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| ID | Type | Description | Link |
|---|---|---|---|
| JT 14405 | Other Identifier | JeffTrial Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening (automated breast ultrasound, handheld ultrasound) | Experimental | Participants undergo HHUS and ABUS in no required order over 1 hour. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasonography | Procedure | Undergo HHUS |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | This is a binary endpoint. The rate of artifact will be compared between handheld and automated scanning using McNemar test. | Up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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| Automated Breast Ultrasound |
| Procedure |
Undergo ABUS |
|
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D055585 |
| Physical Phenomena |