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Detecting Traumatic Intracranial Hemorrhage With Microwaves and Biomarkers (MBI01)

Primary Purpose

Brain Injuries, Traumatic, Biomarkers, Microwave Imaging

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Microwave scanning of the head
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Injuries, Traumatic focused on measuring Microwave Imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Helsingborg General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Traumatic intracranial hemorrhage

Trauma without traumatic intracranial hemorrhage

Healthy age-matched volunteers

Arm Description

Patients with traumatic intracranial hemorrhage diagnosed by Computerized Tomography of the head

Patients with trauma to the head but traumatic intracranial hemorrhage ruled out by Computerized tomography of the head

Healthy age-matched volunteers with no previous trauma to the head within the past two weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Estimating anatomic position of intracranial hemorrhage
The accuracy for estimating the position of intracranial hemorrhage with microwave data.
Estimating volume of intracranial hemorrhage
The accuracy for estimating the volume of intracranial hemorrhage with microwave data.
Adverse events of microwave scan
Any adverse events occurring within 24 hours of microwave scan

Full Information

First Posted
November 13, 2020
Last Updated
January 23, 2023
Sponsor
Region Skane
Collaborators
Medfield Diagnostics
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1. Study Identification

Unique Protocol Identification Number
NCT04666766
Brief Title
Detecting Traumatic Intracranial Hemorrhage With Microwaves and Biomarkers
Acronym
MBI01
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
January 10, 2025 (Anticipated)
Study Completion Date
January 12, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
Collaborators
Medfield Diagnostics

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Traumatic, Biomarkers, Microwave Imaging
Keywords
Microwave Imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
No results of the biomarker assays or microwave scans will be visible to the care givers or the participants.
Allocation
Non-Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traumatic intracranial hemorrhage
Arm Type
Active Comparator
Arm Description
Patients with traumatic intracranial hemorrhage diagnosed by Computerized Tomography of the head
Arm Title
Trauma without traumatic intracranial hemorrhage
Arm Type
Active Comparator
Arm Description
Patients with trauma to the head but traumatic intracranial hemorrhage ruled out by Computerized tomography of the head
Arm Title
Healthy age-matched volunteers
Arm Type
Active Comparator
Arm Description
Healthy age-matched volunteers with no previous trauma to the head within the past two weeks.
Intervention Type
Device
Intervention Name(s)
Microwave scanning of the head
Other Intervention Name(s)
Assay of 9 different brain biomarkers
Intervention Description
A scan of the head will be performed with a microwave device to ascertain the likelihood of intracranial hemorrhage.
Primary Outcome Measure Information:
Title
Ability to detect intracranial hemorrhage
Description
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.
Time Frame
3.5 years
Secondary Outcome Measure Information:
Title
Estimating anatomic position of intracranial hemorrhage
Description
The accuracy for estimating the position of intracranial hemorrhage with microwave data.
Time Frame
3.5 years
Title
Estimating volume of intracranial hemorrhage
Description
The accuracy for estimating the volume of intracranial hemorrhage with microwave data.
Time Frame
3.5 years
Title
Adverse events of microwave scan
Description
Any adverse events occurring within 24 hours of microwave scan
Time Frame
3.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tomas J Vedin, MD, PhD
Phone
+464263131
Email
tomas.vedin@med.lu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob Lundager Foberg, MD, PhD
Phone
+464261000
Email
jakob.lundager-forberg@med.lu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomas J Vedin, MD, PhD
Organizational Affiliation
Region Skåne and Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsingborg General Hospital
City
Helsingborg
State/Province
Skåne
ZIP/Postal Code
25252
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jakob Lundager Forberg, MD, PhD
Phone
0424061000
First Name & Middle Initial & Last Name & Degree
Jakob Lundager Forberg, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33944977
Citation
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.
Results Reference
derived

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Detecting Traumatic Intracranial Hemorrhage With Microwaves and Biomarkers

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