Clinical trial NCT06780436: 3D Transcranial Ultrasound Brain Imaging (3D-TRUBI) Instrument for Point-of-Care Diagnosis of Intracranial Hemorrhages
Official title: 3D Transcranial Ultrasound Brain Imaging (3D-TRUBI) Instrument for Point-of-Care Diagnosis of Intracranial Hemorrhages Caused by Traumatic Brain Injuries
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Traumatic Brain Hemorrhage
Traumatic Brain Injury
Intracranial Hemorrhages
Ultrasound Exams
3D SONOGRAPHY
Keywords: transcranial ultrasound
traumatic brain injury
intracranial hemorrhage
ultrasound
Lead sponsor: The Geneva Foundation
Sponsor class: OTHER
Collaborators: name: Brooke Army Medical Center
name: Uniformed Services University of the Health Sciences
First posted: 2025-01-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from qualifying Traumatic Brain Injuries accepted for care at Brooke Army Medical Center

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Intracranial Hemorrhage Detection
timeFrame: From enrollment to the end of data analysis (18 months)
measure: Evaluation of potential adverse effects
timeFrame: up to 48 hours after enrollment
Secondary outcomes:
measure: Morphometric comparison of 3D-TRUBI with Standard Radiology
timeFrame: From enrollment to end of data analysis (18 months)
measure: Feasibility of 3D-TRUBI Assessment for Detection of Intracranial Hemorrhage
timeFrame: From enrollment to discharge of subject (7 days)
Other outcomes:
Locations:
city: Ft. Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
References:
citation: 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
citation: D.R.Gr. Maev, K. Shapoori, E.V. Malyarenko, "An ultrasonic adaptive beamforming method and its application for transcranial imaging", US20160187473A1, June 25, 2019
citation: 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
citation: 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
citation: 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.