Breast DiseasesNCT02566499
Performance Assessment of a First Generation Breast Microwave Imaging System: Study of Breast Abnormalities Detection
A study testing Breast Microwave Imaging in people with Breast Diseases, run by University of Manitoba.
Trial summary
The main goal of this project is to assess the ability of a recently developed Breast Microwave Imaging (BMI) system to detect abnormalities in a human breast. These trials will be performed by recruiting fourteen volunteers that have been diagnosed with breast abnormalities using x-ray mammography. Read more about this study
- Who is it for?
- Ages 40 to 85 years, women only
- Conditions the study is for
- Breast Diseases
- What is being tested?
- Breast Microwave Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2018to Dec 2019
- 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 40 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The volunteers must be at least 40 years old.
- The volunteers should have been diagnosed with a breast abnormality using x-ray mammography within the preceding two months.
Who cannot join
- The volunteers should not have breast implants.
- The volunteers should have not yet had a biopsy.
About this study
The main goal of this project is to assess the ability of a recently developed Breast Microwave Imaging (BMI) system to detect abnormalities in a human breast. These trials will be performed by recruiting fourteen volunteers that have been diagnosed with breast abnormalities using x-ray mammography. The breast presenting the abnormality will be imaged using the BMI system in a controlled and comfortable environment. As this is a feasibility study of the technology, and has the main goal to evaluate the diagnostic accuracy of this technology. The data collected from this study will be used to: (1) evaluate the overall participant experience during the BMI imaging procedure, (2) optimize the design of the BMI imaging system (both hardware and software), (3) open discussions with other medical professionals (e.g. radiologists) about the clinical feasibility of this emerging diagnostic imaging modality.
Read the detailed description
The Breast Microwave Imaging (BMI) system that will be used in this study is designed to detect breast abnormalities using low power microwave waveforms. The system is formed by three main components:
- Patient bed. The volunteer will be positioned in this bed in a prone position where with the breast to be imaged in a pendant position.
- Instrumentation rack. This component contains all the microwave instrumentation and motion mechanisms required to illuminate the breast using an ultrawide band waveform and record the responses from the breast structures.
- Control computer. This component is used to control the motion of the mechanical components of the system and to retrieve the responses from the breast structures from the microwave instruments and store them in an electronic format.
The system takes between 7.5 to 10 minutes to collect a three dimensional dataset from a single breast.
The BMI system used in the study operates in the frequency range of 20 megahertz (MHz) to 9 gigahertz (GHz). Canadian safety limits for the interaction of these non-ionizing electromagnetic waves with humans are outlined in the Health Canada publication "Safety Code 6: Limits of Human Exposure to Radiofrequency Electromagnetic Energy in the Frequency Range from 3 kilohertz (kHz) to 300 GHz [1]. For unregulated environments, the Specific Absorption Rate (SAR) limit set by Health Canada is 1.6 W/Kg. In the system used in this study, radio-frequency energy is generated via the Vector Network Analyzer (VNA). If the VNA is set at its maximum output power, which is 3.2 milliwatt (mW), the power received at 5 cm from the antenna (which is the distance where the breast will be) was measured to be 890 microwatt, which would yield a SAR value of 0.0196 W/kg.
References
[1] Consumer and Clinical Radiation Protection Bureau, Limits of Human Exposure to Radiofrequency Electromagnetic Energy in the Frequency Range from 3 kHz to 300 GHz, Health Canada, Ottawa, Ontario, 2015.
- Conditions
- Breast Diseases
- Being tested
- Breast Microwave Imaging
- Keywords
- Medical imaging, Microwaves
- Medical subject headings
- Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Microwave ImagingDevice
A Breast Microwave Imaging Procedure will be carried out on volunteers who have abnormal x-ray mammograms, prior to the volunteer undergoing a biopsy to confirm diagnosis (as part of their normal care).
| Study group | Role | What they receive |
|---|---|---|
| Abnormal x-ray Mammography group | Experimental | A Breast Microwave Imaging Procedure will be carried out on volunteers who have abnormal x-ray mammograms, prior to the volunteer undergoing a biopsy to confirm diagnosis (as part of their normal care). Receives: Device: Breast Microwave Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy (NO units)
Diagnostic Accuracy = (TP+TN)/(TP+FP+FN+TN): The fraction of patients that are diagnosed accurately, which is in turn a function of the Sensitivity and Specificity of the test.
Sensitivity: The probability that a test result will be positive when the disease is present (true-positive fraction) = TP/(TP+FN)
Specificity: The probability that a test result will be normal when the disease is absent (true-negative fraction) = TN/(FP+TN)
TP = True Positive TN = True Negative FP = False Positive FN = False Negative
Measured: 1 year
Secondary outcomes (2)
Sensitivity (NO units)
Sensitivity: The probability that a test result will be positive when the disease is present (true-positive fraction) = TP/(TP+FN)
TP = True Positive TN = True Negative FP = False Positive FN = False Negative
Measured: 1 year
Specificity (NO units)
Specificity: The probability that a test result will be normal when the disease is absent (true-negative fraction) = TN/(FP+TN)
TP = True Positive TN = True Negative FP = False Positive FN = False Negative
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startJul 2018 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: Improved algorithms have resulted in a proposed redesign of detection system. Once completed, a new trial will be planned.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast DiseasesStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Pistorius, Ph.D., Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566499
- Sponsor's protocol ID
- B2015:73
- Status last verified
- May 2019
- First submitted
- 13 Jul 2015
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Assessment of a First Generation Breast Microwave Imaging System: Study of Breast Abnormalities Detection
- ClinicalTrials.gov ID
- NCT02566499
- Acronym / sponsor ID
- B2015:73
- Conditions
- Breast Diseases
- Keywords
- Medical imaging, Microwaves
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Improved algorithms have resulted in a proposed redesign of detection system. Once completed, a new trial will be planned.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 2 Oct 2015 (estimated)
- 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.
The main goal of this project is to assess the ability of a recently developed Breast Microwave Imaging (BMI) system to detect abnormalities in a human breast. These trials will be performed by recruiting fourteen volunteers that have been diagnosed with breast abnormalities using x-ray mammography. The breast presenting the abnormality will be imaged using the BMI system in a controlled and comfortable environment. As this is a feasibility study of the technology, and has the main goal to evaluate the diagnostic accuracy of this technology. The data collected from this study will be used to: (1) evaluate the overall participant experience during the BMI imaging procedure, (2) optimize the design of the BMI imaging system (both hardware and software), (3) open discussions with other medical professionals (e.g. radiologists) about the clinical feasibility of this emerging diagnostic imaging modality.
Detailed description
The Breast Microwave Imaging (BMI) system that will be used in this study is designed to detect breast abnormalities using low power microwave waveforms. The system is formed by three main components:
- Patient bed. The volunteer will be positioned in this bed in a prone position where with the breast to be imaged in a pendant position.
- Instrumentation rack. This component contains all the microwave instrumentation and motion mechanisms required to illuminate the breast using an ultrawide band waveform and record the responses from the breast structures.
- Control computer. This component is used to control the motion of the mechanical components of the system and to retrieve the responses from the breast structures from the microwave instruments and store them in an electronic format.
The system takes between 7.5 to 10 minutes to collect a three dimensional dataset from a single breast.
The BMI system used in the study operates in the frequency range of 20 megahertz (MHz) to 9 gigahertz (GHz). Canadian safety limits for the interaction of these non-ionizing electromagnetic waves with humans are outlined in the Health Canada publication "Safety Code 6: Limits of Human Exposure to Radiofrequency Electromagnetic Energy in the Frequency Range from 3 kilohertz (kHz) to 300 GHz [1]. For unregulated environments, the Specific Absorption Rate (SAR) limit set by Health Canada is 1.6 W/Kg. In the system used in this study, radio-frequency energy is generated via the Vector Network Analyzer (VNA). If the VNA is set at its maximum output power, which is 3.2 milliwatt (mW), the power received at 5 cm from the antenna (which is the distance where the breast will be) was measured to be 890 microwatt, which would yield a SAR value of 0.0196 W/kg.
References
[1] Consumer and Clinical Radiation Protection Bureau, Limits of Human Exposure to Radiofrequency Electromagnetic Energy in the Frequency Range from 3 kHz to 300 GHz, Health Canada, Ottawa, Ontario, 2015.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abnormal x-ray Mammography group | Experimental | Device: Breast Microwave ImagingA Breast Microwave Imaging Procedure will be carried out on volunteers who have abnormal x-ray mammograms, prior to the volunteer undergoing a biopsy to confirm diagnosis (as part of their normal care). |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The volunteers must be at least 40 years old.
- The volunteers should have been diagnosed with a breast abnormality using x-ray mammography within the preceding two months.
Key exclusion criteria (2 listed)
- The volunteers should not have breast implants.
- The volunteers should have not yet had a biopsy.
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 |
|---|---|---|
| Breast Microwave ImagingA Breast Microwave Imaging Procedure will be carried out on volunteers who have abnormal x-ray mammograms, prior to the volunteer undergoing a biopsy to confirm diagnosis (as part of their normal care). | Device | Abnormal x-ray Mammography group |
Primary outcome
Diagnostic Accuracy (NO units)
Time frame: 1 year
Diagnostic Accuracy = (TP+TN)/(TP+FP+FN+TN): The fraction of patients that are diagnosed accurately, which is in turn a function of the Sensitivity and Specificity of the test. Sensitivity: The probability that a test result will be positive when the disease is present (true-positive fraction) = TP/(TP+FN) Specificity: The probability that a test result will be normal when the disease is absent (true-negative fraction) = TN/(FP+TN) TP = True Positive TN = True Negative FP = False Positive FN = False Negative
2 secondary outcomes
Sensitivity (NO units)
Time frame: 1 year
Specificity (NO units)
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- 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.
Stephen Pistorius, Ph.D. principal investigator
University of Manitoba
Questions about this trial
What is this clinical trial studying?
A study testing Breast Microwave Imaging in people with Breast Diseases, run by University of Manitoba.
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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy (NO units) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2019.