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

NCT05026060 | Recruiting

• 2 other identifiers: APHP2103392021-A00225-36
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Arteriopathy

Keywords

Children's cerebral arteriopathies; Brain perfusion; Magnetic resonance (MR) perfusion imaging; ASL sequence with multiple post-labeling delays (eASL)

Outcome Measures

Primary Outcomes (3)

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

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

  3 years

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

  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 years

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

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

  3 years

Secondary Outcomes (4)

• 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

  3 years

• 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)

  3 years

• 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)

  3 years

• Optimal post-labeling delay

  3 years

Study Arms (1)

Patients with arterial disease

Minor patients with acute or chronic arterial disease: diagnosis of Moyamoya, diagnosis of sickle cell disease, acute or chronic arterial infarction.

Diagnostic Test: Imaging

Interventions

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.

Also known as: eASL sequence

Patients with arterial disease

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute or chronic arterial disease followed at Necker hospital.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

RECRUITING

MeSH Terms

Interventions

Diagnostic Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Nathalie BODDAERT, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• David GREVENT, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Nathalie BODDAERT, MD, PhD

CONTACT

1 71 39 65 30; nathalie.boddaert@aphp.fr

Hélène Morel

CONTACT

1 44 38 16 53; helene.morel@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: August 30, 2021
• Study Start: May 2, 2022
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)