Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Thomas Jefferson University
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
