Trial Outcomes & Findings for Study of iBreast, a Handheld Device to Detect Breast Abnormalities During Screening Visits for Breast Cancer (NCT NCT04761055)
NCT ID: NCT04761055
Last Updated: 2026-07-30
Results Overview
comparing the calculated the specificities or the percentage of true negative lesions (based on imaging results) of the iBE and CBE
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
300 participants
Primary outcome timeframe
approximately one month after imaging scan
Results posted on
2026-07-30
Participant Flow
Participant milestones
| Measure |
Screening Visits for Breast Cancer
Consenting patients will receive their already scheduled standard CBE and mammogram and in addition will receive a breast exam utilizing the iBreast Exam (iBE).
|
|---|---|
|
Overall Study
STARTED
|
300
|
|
Overall Study
COMPLETED
|
300
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of iBreast, a Handheld Device to Detect Breast Abnormalities During Screening Visits for Breast Cancer
Baseline characteristics by cohort
| Measure |
Screening Visits for Breast Cancer
n=300 Participants
Consenting patients will receive their already scheduled standard CBE and mammogram and in addition will receive a breast exam utilizing the iBreast Exam (iBE).
|
|---|---|
|
Age, Continuous
|
58.9 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
300 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
125 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
175 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
151 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
81 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
59 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
300 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: approximately one month after imaging scancomparing the calculated the sensitivities or the percentage of true positive breast lesions (based on imaging results) of the iBE and CBE
Outcome measures
| Measure |
Screening Visits for Breast Cancer
n=300 Participants
Consenting patients will receive their already scheduled standard CBE and mammogram and in addition will receive a breast exam utilizing the iBreast Exam (iBE).
|
|---|---|
|
Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results
iBE Examinations
|
0.111 % of true positive breast lesions
Interval 0.003 to 0.482
|
|
Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results
Clinical Breast Examinations (CBE)
|
0.111 % of true positive breast lesions
Interval 0.003 to 0.482
|
PRIMARY outcome
Timeframe: approximately one month after imaging scancomparing the calculated the specificities or the percentage of true negative lesions (based on imaging results) of the iBE and CBE
Outcome measures
| Measure |
Screening Visits for Breast Cancer
n=300 Participants
Consenting patients will receive their already scheduled standard CBE and mammogram and in addition will receive a breast exam utilizing the iBreast Exam (iBE).
|
|---|---|
|
Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results
iBE Examinations
|
1.000 % of true negative lesions
Interval 0.987 to 1.0
|
|
Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results
Clinical Breast Examinations (CBE)
|
0.997 % of true negative lesions
Interval 0.981 to 1.0
|
Adverse Events
Screening Visits for Breast Cancer
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. Victoria Mango, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4622
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place