Magnetic Resonance Imaging of Intracranial Vasculopathies

NCT03032809 | Unknown

• 1 other identifier: 2016P002505
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study are to optimize MR imaging and MR angiography sequences and image reconstruction for 3T magnetic resonance imaging system scanners, which are already used in the clinical environment on patients with or with suspected intracranial vasculopathies. Improvements in these areas will have positive implications for medical diagnosis and treatment.

Conditions

CNS Vasculitis

Outcome Measures

Primary Outcomes (1)

• Degree of intracranial artery vessel wall enhancement

  Degree of enhancement will be categorized as circumferential, eccentric, or absent

  During acute phase of symptoms (approximately 0-14 days from onset of symptoms)

Secondary Outcomes (1)

• Degree of intracranial artery vessel wall thickness

  During acute phase of symptoms (approximately 0-14 days from onset of symptoms)

Study Arms (1)

Intracranial vasculopathy

Patients diagnosed intracranial vasculopathy will be imaged further by high resolution vessel wall MR imaging on a 3Tesla MR scanner.

Other: Vessel Wall MR imaging

Interventions

Vessel Wall MR imaging OTHER

Magnetic resonance images of the intracranial arteries will be acquired using the 3 Tesla MR scanners. Intracranial vessels will be imaged by high resolution vessel wall MR imaging to characterize vessel wall enhancement characteristics and wall thickness.

Intracranial vasculopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Fifty (50) adult patients with intracranial vasculopathy will be enrolled.

You may qualify if:

• adult (older than 18 years)

You may not qualify if:

• electrical implants such as cardiac pacemakers or perfusion pumps
• ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
• ferromagnetic objects such as jewelry or metal clips in clothing
• pregnant subjects
• pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions
• any greater than normal potential for cardiac arrest

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Vasculitis, Central Nervous System

Condition Hierarchy (Ancestors)

Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Javier Romero, MD

CONTACT

6178402392; jmromero@mgh.harvard.edu

Emmanuel Obusez, MD

CONTACT

6177268320; EOBUSEZ@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiology

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 26, 2017
• Study Start: September 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: September 17, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)