Completed

NCT Number: NCT02762565

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

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.

Completed

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Key information

Conditions

Symptomatic Breast Lump

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Primary outcomes

Number of Quadrants With Detected Breast Lesions

Time frame: 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

Time frame: 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

Time frame: 1 day

the number of quadrants characterized normal breast by iBE confirmed by mammogram and ultrasound, 4 quadrants per breast per participant

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: May 5, 2016
Registry last updated: Aug 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.