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

Not Applicable

Completed

• Conditions: Symptomatic Breast Lump

• Registration Number: NCT02762565
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2016-01
• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2016-05-04
• Study First Posted: 2016-05-05
• Study Completion: 2016-12
• Results First Submitted: 2021-04-05
• Results First Submitted QC: 2021-04-05
• Results First Posted: 2021-04-29
• Status Verified: 2021-05
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Quadrants With Detected Breast Lesions	3 months	The iBE results were evaluated by definitive quadrants. The definitive quadrants break down the superimposed clock into 4 equal sectors (e.g. 12-3, 3-6, 6-9, 9-12).
Sensitivity of iBE Breast Lesion Detection	1 day	the number of quadrants with positive breast lesion detected by iBE confirmed by mammogram and ultrasound, 4 quadrants per breast per participant. 77 quadrants were labeled positive for breast lesion by iBE, 66 were confirmed positive by mammogram or ultrasound allowing calculation of sensitivity of the the iBE breast lesion detection
Specificity of iBE Breast Lesion Detection	1 day	the number of quadrants characterized normal breast by iBE confirmed by mammogram and ultrasound, 4 quadrants per breast per participant

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States