A Cost-Effective Handheld Breast Scanner for Use in Low Resource Environments: A Validation Study

June 22, 2016 updated by: University of Pennsylvania
Validation of the PEFS to detect breast tumors will be performed by means of a prospective trial. Subjects will participate for 1 clinic visit. Readings from the PEFS will be studied for reproducibility and predictive ability. Data analysis will be iterative, moving on with each modification of the device until the final prototype is created.

Study Overview

Status

Completed

Conditions

Detailed Description

Phase 2A of this study is directed primarily at prototype development, creating, testing, and modifying a 4x4 finger array device with a small footprint that is battery powered and reliable. The testing in this phase is aimed at proving that modifications did not degrade the screening sensitivity of the original lab prototype.

Target enrollment is up to 100 patients to verify that the investigators have reproducible values in the same patient. Each breast will be evaluated and compared against each other whether it is considered normal or abnormal tissue. Data from patients both normal and abnormal regions will be compared and used to determine predictive value and accuracy in this prototype. The patient population will be women and men 18 years of age or older with symptomatic breast lump either by palpation or imaging.

Symptomatic individuals scheduled to undergo diagnostic exam will be recruited from all patients presenting for breast evaluations at Dr. Brooks clinical practices who meet all the inclusion and exclusion criteria. Consent will be obtained prior to any study related activities. The PEFS evaluation will be performed by a trained individual. Subjects will be scanned in supine position without breast immobilization - similar to ultrasound testing. The PEFS data is recorded and processed by an automated software algorithm and the results are displayed topographically on a breast-map with red areas showing positive findings and black areas showing negative findings. Quantitative data will be documented and analyzed for accuracy metrics. Results will not be given to subjects nor recorded in their medical records. Because this study is not a clinical utility study, results will have no effect on clinical care decisions. The PEFS evaluation may add between 10 and 30 minutes to the clinic visit. No imaging or pathology tests are being done for research purposes.

Study Type

Observational

Enrollment (Actual)

89

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

18 years of age and older Women and men with symptomatic breast lump either by palpation or imaging

Description

Inclusion Criteria:

18 years or older

  • women or men with symptomatic breast lump by palpation or imaging

Exclusion Criteria:

  • under 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Estimate the sensitivity of the iBE device examinations using imaging results
Time Frame: through study completion an average of 12 months
through study completion an average of 12 months
Estimate the specificity of the iBE device using imaging results
Time Frame: through study completion an average of 12 months
through study completion an average of 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

UE LifeSciences Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

June 22, 2016

First Posted (Estimate)

June 27, 2016

Study Record Updates

Last Update Posted (Estimate)

June 27, 2016

Last Update Submitted That Met QC Criteria

June 22, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 819121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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