N/A
Completed N=516
Clinical Utility Study of a Low-Cost Hand-Held Breast Scanner
Source: ClinicalTrials.gov NCT02597452 ↗Enrolled (actual)
516
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcomePrimary: 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
Summary
The primary purpose of this study is to measure the clinical utility (accuracy) of the hand-held breast scanner (iBE) for the detection of breast lesions or lumps. The iBE results will be compared to the results of a current mammogram and/or ultrasound. The duration of study participation is approximately 30 minutes one day.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results |
34.3 | — |
| PRIMARY Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results |
80.3 | — |
| SECONDARY Position of the Breast Lesion as Measured by iBE and Mammography |
4 | — |
| SECONDARY Size Detection of the Breast Lesions Identified by iBE |
— | — |
| SECONDARY Inter-rate Reliability of the iBE and the CBE Number of Lesions Detected |
— | — |
| SECONDARY Inter-rate Reliability of the iBE and the CBE Position of Lesions Detected |
— | — |
| SECONDARY Post-stratification of the Analysis of the Reliability by Breast Imaging Reporting and Data System Level |
12; 362; 89; 23 | — |
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 (NCT02597452). 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. Informational only — not medical advice.