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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02814292
• Other study ID #: 819121
• Status: Completed
• Phase: N/A
• First received: June 14, 2016
• Last updated: June 22, 2016
• Start date: June 2014
• Est. completion date: February 2015

Study information

• Verified date: June 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	UE LifeSciences Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate the sensitivity of the iBE device examinations using imaging results		through study completion an average of 12 months	No
Primary	Estimate the specificity of the iBE device using imaging results		through study completion an average of 12 months	No