Clinical trial NCT02597452: Clinical Utility Study of a Low-Cost Hand-Held Breast Scanner
Official title: Clinical Utility Study of a Low-Cost Hand-Held Breast Scanner
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast lump
breast exam
breast cancer screening
breast lump detection
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: UE LifeSciences Inc.
First posted: 2015-11-05
Enrollment: 516
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results
timeFrame: approximately one month after imaging scan
measure: Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results
timeFrame: approximately one month after imaging
Secondary outcomes:
measure: Position of the Breast Lesion as Measured by iBE and Mammography
timeFrame: approximately one month after imaging
measure: Size Detection of the Breast Lesions Identified by iBE
timeFrame: approximately one month after imaging
measure: Inter-rate Reliability of the iBE and the CBE Number of Lesions Detected
timeFrame: through study completion an average of 18 months
measure: Inter-rate Reliability of the iBE and the CBE Position of Lesions Detected
timeFrame: through study completion an average of 18 months
measure: Post-stratification of the Analysis of the Reliability by Breast Imaging Reporting and Data System Level
timeFrame: through study completion an average of 18 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Ari D Brooks, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.