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

University of Pennsylvania

Status: Completed

Conditions: Breast Cancer

Treatments: Device: intelligent Breast Exam, iBE

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02597452

821412-UPCC24114

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 516 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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516 participants in 1 patient group

intelligent Breast Exam, iBE

Other group

Description:

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.

Treatment:

Device: intelligent Breast Exam, iBE