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

NCT02566499 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-05-28

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Stephen Pistorius, Ph.D. · University of Manitoba

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2019-07-31
Completion
2019-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02566499 on ClinicalTrials.gov