A Study to Compare the Effectiveness of Two Types of Ultrasound Technologies in Women Who Have Had Breast Cancer
Completed · Not applicable
Conditions studied: Malignant Breast Neoplasm
In brief
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.
Key facts
- Study ID
- NCT05408260
- Run by
- Thomas Jefferson University
- People needed
- 12
- Starts
- 2022-11-18
- Expected to finish
- 2025-02-17
- Last updated by the study team
- 2026-01-05
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify 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 qualify 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
- Bilateral NSM or SSM with reconstruction
- Females who are pregnant
Where it is running
- Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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