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

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT02597452
• Collaborator: UE LifeSciences Inc. (Industry)
• Enrollment: 516
• Location: 1
• Arm: 1
• Duration (Months): 45
• Patients Per Site Per Month: 11.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Device: intelligent Breast Exam, iBE	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 516 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Clinical Utility Study of a Low-Cost Hand-Held Breast Scanner
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Nov 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm

Intervention/Treatment

Other: intelligent Breast Exam, iBE Single Arm: Additional breast exam by a FDA approved hand-held intelligent breast exam device and a clinical breast exam during their scheduled breast screening appointment. No return visit required for participation.

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• University of Pennsylvania
• UE LifeSciences Inc.

Investigators

• Principal Investigator: Ari D Brooks, MD, University of Pennsylvania

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 9, 2014

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02597452
• Other Study ID Numbers: 821412-UPCC24114
• First Posted: Nov 5, 2015
• Last Update Posted: Apr 6, 2020
• Last Verified: Apr 1, 2020

• Keywords provided by University of Pennsylvania: breast lump; breast exam; breast cancer screening; breast lump detection
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

Participant Flow

Arm/Group Title	Intelligent Breast Exam, iBE
Arm/Group Description	Single Arm: Additional breast exam by a FDA approved hand-held intelligent breast exam device and a clinical breast exam during their scheduled breast screening appointment. No return visit required for participation. 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.
Period Title: Overall Study
STARTED	516
COMPLETED	486
NOT COMPLETED	30

Baseline Characteristics

Arm/Group Title	Intelligent Breast Exam, iBE
Arm/Group Description	Single Arm: Additional breast exam by a FDA approved hand-held intelligent breast exam device and a clinical breast exam during their scheduled breast screening appointment. No return visit required for participation. 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.
Overall Participants	486
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	58
Sex: Female, Male (Count of Participants)
Female	486 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	17 3.5%
Not Hispanic or Latino	468 96.3%
Unknown or Not Reported	1 0.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 0.4%
Asian	9 1.9%
Native Hawaiian or Other Pacific Islander	1 0.2%
Black or African American	153 31.5%
White	312 64.2%
More than one race	2 0.4%
Unknown or Not Reported	7 1.4%
Region of Enrollment (Count of Participants)
United States	486 100%

Outcome Measures

1. Primary Outcome

Title	Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results
Description	comparing the calculated the sensitivities or the percentage of true positive breast lesions (based on imaging results) of the iBE and CBE
Time Frame	approximately one month after imaging scan

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intelligent Breast Exam, iBE
Arm/Group Description	Single Arm: Additional breast exam by a FDA approved hand-held intelligent breast exam device and a clinical breast exam during their scheduled breast screening appointment. No return visit required for participation. 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.
Measure Participants	486
Number [percentage of true positive lesions]	34.3

2. Primary Outcome

Title	Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results
Description	comparing the calculated the specificities or the percentage of true negative lesions (based on imaging results) of the iBE and CBE
Time Frame	approximately one month after imaging

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intelligent Breast Exam, iBE
Arm/Group Description	Single Arm: Additional breast exam by a FDA approved hand-held intelligent breast exam device and a clinical breast exam during their scheduled breast screening appointment. No return visit required for participation. 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.
Measure Participants	486
Number [percentage of true negative lesions]	80.3

3. Secondary Outcome

Title	Position of the Breast Lesion as Measured by iBE and Mammography
Description	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.
Time Frame	approximately one month after imaging

Outcome Measure Data

Analysis Population Description

Number of subjects who had a lesion identified by iBE and mammogram, ultrasound, or MRI.

Arm/Group Title	Intelligent Breast Exam, iBE
Arm/Group Description	Single Arm: Additional breast exam by a FDA approved hand-held intelligent breast exam device and a clinical breast exam during their scheduled breast screening appointment. No return visit required for participation. 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.
Measure Participants	5
Measure lesions	4
Count of Units [lesions]	4

4. Secondary Outcome

Title	Size Detection of the Breast Lesions Identified by iBE
Description	The size detected of the breast lesion (cm) by mammogram or ultrasound
Time Frame	approximately one month after imaging

Outcome Measure Data

Analysis Population Description

The size was not measured by iBE. Only 4 of the 7 lesions were detected by iBE and size data was not available to analyze.

Arm/Group Title	Intelligent Breast Exam, iBE
Arm/Group Description	Single Arm: Additional breast exam by a FDA approved hand-held intelligent breast exam device and a clinical breast exam during their scheduled breast screening appointment. No return visit required for participation. 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.
Measure Participants	0
Measure lesions	0

5. Secondary Outcome

Title	Inter-rate Reliability of the iBE and the CBE Number of Lesions Detected
Description	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
Time Frame	through study completion an average of 18 months

Outcome Measure Data

Analysis Population Description

Difficulty enrolling patients for this outcome as a result of the participants undergoing the iBE and CBE twice by two different healthcare professionals. Subjects declined to continue after first healthcare professional exams was complete. Comparison data between healthcare professionals was not available to analyze.

Arm/Group Title	Intelligent Breast Exam, iBE
Arm/Group Description	Single Arm: Additional breast exam by a FDA approved hand-held intelligent breast exam device and a clinical breast exam during their scheduled breast screening appointment. No return visit required for participation. 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.
Measure Participants	0

6. Secondary Outcome

Title	Inter-rate Reliability of the iBE and the CBE Position of Lesions Detected
Description	comparing the position(s) results of two independent healthcare professionals consecutive evaluations of the same patient with the iBE device and clinical breast exam
Time Frame	through study completion an average of 18 months

Outcome Measure Data

Analysis Population Description

Difficulty enrolling patients for this outcome as a result of the participants undergoing the iBE and CBE twice by two different healthcare professionals. Subjects declined to continue after first healthcare professional exams was complete. Comparison data between healthcare professionals was not available to analyze.

Arm/Group Title	Intelligent Breast Exam, iBE
Arm/Group Description	Single Arm: Additional breast exam by a FDA approved hand-held intelligent breast exam device and a clinical breast exam during their scheduled breast screening appointment. No return visit required for participation. 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.
Measure Participants	0

7. Secondary Outcome

Title	Post-stratification of the Analysis of the Reliability by Breast Imaging Reporting and Data System Level
Description	breakdown of the iBE clinically relevant findings and negative findings by the BIRAD levels determination from the gold standard final results
Time Frame	through study completion an average of 18 months

Outcome Measure Data

Analysis Population Description

The specificity of iBE relevant findings (BIRADs 0, 3-5) vs benign findings (BIRADS 1, 2) from the results of mammography

Arm/Group Title	Intelligent Breast Exam, iBE
Arm/Group Description	Single Arm: Additional breast exam by a FDA approved hand-held intelligent breast exam device and a clinical breast exam during their scheduled breast screening appointment. No return visit required for participation. 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.
Measure Participants	486
iBE true positive findings	12 2.5%
iBE true negative findings	362 74.5%
iBE false positive findings	89 18.3%
iBE flase negative findings	23 4.7%

Adverse Events

Time Frame	All participants were monitored for adverse events during a single visit, up to 1 hour.
Arm/Group Title	Intelligent Breast Exam, iBE
Arm/Group Description	Single Arm: Additional breast exam by a FDA approved hand-held intelligent breast exam device and a clinical breast exam during their scheduled breast screening appointment. No return visit required for participation. 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.
All Cause Mortality
	Intelligent Breast Exam, iBE
	Affected / at Risk (%)	# Events
Total	0/486 (0%)
Serious Adverse Events
	Intelligent Breast Exam, iBE
	Affected / at Risk (%)	# Events
Total	0/486 (0%)
Other (Not Including Serious) Adverse Events
	Intelligent Breast Exam, iBE
	Affected / at Risk (%)	# Events
Total	0/486 (0%)

Limitations/Caveats

difficulty recruiting patients with positive mammograms as this was unknown at time of enrollment difficulty recruiting patients for dual study for the inter-reliability study due to the increase in their scheduled visit time.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.