Trial Outcomes & Findings for Clinical Utility Study of a Low-Cost Hand-Held Breast Scanner (NCT NCT02597452)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

516 participants

Primary outcome timeframe

approximately one month after imaging scan

Results posted on

2020-04-06

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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 Study STARTED	516
Overall Study COMPLETED	486
Overall Study NOT COMPLETED	30

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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 Study testing incomplete	30

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intelligent Breast Exam, iBE n=486 Participants 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.
Age, Continuous	58 years n=99 Participants
Sex: Female, Male Female	486 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	468 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=99 Participants
Race (NIH/OMB) Asian	9 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=99 Participants
Race (NIH/OMB) Black or African American	153 Participants n=99 Participants
Race (NIH/OMB) White	312 Participants n=99 Participants
Race (NIH/OMB) More than one race	2 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=99 Participants
Region of Enrollment United States	486 Participants n=99 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Intelligent Breast Exam, iBE n=486 Participants 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.
Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results	34.3 percentage of true positive lesions

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Intelligent Breast Exam, iBE n=486 Participants 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.
Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results	80.3 percentage of true negative lesions

SECONDARY outcome

Timeframe: approximately one month after imaging

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

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.

Outcome measures

Outcome measures
Measure	Intelligent Breast Exam, iBE n=4 lesions 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.
Position of the Breast Lesion as Measured by iBE and Mammography	4 lesions

SECONDARY outcome

Timeframe: approximately one month after imaging

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: through study completion an average of 18 months

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: through study completion an average of 18 months

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: through study completion an average of 18 months

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

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

Outcome measures

Outcome measures
Measure	Intelligent Breast Exam, iBE n=486 Participants 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.
Post-stratification of the Analysis of the Reliability by Breast Imaging Reporting and Data System Level iBE true positive findings	12 Participants
Post-stratification of the Analysis of the Reliability by Breast Imaging Reporting and Data System Level iBE true negative findings	362 Participants
Post-stratification of the Analysis of the Reliability by Breast Imaging Reporting and Data System Level iBE false positive findings	89 Participants
Post-stratification of the Analysis of the Reliability by Breast Imaging Reporting and Data System Level iBE flase negative findings	23 Participants

Adverse Events

Intelligent Breast Exam, iBE

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ari D Brooks

Penn Medicine

Phone: 215-829-8461

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place