ASL and eASL using Regions of Interest (ROIs) — 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.
  • Quantitative analysis of regional cerebral blood flow (CBF) using statistical parametric map (SPM) — 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.

Trial sites (1)

FacilityCityRegionStatus
Hôpital Necker-Enfants Malades Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05026060 on ClinicalTrials.gov ↗ ← All trials in France