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DANTE SPACE for Evaluation of Subjects With Intracranial Vascular Disease

DANTE SPACE for Evaluation of Subjects With Intracranial Vascular Disease

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05505071
Enrollment
0
Registered
2022-08-17
Start date
2022-12-31
Completion date
2023-12-31
Last updated
2023-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Vascular Disease

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.

Interventions

DEVICEDANTE SPACE sequence

investigational MRI sequence less than 15 minutes

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical Utility for Visualizing PathologyBaselineThe primary objective is to determine the percent of participants with a visible region of interest.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026