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

Abramson Cancer Center at Penn Medicine logo

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™

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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