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

Abramson Cancer Center at Penn Medicine

Status: Completed

Conditions: Symptomatic Breast Lump

Treatments: Device: PEFS system (Product Name: Intelligent Breast Exam™ or iBE™

Study type: Interventional

Funder types: Other

Identifiers

NCT02762565

UPCC 24114

Details and patient eligibility

About

Early detection of breast cancer improves the survival rate and makes treatment less costly. This study would measure the accuracy a low-cost hand-held commercially viable device, iBE, for the detection of clinically relevant findings in the breast using the results of current mammography as a comparison. This research will have no impact on clinical decision making.

Enrollment: 89 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

89 participants in 1 patient group

breast scanner

Experimental group

Treatment:

Device: PEFS system (Product Name: Intelligent Breast Exam™ or iBE™