Performance Assessment of a First Generation Breast Microwave Imaging System: Study of Breast Abnormalities Detection

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Diseases
• Intervention / Treatment: Device: Breast Microwave Imaging

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:

1. 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.
2. 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.
3. 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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• The volunteers should not have breast implants.
• The volunteers should have not yet had a biopsy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Abnormal x-ray Mammography group; 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).	Device: Breast Microwave Imaging; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	1 year

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Stephen Pistorius, Ph.D., University of Manitoba

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2018
• Primary Completion (ANTICIPATED): July 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: July 13, 2015
• First Submitted That Met QC Criteria: October 1, 2015
• First Posted (ESTIMATE): October 2, 2015

Study Record Updates

• Last Update Posted (ACTUAL): May 28, 2019
• Last Update Submitted That Met QC Criteria: May 23, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Medical imaging; Microwaves
• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases
• Other Study ID Numbers: B2015:73

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