Clinical trial · Interventional
Clinical Utility Study of a Low-Cost Hand-Held Breast Scanner
NCT02597452CI-TRIAL-00044474iBEcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intelligent Breast Exam, iBE | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- intelligent Breast Exam, iBE
- description
- Single Arm: Additional breast exam by a FDA approved hand-held intelligent breast exam device and a clinical breast exam during their scheduled breast screening appointment. No return visit required for participation.
- interventionNames
- Device: intelligent Breast Exam, iBE
Primary outcomes (2)
- measure
- Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results
- timeFrame
- approximately one month after imaging scan
- description
- comparing the calculated the sensitivities or the percentage of true positive breast lesions (based on imaging results) of the iBE and CBE
- measure
- Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDClanahan JM, Reddy S, Broach RB, Rositch AF, Anderson BO, Wileyto EP, Englander BS, Brooks AD. Clinical Utility of a Hand-Held Scanner for Breast Cancer Early Detection and Patient Triage. JCO Glob Oncol. 2020 Feb;6:27-34. doi: 10.1200/JGO.19.00205. PMID 32031433