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NCT Number: NCT02597452

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intelligent Breast Exam, iBE

Device

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.

Primary outcomes

  1. Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results

    Time frame: approximately one month after imaging scan

    comparing the calculated the sensitivities or the percentage of true positive breast lesions (based on imaging results) of the iBE and CBE

  2. Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results

    Time frame: approximately one month after imaging

    comparing the calculated the specificities or the percentage of true negative lesions (based on imaging results) of the iBE and CBE

Secondary outcomes

  1. Position of the Breast Lesion as Measured by iBE and Mammography

    Time frame: approximately one month after imaging

    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.

  2. Size Detection of the Breast Lesions Identified by iBE

    Time frame: approximately one month after imaging

    The size detected of the breast lesion (cm) by mammogram or ultrasound

  3. Inter-rate Reliability of the iBE and the CBE Number of Lesions Detected

    Time frame: through study completion an average of 18 months

    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

  4. Inter-rate Reliability of the iBE and the CBE Position of Lesions Detected

    Time frame: through study completion an average of 18 months

    comparing the position(s) results of two independent healthcare professionals consecutive evaluations of the same patient with the iBE device and clinical breast exam

  5. Post-stratification of the Analysis of the Reliability by Breast Imaging Reporting and Data System Level

    Time frame: through study completion an average of 18 months

    breakdown of the iBE clinically relevant findings and negative findings by the BIRAD levels determination from the gold standard final results

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • UE LifeSciences Inc.

Registry information

Acronym: iBE

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 5, 2015
Registry last updated
Apr 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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