DANTE SPACE for Evaluation of Subjects With Intracranial... | NCT05505071

Studies
DANTE SPACE for Evaluation of Subjects With Intracranial Vascular Disease

NCT05505071

Sponsor

University of North Carolina, Chapel Hill

Status

Withdrawn

Last Update Posted

Jan 5, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Intracranial Vascular Disease

Interventions

DANTE SPACE sequence

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI leaving institution and study will not be started.

Expanded Access Info

Start Date

Dec 2022Estimated

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Aug 15, 2022

First Submission Date that Met QC Criteria

Aug 15, 2022

First Posted Date

Aug 17, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2023

Last Update Posted Date

Jan 5, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DANTE SPACE MRI Sequence	Experimental	Participants will receive an additional DANTE SPACE sequence with their clinical MRI	Device: DANTE SPACE sequence

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DANTE SPACE sequence	Device	investigational MRI sequence less than 15 minutes	DANTE SPACE MRI Sequence

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mahmud Mossa-Basha, MD	University of North Carolina, Chapel Hill	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

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).

Types

Study Protocol

Time Frame

Beginning 9 months after and continuing for 36 months following publication

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.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002561	Cerebrovascular Disorders

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided