Stationary Head CT for Head Trauma

Recruiting in Palo Alto (17 mi)

Overseen byCarlos Zamora, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of North Carolina, Chapel Hill

No Placebo Group

Trial Summary

What is the purpose of this trial?

Purpose: The purpose of this study is to evaluate stationary head CT (s-HCT) as a diagnostic tool in patients with known head trauma. Participants: Participants will be 50 people who have had either a head trauma or a brain bleed and have undergone a head CT in the past 24 hours or who will undergo a CT scan of the head. Procedures (methods): This investigation will be a single arm, prospective clinical trial. Participants will have one single visit, which will include the s-HCT scan. No follow-up is required. All images will be de-identified before inclusion within a reader study. The investigators will perform a reader study with physician readers comparing the acquired imaging s-HCT images and conventional head CT.

Research Team

Carlos Zamora, MD, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for adults over 18 who have experienced head trauma or a brain bleed, are medically stable, and can give written consent. They must have had a conventional head CT scan at UNC hospitals within the last day or be scheduled to get one.

Inclusion Criteria

Willing and able to provide written informed consent

I am 18 years old or older.

You have had a head CT scan at UNC hospitals in the last 24 hours or are going to have one soon.

See 1 more

Exclusion Criteria

Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine β-HCG results, obtained within 24 hours prior to the research scan, or on the basis of patient history, e.g., tubal ligation, hysterectomy or a minimum of 1 year without menses)

I am unable to give consent by myself.

You are currently breastfeeding.

Treatment Details

Interventions

Stationary Head CT (s-HCT) (Imaging)

Trial OverviewThe study is testing a new type of stationary head CT (s-HCT) as a diagnostic tool for patients with traumatic brain injuries. It's a single-visit study without follow-up where images from s-HCT will be compared to those from regular CT scans by physician readers.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Head Trauma or Brain BleedExperimental Treatment1 Intervention

Medically stable patients who have undergone conventional head CT imaging undergo imaging within 24 hours using the s-HCT system.