Clinical trial · Interventional
A Study to Compare the Effectiveness of Two Types of Ultrasound Technologies in Women Who Have Had Breast Cancer
Feasibility of Automated Breast Ultrasound (ABUS) Versus Handheld Ultrasound (HHUS) for Breast Cancer Surveillance in Women With Nipple Sparing or Skin Sparing Mastectomy With Reconstruction
- 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 evaluates automated breast ultrasound (ABUS) and handheld ultrasound (HHUS) for the screening of women who have undergone breast reconstruction after breast cancer. Ultrasounds use high-frequency sound waves to create pictures of internal organs and tissues. ABUS has been found to be equal to HHUS for whole breast screening, but no data exist on its use for screening of reconstructed patients. This clinical trial evaluates the feasibility of using ABUS versus HHUS to screen women who have undergone reconstruction.
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 |
|---|---|---|---|
| Malignant Breast Neoplasm | Malignant Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Automated Breast Ultrasound | Procedure | — | UNRESOLVED |
| Ultrasonography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Screening (automated breast ultrasound, handheld ultrasound)
- description
- Participants undergo HHUS and ABUS in no required order over 1 hour.
- interventionNames
- Procedure: Ultrasonography
- Procedure: Automated Breast Ultrasound
Primary outcomes (1)
- measure
- Detection of the residual tissue (i.e., artifact) in reconstructed nipple sparing mastectomy (NSM) and skin sparing mastectomy (SSM) patients by automated breast ultrasound (ABUS) and handheld ultrasound (HHUS)
- timeFrame
- Up to 1 year
- description
- This is a binary endpoint. The rate of artifact will be compared between handheld and automated scanning using McNemar test.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female * \>= 18 years of age at time of consent * Free of focal breast symptoms and with no suspicious breast physical exam findings * Previous unilateral NSM or SSM with implant (silicone, saline) or flap reconstruction performed at Thomas Jefferson University Hospital * Must be able to understand and provide signed and dated informed consent form. If a patient understands the informed consent but is unable to sign, a legally authorized representative (LAR) may sign * Willing to comply with all study procedures and be available for the duration of the study * Willing to honor any bills that may be incurred if the insurance company does not pay for the billed bilateral hand held ultrasound Exclusion Criteria: * History of breast cancer recurrence * Current focal breast symptoms since NSM or SSM with reconstruction * NSM or SSM with reconstruction was performed years prior to study enrollment * Bilateral NSM or SSM with reconstruction * Females who are pregnant
References
Publications (0)
Data not yet available