Back to resultsDANTE SPACE for Evaluation of Subjects With Intracranial Vascular Disease
Primary Purpose
Intracranial Vascular Disease
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DANTE SPACE sequence
Sponsored by
About this trial
This is an interventional diagnostic trial for Intracranial Vascular Disease
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DANTE SPACE MRI Sequence
Arm Description
Participants will receive an additional DANTE SPACE sequence with their clinical MRI
Outcomes
Primary Outcome Measures
Clinical Utility for Visualizing Pathology
The primary objective is to determine the percent of participants with a visible region of interest.
Secondary Outcome Measures
Full Information
NCT ID
NCT05505071
First Posted
August 15, 2022
Last Updated
January 3, 2023
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT05505071
Brief Title
DANTE SPACE for Evaluation of Subjects With Intracranial Vascular Disease
Official Title
DANTE SPACE for Evaluation of Subjects With Intracranial Vascular Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Why Stopped
PI leaving institution and study will not be started.
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Vascular Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DANTE SPACE MRI Sequence
Arm Type
Experimental
Arm Description
Participants will receive an additional DANTE SPACE sequence with their clinical MRI
Intervention Type
Device
Intervention Name(s)
DANTE SPACE sequence
Other Intervention Name(s)
Delay Alternating with Nutation for Tailored Excitation (DANTE)
Intervention Description
investigational MRI sequence less than 15 minutes
Primary Outcome Measure Information:
Title
Clinical Utility for Visualizing Pathology
Description
The primary objective is to determine the percent of participants with a visible region of interest.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmud Mossa-Basha, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC).
IPD Sharing Time Frame
Beginning 9 months after and continuing for 36 months following publication
IPD Sharing Access Criteria
The investigator who proposes to use the data has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Learn more about this trial
DANTE SPACE for Evaluation of Subjects With Intracranial Vascular Disease
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