Trial Outcomes & Findings for Clinical Utility of a Low-Cost Hand-Held Breast Scanner (NCT NCT02762565)

NCT ID: NCT02762565

Last Updated: 2021-08-16

Results Overview

The iBE results were evaluated by definitive quadrants. The definitive quadrants break down the superimposed clock into 4 equal sectors (e.g. 12-3, 3-6, 6-9, 9-12).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 89 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2021-08-16

Participant Flow

Participant milestones

Measure	Breast Scanner One time use of PEFS system (Product Name: Intelligent Breast Exam™ or iBE™) on breast
Overall Study STARTED	89
Overall Study COMPLETED	78
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Measure	Breast Scanner One time use of PEFS system (Product Name: Intelligent Breast Exam™ or iBE™) on breast
Overall Study Missing iBE data: a result of incomplete data transfer from the iBE	11

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Breast Scanner n=78 Participants PEFS system (Product Name: Intelligent Breast Exam™ or iBE™
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	71 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	42 years n=5 Participants
Sex: Female, Male Female	77 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	69 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	27 Participants n=5 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Region of Enrollment United States	78 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: the iBE result of each participant was broken into 4 quadrants for each breast. Some quadrants were missing iBE data. 78 participants and 342 quadrants, 77 is the number of quadrants with positive findings of the 78 participants and the 342 quadrants analyzed.

The iBE results were evaluated by definitive quadrants. The definitive quadrants break down the superimposed clock into 4 equal sectors (e.g. 12-3, 3-6, 6-9, 9-12).

Outcome measures

Measure	Breast Scanner n=342 quadrants PEFS system (Product Name: Intelligent Breast Exam™ or iBE™
Number of Quadrants With Detected Breast Lesions Number of quadrants positive for a lesion	77 quadrants
Number of Quadrants With Detected Breast Lesions Number of quadrants negative for a lesion	265 quadrants

PRIMARY outcome

Timeframe: 1 day

Population: quadrants with positive breast lesions

the number of quadrants with positive breast lesion detected by iBE confirmed by mammogram and ultrasound, 4 quadrants per breast per participant. 77 quadrants were labeled positive for breast lesion by iBE, 66 were confirmed positive by mammogram or ultrasound allowing calculation of sensitivity of the the iBE breast lesion detection

Outcome measures

Measure	Breast Scanner n=77 quadrants PEFS system (Product Name: Intelligent Breast Exam™ or iBE™
Sensitivity of iBE Breast Lesion Detection	66 quadrants

PRIMARY outcome

Timeframe: 1 day

Population: breast quadrants negative for breast lesions

the number of quadrants characterized normal breast by iBE confirmed by mammogram and ultrasound, 4 quadrants per breast per participant

Outcome measures

Measure	Breast Scanner n=265 quadrants PEFS system (Product Name: Intelligent Breast Exam™ or iBE™
Specificity of iBE Breast Lesion Detection	237 quadrants

Adverse Events

Breast Scanner

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

Robyn Broach

University of Pennsylvnia

Phone: 215-662-7300

Email: robyn.broach@uphs.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place