NCT06392347

Brief Summary

The purpose of this study is to compare and evaluate a faster MR image that has been optimized to look at participants blood vessel walls.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
36mo left

Started Aug 2027

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
3.3 years until next milestone

Study Start

First participant enrolled

August 1, 2027

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

April 25, 2024

Last Update Submit

September 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Optimizing scan efficiency of T1-weighted (T1w) imaging for vessel wall imaging protocols

    The primary outcome of the study will be the raters study where qualitative imaging scores will be provided by experienced radiologists using a four-point scale.

    24 months

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The staff will be observant of issues related to undue influence as it relates to any vulnerable populations in the event, they are eligible and enrolled in the study (e.g. there will be no impact on grades, employment status, access to medical care or information). If employees, students, etc. meet the eligibility criteria and are enrolled we will do a thorough and sensitive informed consent process in order to protect their rights and minimize any risk of coercion or undue influence.

You may qualify if:

  • \. Patients 18 years of age and scheduled to undergo clinical vessel wall MR imaging exams as part of their standard of care.

You may not qualify if:

  • Any person under the age of 18
  • Presence of artifact-producing intracranial devices (aneurysm clips/coils, ventricular drains, craniectomy mesh, etc.)
  • Any person with contraindications to MRI (medical instability, non-MRI compatible implanted devices, retained metallic foreign bodies, claustrophobia)
  • Large space-occupying lesions (50 mL) or substantial mass effect (herniation, 5mm midline shift) on preceding brain imaging,
  • Imminently life-threatening co-morbid conditions
  • A history of premorbid disabling neurological or psychiatric disease, current substance abuse or remote substance abuse with permanent organic sequelae
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2024

First Posted

April 30, 2024

Study Start (Estimated)

August 1, 2027

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

July 1, 2030

Last Updated

September 8, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations