DANTE SPACE for Evaluation of Subjects With Intracranial Vascular Disease

NCT ID: NCT05505071

Last Updated: 2023-01-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2023-12-31

Brief Summary

Purpose: The purpose of this study is to evaluate the Delay Alternating with Nutation for Tailored Excitation (DANTE) SPACE sequence in clinical studies to determine whether it can provide more useful information for clinical diagnosis.

Participants: 100 participants with concern for intracranial vascular disease scheduled to undergo a clinical vessel wall MRI will be recruited.

Procedures (methods): Patients with concern for intracranial vascular disease scheduled to undergo a clinical vessel wall MRI who will have an additional non-FDA approved sequence (DANTE SPACE) added to their clinical scan. The investigational sequence requires less than 15 minutes and will be added following the standard MRI sequence.

Conditions

Intracranial Vascular Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

DANTE SPACE MRI Sequence

Participants will receive an additional DANTE SPACE sequence with their clinical MRI

Group Type: EXPERIMENTAL

DANTE SPACE sequence

Intervention Type: DEVICE

investigational MRI sequence less than 15 minutes

Interventions

DANTE SPACE sequence

investigational MRI sequence less than 15 minutes

Intervention Type: DEVICE

Other Intervention Names

Delay Alternating with Nutation for Tailored Excitation (DANTE)

Eligibility Criteria

Inclusion Criteria

• Ages 18 and older
• Concern for intracranial vascular disease
• Scheduled to undergo a clinical vessel wall MRI

Exclusion Criteria

• Claustrophobia
• Implanted metallic devices, parts, vascular clips, or other foreign bodies.
• Known hypersensitivity to gadolinium contrast or to any component of gadolinium contrast refractory to standard medications (antihistamines, steroids)
• Impaired kidney function (serum creatinine level > 1.8 mg/dL or a glomerular filtration rate < 60 as approximated using serum creatinine levels) unless anuric and on dialysis.
• Any woman who is pregnant or has reason to believe she is pregnant via self report

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mahmud Mossa-Basha, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Other Identifiers

22-2096

Identifier Type: -

Identifier Source: org_study_id