Detecting Traumatic Intracranial Hemorrhage With Microwaves and Biomarkers (MBI01)

Detecting Traumatic Intracranial Hemorrhage With Microwaves and Biomarkers: A Prospective Study Evaluating Ability of Microwave Scanning in Conjunction With Biomarkers to Diagnose Traumatic Intracranial Hemorrhage

This study will evaluate if traumatic intracranial hemorrhage can be safely ruled out by using a microwave scanner (MD100) in conjunction with a combination of different brain biomarkers analyzed in serum.

Study Overview

• Status: Recruiting
• Conditions: Brain Injuries, Traumatic; Biomarkers; Microwave Imaging
• Intervention / Treatment: Device: Microwave scanning of the head

Detailed Description

This is a prospective, open, multicentre trial that will enrol patients presenting to the Emergency Department (ED) because of isolated head trauma or head trauma as part of a multi trauma. Microwave scanning characteristics and biomarkers in patients with traumatic intracranial haemorrhage (TICH) (Group A) will be compared to patients with head trauma that do not have TICH (Group B). All adult patients with trauma to the head will be eligible for inclusion if a medical professional has evaluated the risk of spine injury. After additional physical examination, control of inclusion- and exclusion criteria and after informed consent has been acquired, the microwave measurement and blood sampling will be performed. Before enrolment in the study, and in the acute phase, one of the investigators or a member of the investigator staff must explain verbally the implications of study participation to the patient, and the patient is asked to give a verbal consent. As soon as is practically possible after the acute phase of the disease, the patient will sign and personally date the informed consent form. In cases where the patient is not capable to read and/or sign the informed consent, due to disability, an independent witness shall be present throughout the process of reading the written informed consent and any other information aloud and explained to the prospective patient. As an independent witness, healthcare professionals who are not responsible or in any way involved in the patient's care or treatment are accepted. The independent witness can sign on the behalf of the patient in the presence of the patient and the Investigator. More details of the informed consent procedure are described in this Clinical Investigation Plan, section 6.3.

The microwave measurement will take less than five minutes (the duration of the actual measurement is about 1,5 min and will not interfere with the patient's standard of care). The Research Nurse or the Investigator documents all patient clinical trial information in the eCRF.

Safety and usability will be evaluated throughout the trial, and a safety follow-up will be performed by the Research Nurse or Investigator approximately 24 hours after the measurement procedure.

During the data processing phase of study, the result of the microwave measurement will be compared to the result of the biomarkers, CT examination and the patient's final diagnosis. As a control group, approximately 50 demographically matched healthy volunteers (Group C) will be asked to participate in the trial. The trial will provide knowledge of the predictive value of microwave measurement and biomarkers for the diagnosis of intracranial haemorrhages in the acute TBI phase.

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tomas J Vedin, MD, PhD; Phone Number: +464263131; Email: tomas.vedin@med.lu.se
• Study Contact Backup: Name: Jacob Lundager Foberg, MD, PhD; Phone Number: +464261000; Email: jakob.lundager-forberg@med.lu.se

Study Locations

• Sweden
  • Skåne
    • Helsingborg, Skåne, Sweden, 25252
      • Recruiting
      • Helsingborg General Hospital
      • Contact: Jakob Lundager Forberg, MD, PhD; Phone Number: 0424061000
      • Sub-Investigator: Jakob Lundager Forberg, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria (groups A and B):

• Verbal Informed Consent in the acute phase.
• Signed Informed Consent Form after the acute phase. On behalf of the patient, independent witness signed informed consent (in cases where the patient is unable to sign).
• Acute trauma patient with suspected head injury
• Time from injury to measurement procedure not longer than 8 hours 15 min
• Head CT prescribed by treating physician
• Patient is ≥ 18 years of age
• Patient is deemed clinically stable

Exclusion Criteria (groups A and B):

• Patient has suspected cervical spine fracture, per the Investigator's judgement
• Patient has by CT confirmed cervical spine fracture
• Patient has confirmed skull fracture with risk for dislocation.
• Patient has a shunt or other foreign object implanted intracranially (if known by medical records)
• Patient has agraffes or other metal parts, thick bandage (>1cm), or other foreign materials attached to the head that are deemed to interfere with the diagnostic procedure.
• Patient diagnosed with a condition associated with risk of poor protocol compliance
• The measurement procedure is deemed to interfere with the standard of care
• Other condition or symptoms preventing the patient from entering the trial, per the investigator´s judgment

Inclusion Criteria (Group C):

• Patient is ≥ 18 years of age
• Signed informed consent

Exclusion Criteria (Group C):

• Previous stroke or other diagnosed and/or treated brain injury

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traumatic intracranial hemorrhage; Patients with traumatic intracranial hemorrhage diagnosed by Computerized Tomography of the head	Device: Microwave scanning of the head; A scan of the head will be performed with a microwave device to ascertain the likelihood of intracranial hemorrhage.; Other Names: Assay of 9 different brain biomarkers
Active Comparator: Trauma without traumatic intracranial hemorrhage; Patients with trauma to the head but traumatic intracranial hemorrhage ruled out by Computerized tomography of the head	Device: Microwave scanning of the head; A scan of the head will be performed with a microwave device to ascertain the likelihood of intracranial hemorrhage.; Other Names: Assay of 9 different brain biomarkers
Active Comparator: Healthy age-matched volunteers; Healthy age-matched volunteers with no previous trauma to the head within the past two weeks.	Device: Microwave scanning of the head; A scan of the head will be performed with a microwave device to ascertain the likelihood of intracranial hemorrhage.; Other Names: Assay of 9 different brain biomarkers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability to detect intracranial hemorrhage	The ability of the device MD100, with and without brain biomarkers (Aβ40, Aβ42, GFAP, H-FABP, S100B, NF-L, NSE, UCH-L1 and IL-10) to detect traumatic intracranial haemorrhage, as measured by the area under the receiver operating characteristics curve.	3.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimating anatomic position of intracranial hemorrhage	The accuracy for estimating the position of intracranial hemorrhage with microwave data.	3.5 years
Estimating volume of intracranial hemorrhage	The accuracy for estimating the volume of intracranial hemorrhage with microwave data.	3.5 years
Adverse events of microwave scan	Any adverse events occurring within 24 hours of microwave scan	3.5 years

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Medfield Diagnostics
• Investigators: Principal Investigator: Tomas J Vedin, MD, PhD, Region Skåne and Lund University

Publications and helpful links

General Publications

• Vedin T, Bergenfeldt H, Holmstrom E, Lundager-Forberg J, Edelhamre M. Microwave scan and brain biomarkers to rule out intracranial hemorrhage: study protocol of a planned prospective study (MBI01). Eur J Trauma Emerg Surg. 2022 Apr;48(2):1335-1342. doi: 10.1007/s00068-021-01671-7. Epub 2021 May 4.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): January 10, 2025
• Study Completion (Anticipated): January 12, 2026

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Estimate): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Microwave Imaging
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Hemorrhage; Brain Injuries, Traumatic; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic
• Other Study ID Numbers: MBI01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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