Clinical trial NCT02814292: A Cost-Effective Handheld Breast Scanner for Use in Low Resource Environments: A Validation Study
Official title: A Cost-Effective Handheld Breast Scanner for Use in Low Resource Environments: A Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: UE LifeSciences Inc.
First posted: 2016-06-27
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

18 years or older

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

Exclusion Criteria:

* under 18 years of age

Primary outcomes:
measure: Estimate the sensitivity of the iBE device examinations using imaging results
timeFrame: through study completion an average of 12 months
measure: Estimate the specificity of the iBE device using imaging results
timeFrame: through study completion an average of 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
Study officials:
References:
citation: Broach RB, Geha R, Englander BS, DeLaCruz L, Thrash H, Brooks AD. A cost-effective handheld breast scanner for use in low-resource environments: a validation study. World J Surg Oncol. 2016 Oct 28;14(1):277. doi: 10.1186/s12957-016-1022-2.