Brain Injuries, TraumaticMBI01NCT04666766
Detecting Traumatic Intracranial Hemorrhage With Microwaves and Biomarkers
A study testing Microwave scanning of the head in people with Brain Injuries, Traumatic and Biomarkers, run by Region Skane at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries, Traumatic, Biomarkers, Microwave Imaging
- What is being tested?
- Microwave scanning of the head
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2021to 12 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- Patient is deemed clinically stable
- Patient is ≥ 18 years of age
- Signed informed consent
Who cannot join
- 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
Show all 9Show fewer
- 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
- Previous stroke or other diagnosed and/or treated brain injury
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Helsingborg General Hospital
Helsingborg, Skåne County, 25252
Jakob Lundager Forberg, MD, PhD, 0424061000
Jakob Lundager Forberg, MD, PhD
About this study
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
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.
Read the 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.
- Conditions
- Brain Injuries, Traumatic, Biomarkers, Microwave Imaging
- Being tested
- Microwave scanning of the head
- Keywords
- Microwave Imaging
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave scanning of the headDevice
Also called Assay of 9 different brain biomarkers
A scan of the head will be performed with a microwave device to ascertain the likelihood of intracranial hemorrhage.
| Study group | Role | What they receive |
|---|---|---|
| Traumatic intracranial hemorrhage | Active comparator | Patients with traumatic intracranial hemorrhage diagnosed by Computerized Tomography of the head Receives: Device: Microwave scanning of the head |
| Trauma without traumatic intracranial hemorrhage | Active comparator | Patients with trauma to the head but traumatic intracranial hemorrhage ruled out by Computerized tomography of the head Receives: Device: Microwave scanning of the head |
| Healthy age-matched volunteers | Active comparator | Healthy age-matched volunteers with no previous trauma to the head within the past two weeks. Receives: Device: Microwave scanning of the head |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3.5 years
Secondary outcomes (3)
Estimating anatomic position of intracranial hemorrhage
The accuracy for estimating the position of intracranial hemorrhage with microwave data.
Measured: 3.5 years
Estimating volume of intracranial hemorrhage
The accuracy for estimating the volume of intracranial hemorrhage with microwave data.
Measured: 3.5 years
Adverse events of microwave scan
Any adverse events occurring within 24 hours of microwave scan
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start1 Sep 2021
- Primary completion10 Jan 2025 (estimated)
- Study completion12 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Medfield Diagnostics
- Responsible party
- Sponsor
- Investigators
- Tomas J Vedin, MD, PhD, Principal investigator, Region Skåne and Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666766
- Sponsor's protocol ID
- MBI01
- Acronym
- MBI01
- Status last verified
- Jan 2023
- First submitted
- 13 Nov 2020
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33944977
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04666766
- Acronym / sponsor ID
- MBI01 / MBI01
- Conditions
- Brain Injuries, Traumatic, Biomarkers, Microwave Imaging
- Keywords
- Microwave Imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Medfield Diagnostics
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 10 Jan 2025 (estimated)
- Study completion
- 12 Jan 2026 (estimated)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traumatic intracranial hemorrhage | Active comparator | Device: Microwave scanning of the headPatients with traumatic intracranial hemorrhage diagnosed by Computerized Tomography of the head |
| Trauma without traumatic intracranial hemorrhage | Active comparator | Device: Microwave scanning of the headPatients with trauma to the head but traumatic intracranial hemorrhage ruled out by Computerized tomography of the head |
| Healthy age-matched volunteers | Active comparator | Device: Microwave scanning of the headHealthy age-matched volunteers with no previous trauma to the head within the past two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microwave scanning of the headAlso: Assay of 9 different brain biomarkersA scan of the head will be performed with a microwave device to ascertain the likelihood of intracranial hemorrhage. | Device | Healthy age-matched volunteers, Trauma without traumatic intracranial hemorrhage, Traumatic intracranial hemorrhage |
Primary outcome
Ability to detect intracranial hemorrhage
Time frame: 3.5 years
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 secondary outcomes
Estimating anatomic position of intracranial hemorrhage
Time frame: 3.5 years
Estimating volume of intracranial hemorrhage
Time frame: 3.5 years
Adverse events of microwave scan
Time frame: 3.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Derived from this study: PubMed 33944977Vedin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomas J Vedin, MD, PhD principal investigator
Region Skåne and Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave scanning of the head in people with Brain Injuries, Traumatic and Biomarkers, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tomas J Vedin, MD, PhD (+464263131, tomas.vedin@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to detect intracranial hemorrhage (time frame: 3.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04666766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.