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

Breast Cancer Clinical Trial

— iBE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02597452
• Other study ID #: 821412-UPCC24114
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: December 1, 2017

Study information

• Verified date: April 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 516
• Est. completion date: December 1, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• intelligent Breast Exam, iBE
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.

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	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
Primary	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	Position of the Breast Lesion as Measured by iBE and Mammography	agreement of the position of the lesion, defined by time coordinate measured by iBE and mammography or ultrasound that fall within a 3 hour time quadrants on a clock of each other.	approximately one month after imaging
Secondary	Size Detection of the Breast Lesions Identified by iBE	The size detected of the breast lesion (cm) by mammogram or ultrasound	approximately one month after imaging
Secondary	Inter-rate Reliability of the iBE and the CBE Number of Lesions Detected	comparing the number of breast lesions detected two independent healthcare professionals consecutive evaluations of the same patient with the iBE device and clinical breast exam	through study completion an average of 18 months
Secondary	Inter-rate Reliability of the iBE and the CBE Position of Lesions Detected	comparing the position(s) results of two independent healthcare professionals consecutive evaluations of the same patient with the iBE device and clinical breast exam	through study completion an average of 18 months
Secondary	Post-stratification of the Analysis of the Reliability by Breast Imaging Reporting and Data System Level	breakdown of the iBE clinically relevant findings and negative findings by the BIRAD levels determination from the gold standard final results	through study completion an average of 18 months