Clinical trial · Interventional
Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Breast Cancer Screening
A Prospective, Single-Center, Feasibility Study Assessing the Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Identifying Malignant Breast Lesions as an Adjunct to Mammography
NCT04102722CI-TRIAL-00042825unknownN/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 is a single-center, pilot study being conducted to evaluate the safety and performance of the investigational device (MUST) in detecting malignant lesions in breast tissue.
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 Screening | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MUST device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- description
- All enrolled subjects will undergo breast cancer screening with mammography and the MUST device
- interventionNames
- Device: MUST device
Primary outcomes (2)
- measure
- Number of subjects with true positive (malignant) breast lesions confirmed by biopsy
- timeFrame
- 14 days
- description
- Sensitivity of MUST plus mammography versus mammography alone
- measure
- Number of subjects with false positive (benign) breast lesions confirmed by biopsy
- timeFrame
- 14 days
- description
- Specificity of MUST plus mammography versus mammography alone
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female subject scheduled for routine screening mammogram 2. Not currently pregnant or breastfeeding 3. Age 40 to 74 years, inclusive 4. Weight less than 115 kg 5. Able to provide written informed consent 6. Willing to comply with study protocol and follow-up recommendations. Exclusion Criteria: 1. Breast implants 2. Signs or symptoms of breast disease including changes in the size or shape of breast tissue, palpable lump, bloody or spontaneous clear nipple discharge, and/or eczema of the nipple 3. Weeping rash, open wounds, or unhealed sores on the breast 4. Bilateral mastectomy or unilateral mastectomy 5. Unable to lay prone on the scan table for up to 16 minutes 6. Unable to have breast positioned into the MUST device 7. Any breast surgeries in the past 12 months 8. History of cancer diagnosis and/or treatment in the past 5 years. 9. Unable or unwilling to undergo MRI if indicated
References
Publications (0)
Data not yet available
No reference posted for this study.