N/A
N=89
Clinical Utility of a Low-Cost Hand-Held Breast Scanner
Symptomatic Breast Lump
Bottom Line
View on ClinicalTrials.gov: NCT02762565 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Number of Quadrants With Detected Breast Lesions — 77; 265 quadrants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PEFS system (Product Name: Intelligent Breast Exam™ or iBE™ (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Quadrants With Detected Breast Lesions |
77; 265 | — |
| PRIMARY Sensitivity of iBE Breast Lesion Detection |
66 | — |
| PRIMARY Specificity of iBE Breast Lesion Detection |
237 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02762565). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.