Malignant Breast Neoplasm
Conditions
Brief summary
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.
Detailed description
PRIMARY OBJECTIVE: I. To show that ABUS reduces artifact compared to HHUS in terms of detection of the residual tissue in reconstructed nipple sparing mastectomy (NSM) and skin sparing mastectomy (SSM) patients. SECONDARY OBJECTIVES: I. To evaluate both the performance and interpretation times for ABUS and HHUS so that these factors can be considered when scheduling patients and for ease of implementation into practice. II. A short survey will be administered immediately after both ultrasounds performed to enrolled patients to assess their experience with HHUS and ABUS, specifically addressing their perceived comfort level on a numerical scale and if they would be interested in obtaining subsequent annual screening HHUS or ABUS. EXPLORATORY OBJECTIVE: I. The appearance of native and reconstructed anatomy on ABUS and HHUS will be studied. OUTLINE: Participants undergo HHUS and ABUS in no required order over 1 hour. Participants with ultrasound results indicating Breast Imaging Reporting and Data System (BI-RADS) 4 or 5 (suspicious and needs biopsy) undergo biopsy within 30 days.
Interventions
PROCEDUREUltrasonography
Undergo HHUS
PROCEDUREAutomated Breast Ultrasound
Undergo ABUS
Sponsors
Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Up to 1 year | This is a binary endpoint. The rate of artifact will be compared between handheld and automated scanning using McNemar test. |
Countries
United States
Outcome results
None listed