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

NCT02566499 | Withdrawn

• 1 other identifier: B2015:73
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Breast Diseases

Keywords

Medical imaging; Microwaves

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Sensitivity (NO units)

  1 year

• Specificity (NO units)

  1 year

Study Arms (1)

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).

Device: Breast Microwave Imaging

Interventions

Breast Microwave Imaging DEVICE

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).

Abnormal x-ray Mammography group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Manitoba: lead

MeSH Terms

Conditions

Breast Diseases

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Stephen Pistorius, Ph.D.

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: October 2, 2015
• Study Start: July 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 28, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share