DANTE SPACE for Evaluation of Subjects With Intracranial Vascular Disease

Not Applicable

Withdrawn

• Conditions: Intracranial Vascular Disease
• Interventions: Device: DANTE SPACE sequence

• Registration Number: NCT05505071
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-08-15
• Study First Posted: 2022-08-17
• Status Verified: 2022-12
• Study Start: 2022-12
• Last Update Submitted: 2023-01-03
• Last Update Posted: 2023-01-05
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DANTE SPACE MRI Sequence	DANTE SPACE sequence	Participants will receive an additional DANTE SPACE sequence with their clinical MRI

Primary Outcome Measures

Name	Time	Method
Clinical Utility for Visualizing Pathology	Baseline	The primary objective is to determine the percent of participants with a visible region of interest.