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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: intelligent Breast Exam, iBE

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 516
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Pennsylvania Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: intelligent Breast Exam, iBE; 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.

Device: intelligent Breast Exam, iBE; A bilateral iBE exam will be performed on the entire breast in addition to a clinical breast exam administered by a trained individual. If the patient is selected to participate in the inter-rater reliability portion of the study, the subject will undergo both the iBE and the clinical breast exams twice sequentially performed by two different separately trained individuals during the same visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results	comparing the calculated the sensitivities or the percentage of true positive breast lesions (based on imaging results) of the iBE and CBE	approximately one month after imaging scan
Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results	comparing the calculated the specificities or the percentage of true negative lesions (based on imaging results) of the iBE and CBE	approximately one month after imaging

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Position of the Breast Lesion as Measured by iBE and Mammography	agreement of the position of the lesion, defined by time coordinate measured by iBE and mammography or ultrasound that fall within a 3 hour time quadrants on a clock of each other.	approximately one month after imaging
Size Detection of the Breast Lesions Identified by iBE	The size detected of the breast lesion (cm) by mammogram or ultrasound	approximately one month after imaging
Inter-rate Reliability of the iBE and the CBE Number of Lesions Detected	comparing the number of breast lesions detected two independent healthcare professionals consecutive evaluations of the same patient with the iBE device and clinical breast exam	through study completion an average of 18 months
Inter-rate Reliability of the iBE and the CBE Position of Lesions Detected	comparing the position(s) results of two independent healthcare professionals consecutive evaluations of the same patient with the iBE device and clinical breast exam	through study completion an average of 18 months
Post-stratification of the Analysis of the Reliability by Breast Imaging Reporting and Data System Level	breakdown of the iBE clinically relevant findings and negative findings by the BIRAD levels determination from the gold standard final results	through study completion an average of 18 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: UE LifeSciences Inc.
• Investigators: Principal Investigator: Ari D Brooks, MD, University of Pennsylvania

Publications and helpful links

General Publications

• Clanahan JM, Reddy S, Broach RB, Rositch AF, Anderson BO, Wileyto EP, Englander BS, Brooks AD. Clinical Utility of a Hand-Held Scanner for Breast Cancer Early Detection and Patient Triage. JCO Glob Oncol. 2020 Feb;6:27-34. doi: 10.1200/JGO.19.00205.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: October 23, 2015
• First Submitted That Met QC Criteria: November 3, 2015
• First Posted (Estimate): November 5, 2015

Study Record Updates

• Last Update Posted (Actual): April 6, 2020
• Last Update Submitted That Met QC Criteria: April 3, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: breast cancer screening; breast lump; breast exam; breast lump detection
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 821412-UPCC24114