Clinical trial · Interventional
Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer
Clinical Data Collection for Initial Evaluation of SoftVue: a Novel Ultrasound Breast Scanner
NCT01698658CI-TRIAL-00058731completedN/AClinicalTrials.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)
This clinical trial studies ultrasound tomography using SoftVue in diagnosing women with breast cancer. New diagnostic procedures, such as ultrasound tomography using SoftVue, may help find and diagnose breast cancer.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| magnetic resonance imaging | Procedure | — | UNRESOLVED |
| ultrasound tomography | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (SoftVue ultrasound tomography)
- description
- Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the breast.
- interventionNames
- Other: ultrasound tomography
- Procedure: magnetic resonance imaging
Primary outcomes (1)
- measure
- Evaluation the SoftVue system with respect to spatial resolution, contrast, sound speed resolution, and attenuation resolution
- timeFrame
- At time of procedure
- description
- For each type of resolution, observed values will be averaged over slices for each participant and compared to milestone values. The proportion of individuals whose images meet the milestone criteria will be reported with 95% confidence intervals calculated using Wilson's method.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: * Scheduled for mammogram, breast ultrasound and/or breast MRI * Breast size less than 22 cm diameter (ring diameter is 22cm) * Able to read or understand and provide informed consent * Weight \< 350lbs (patient bed max weight) * Non-pregnant and non-lactating * No open breast or chest wounds * No active skin infection * No serious medical or psychiatric illnesses that would prevent informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.