Clinical Utility Study of a Low-Cost Hand-Held Breast Scanner

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

516 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-12-01

Brief Summary

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The primary purpose of this study is to measure the clinical utility (accuracy) of the hand-held breast scanner (iBE) for the detection of breast lesions or lumps. The iBE results will be compared to the results of a current mammogram and/or ultrasound. The duration of study participation is approximately 30 minutes one day.

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Detailed Description

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The FDA approved class II device in this clinical trial is a low-cost hand-held breast scanner (intelligent Breast Exam, iBE). This device is to be used a pre-screening tool for mammograms or ultrasounds. Determination of the accuracy of iBE for the detection of clinically relevant breast lesions will be performed by means of a prospective study.

The iBE evaluation will be performed by a trained licensed practical nurse or ultrasound technologist who is blinded to the outcome of the radiology studies at the time the iBE is performed. The iBE training will be done by the leading iBE user in the United States. The iBE evaluation will be done prior to the patient's original scheduled imaging visit. After the completion of the imaging visit the radiologist will evaluate the mammogram and/or ultrasound images along with the iBE report.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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intelligent Breast Exam, iBE

Single Arm: Additional breast exam by a FDA approved hand-held intelligent breast exam device and a clinical breast exam during their scheduled breast screening appointment. No return visit required for participation.

Group Type OTHER

intelligent Breast Exam, iBE

Intervention Type DEVICE

A bilateral iBE exam will be performed on the entire breast in addition to a clinical breast exam administered by a trained individual. If the patient is selected to participate in the inter-rater reliability portion of the study, the subject will undergo both the iBE and the clinical breast exams twice sequentially performed by two different separately trained individuals during the same visit.

Interventions

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intelligent Breast Exam, iBE

A bilateral iBE exam will be performed on the entire breast in addition to a clinical breast exam administered by a trained individual. If the patient is selected to participate in the inter-rater reliability portion of the study, the subject will undergo both the iBE and the clinical breast exams twice sequentially performed by two different separately trained individuals during the same visit.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years of age and older
* Women and men with symptomatic breast lump (either by palpation or imaging) OR
* Asymptomatic women presenting to the imaging center for a screening mammogram
* Signed Informed Consent

Exclusion Criteria

* Patients under 18 years of age
* Patients who previously participated in this study and are returning to the Women's Imaging Center for follow-up diagnostic tests

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No