Breast Cancer Clinical Trial
A Study to Compare the Effectiveness of Two Types of Ultrasound Technologies in Women Who Have Had Breast Cancer
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.
Full 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.
Eligibility Criteria
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 within the last five years
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 > 5 years prior to study enrollment
Bilateral NSM or SSM with reconstruction
Females who are pregnant
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There is 1 Location for this study
Philadelphia Pennsylvania, 19107, United States More Info
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