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

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT02762565
• Collaborator: (none)
• Enrollment: 89
• Location: 1
• Arm: 1
• Actual Duration (Months): 22
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

Early detection of breast cancer improves the survival rate and makes treatment less costly. This study would measure the accuracy a low-cost hand-held commercially viable device, iBE, for the detection of clinically relevant findings in the breast using the results of current mammography as a comparison. This research will have no impact on clinical decision making.

Condition or Disease	Intervention/Treatment	Phase
Symptomatic Breast Lump	Device: PEFS system (Product Name: Intelligent Breast Exam™ or iBE™	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 89 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Primary Purpose: Diagnostic
• Official Title: Clinical Utility of a Low-Cost Hand-Held Breast Scanner
• Actual Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: breast scanner	Device: PEFS system (Product Name: Intelligent Breast Exam™ or iBE™

Outcome Measures

Primary Outcome Measures

1. Number of Quadrants With Detected Breast Lesions [3 months]

   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).

2. Sensitivity of iBE Breast Lesion Detection [1 day]

   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

3. Specificity of iBE Breast Lesion Detection [1 day]

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

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	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

• Principal Investigator: Ari Brooks, MD, Abramson Cancer Center of the University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02762565
• Other Study ID Numbers: UPCC 24114
• First Posted: May 5, 2016
• Last Update Posted: Aug 16, 2021
• Last Verified: May 1, 2021

Study Results

Participant Flow

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

Baseline Characteristics

Arm/Group Title	Breast Scanner
Arm/Group Description	PEFS system (Product Name: Intelligent Breast Exam™ or iBE™
Overall Participants	78
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	71 91%
>=65 years	7 9%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	42
Sex: Female, Male (Count of Participants)
Female	77 98.7%
Male	1 1.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 5.1%
Not Hispanic or Latino	69 88.5%
Unknown or Not Reported	5 6.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 2.6%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	27 34.6%
White	44 56.4%
More than one race	0 0%
Unknown or Not Reported	5 6.4%
Region of Enrollment (participants) [Number]
United States	78 100%

Outcome Measures

1. Primary Outcome

Title	Number of Quadrants With Detected Breast Lesions
Description	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).
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Breast Scanner
Arm/Group Description	PEFS system (Product Name: Intelligent Breast Exam™ or iBE™
Measure Participants	78
Measure quadrants	342
Number of quadrants positive for a lesion	77
Number of quadrants negative for a lesion	265

2. Primary Outcome

Title	Sensitivity of iBE Breast Lesion Detection
Description	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
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

quadrants with positive breast lesions

Arm/Group Title	Breast Scanner
Arm/Group Description	PEFS system (Product Name: Intelligent Breast Exam™ or iBE™
Measure Participants	78
Measure quadrants	77
Count of Units [quadrants]	66

3. Primary Outcome

Title	Specificity of iBE Breast Lesion Detection
Description	the number of quadrants characterized normal breast by iBE confirmed by mammogram and ultrasound, 4 quadrants per breast per participant
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

breast quadrants negative for breast lesions

Arm/Group Title	Breast Scanner
Arm/Group Description	PEFS system (Product Name: Intelligent Breast Exam™ or iBE™
Measure Participants	78
Measure quadrants	265
Count of Units [quadrants]	237

Adverse Events

Time Frame	1 week
Arm/Group Title	Breast Scanner
Arm/Group Description	PEFS system (Product Name: Intelligent Breast Exam™ or iBE™
All Cause Mortality
	Breast Scanner
	Affected / at Risk (%)	# Events
Total	0/78 (0%)
Serious Adverse Events
	Breast Scanner
	Affected / at Risk (%)	# Events
Total	0/78 (0%)
Other (Not Including Serious) Adverse Events
	Breast Scanner
	Affected / at Risk (%)	# Events
Total	0/78 (0%)

Limitations/Caveats

[Not Specified]

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.