3D Transcranial Ultrasound Brain Imaging (3D-TRUBI) Instrument for Point-of-Care Diagnosis of Intracranial Hemorrhages (3D-TRUBI)

3D Transcranial Ultrasound Brain Imaging (3D-TRUBI) Instrument for Point-of-Care Diagnosis of Intracranial Hemorrhages Caused by Traumatic Brain Injuries

The primary objective of this study is to assess the safety of the 3D Transcranial Ultrasound Brain Imaging (3D TRUBI) device in Traumatic Brain Injury (TBI) patients with intracranial hemorrhage (ICH). The secondary objective is to assess the diagnostic potential of 3D TRUBI. The latter will be achieved by comparison of 3D TRUBI scans with admission head computed tomography (CT), the standard of care diagnostic modality. Demonstrating the feasibility and safety of the 3D TRUBI system is the first step toward expanding access of an alternative to CT for diagnostic imaging and triage of mass casualties of war or natural disasters in the field and in rapidly deployed medical centers or other austere environments.

Study Overview

• Status: Active, not recruiting
• Conditions: Traumatic Brain Injury; Intracranial Hemorrhages; Traumatic Brain Hemorrhage; Ultrasound Exams; 3D SONOGRAPHY
• Intervention / Treatment: Device: 3D Transcranial Ultrasound Brain Imaging

Detailed Description

Eligible participants positive for intracranial hemorrhage (ICH) due to traumatic brain injury (TBI) will undergo a full scanning procedure by trained investigators. Examination with the 3D TRUBI system will involve acquisition of 16 pre-defined bilateral head points. The total time to complete the procedure is approximately 20 minutes. During the examination, feasibility and safety metrics will be collected. Additional injury data will be reviewed from participants' electronic medical record. The goal of the study is 1) to evaluate the safety of the 3D TRUBI device in the target population and 2) do demonstrate the feasibility of the device to detect ICH compared to standard medical imaging.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• United States
  • Texas
    • Ft. Sam Houston, Texas, United States, 78234
      • Brooke Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from qualifying Traumatic Brain Injuries accepted for care at Brooke Army Medical Center

Description

Inclusion Criteria:

• Age 18-89
• Acute head injury with CT-confirmed intracranial hemorrhage
• Able to obtain written, informed consent from participant or legally authorized representative
• Able to receive intervention within 4 hours of admission head CT
• Able to feasibly receive intervention prior to neurosurgical indication

Exclusion Criteria:

• Did not receive routine head CT
• Prisoner or Wards of State
• Large or open skull wounds prohibiting ultrasound acquisition
• Received large volume fluid resuscitation (e.g. >3 units of blood product) within 2 hours of intervention
• Any prohibiting condition or contraindication for ultrasound image acquisition

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intracranial Hemorrhage; Intracranial hemorrhage categories may include subdural hematomas, subarachnoid hemorrhages, or intraparenchymal hemorrhages.	Device: 3D Transcranial Ultrasound Brain Imaging; The system implements a proprietary transcranial imaging methodology, which measures the profile of the skull bone and the speed of sound in it to accurately focus the ultrasound energy from a phased array probe through the bone in order to detect hematoma boundaries with resolution normally obtainable only through the open skull.
Epidural Hematoma; Epidural hematoma group will be additionally tested to explore feasibility of scanning to this higher-acuity injury type	Device: 3D Transcranial Ultrasound Brain Imaging; The system implements a proprietary transcranial imaging methodology, which measures the profile of the skull bone and the speed of sound in it to accurately focus the ultrasound energy from a phased array probe through the bone in order to detect hematoma boundaries with resolution normally obtainable only through the open skull.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Intracranial Hemorrhage Detection	The primary outcome is the assessment of the feasibility of 3D-TRUBI for the detection of ICH and other traumatic brain lesions as compared to admission head CT. This is a binary parameter for each type of lesion per patient.	From enrollment to the end of data analysis (18 months)
Evaluation of potential adverse effects	Participants will be evaluated for any potential adverse reactions to performance of the TRUBI exam during and after the research procedure. Twenty-four and 48-hour examination of the head are also planned to record potential adverse reactions.	up to 48 hours after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphometric comparison of 3D-TRUBI with Standard Radiology	If the ICH lesion is detectable on CT, the conventional morphometric analysis of the lesion (maximum thickness, width, and length) and midline shift will be compared with morphometric analysis of the same lesions on 3D-TRUBI images. Measurements of ICH lesions by both modalities will be done in mm (millimeters), so there will be direct numerical comparisons of results using descriptive statistics, and other types of correlation and regression analyses.	From enrollment to end of data analysis (18 months)
Feasibility of 3D-TRUBI Assessment for Detection of Intracranial Hemorrhage	To address feasibility of deployment of the 3D-TRUBI for ICH detection in the acute care setting, we will collect and analyze the time required to recruit, enroll, initiate, complete, and (where appropriate) repeat the assessment for ICH detection.	From enrollment to discharge of subject (7 days)

Collaborators and Investigators

• Sponsor: The Geneva Foundation
• Collaborators: Uniformed Services University of the Health Sciences; Brooke Army Medical Center

Publications and helpful links

General Publications

• E.R.Gr. Maev, K. Shapoori, E.V. Malyarenko, "An Ultrasonic Adaptive Beamforming Method and its Application for Transcranial Imaging", EP 3, 215, 868 B1, October 3, 2018
• D.R.Gr. Maev, K. Shapoori, E.V. Malyarenko, "An ultrasonic adaptive beamforming method and its application for transcranial imaging", US20160187473A1, June 25, 2019
• C.J. Sadler, R.Gr. Maev, E. Malyarenko, "A System to Obtain 3D Images of a Flowing Region Beneath an object using Speckle Reflections", US 9, 842, 384, December 12, 2017
• B.J. Sadler, R.Gr. Maev, E. Malyarenko, "A Method to Obtain 3D Images of a Flowing Region Beneath an object using Speckle Reflections", US 9, 613, 401, April 4, 2017
• Wydra A, Malyarenko E, Shapoori K, Maev RG. Development of a practical ultrasonic approach for simultaneous measurement of the thickness and the sound speed in human skull bones: a laboratory phantom study. Phys Med Biol. 2013 Feb 21;58(4):1083-102. doi: 10.1088/0031-9155/58/4/1083. Epub 2013 Jan 31.

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: ultrasound; traumatic brain injury; intracranial hemorrhage; transcranial ultrasound
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhage, Traumatic; Brain Injuries, Traumatic; Brain Injuries; Hemorrhage; Intracranial Hemorrhages; Brain Hemorrhage, Traumatic
• Other Study ID Numbers: C.2025.005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To minimize risk of breaching confidentiality, individual data will not be shared with other researchers. Aggregate data may be shared upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes