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DANTE SPACE for Evaluation of Subjects With Intracranial Vascular Disease

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Withdrawn

Conditions

Intracranial Vascular Disease

Treatments

Device: DANTE SPACE sequence

Study type

Interventional

Funder types

Other

Identifiers

NCT05505071
22-2096

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

DANTE SPACE MRI Sequence
Experimental group
Description:
Participants will receive an additional DANTE SPACE sequence with their clinical MRI
Treatment:
Device: DANTE SPACE sequence

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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