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

NCT02597452 | Completed Results

• 1 other identifier: 821412-UPCC24114
• Study Type: interventional
• Target: 516
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

breast lump; breast exam; breast cancer screening; breast lump detection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Position of the Breast Lesion as Measured by iBE and Mammography

  approximately one month after imaging

• Size Detection of the Breast Lesions Identified by iBE

  approximately one month after imaging

• Inter-rate Reliability of the iBE and the CBE Number of Lesions Detected

  through study completion an average of 18 months

• Inter-rate Reliability of the iBE and the CBE Position of Lesions Detected

  through study completion an average of 18 months

• Post-stratification of the Analysis of the Reliability by Breast Imaging Reporting and Data System Level

  through study completion an average of 18 months

Study Arms (1)

intelligent Breast Exam, iBE

OTHER

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

Interventions

intelligent Breast Exam, iBE DEVICE

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.

intelligent Breast Exam, iBE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• UE LifeSciences Inc.: collaborator

Study Sites (1)

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• 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.

  PMID: 32031433 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

* difficulty recruiting patients with positive mammograms as this was unknown at time of enrollment * difficulty recruiting patients for dual study for the inter-reliability study due to the increase in their scheduled visit time.

Results Point of Contact

• Title: Dr. Ari D Brooks
• Organization: Penn Medicine

ari.brooks@pennmedicine.upenn.edu

215-829-8461

Study Officials

• Ari D Brooks, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: November 5, 2015
• Study Start: March 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 6, 2020
• Results First Posted: April 6, 2020

Record last verified: 2020-04

Locations

US (1)