Status:
COMPLETED
A Study to Compare the Effectiveness of Two Types of Ultrasound Technologies in Women Who Have Had Breast Cancer
Lead Sponsor:
Thomas Jefferson University
Conditions:
Malignant Breast Neoplasm
Eligibility:
FEMALE
18+ years
Phase:
NA
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...
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 (SS...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05408260
Start Date
November 18 2022
End Date
February 17 2025
Last Update
January 5 2026
Active Locations (1)
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1
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107