Breast Cancer Clinical Trial
— ENCASeOfficial title:
Evaluation of Needle Core Biopsy of Axillary Sentinel Lymph Node in Breast Cancer
Verified date | October 2023 |
Source | Loma Linda University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to determine if it is possible to identify and perform a needle biopsy of the sentinel lymph node. The investigators hope to identify breast cancer cells in the lymph nodes under the arm without making an operation necessary. The rationale for this study is that for patients without enlarged lymph nodes under the arm, sentinel lymph node biopsy is the standard way of determining if breast cancer has spread to the lymph nodes under the arm. While the complications from a sentinel lymph node dissection are less than that of a complete axillary lymph node dissection, sentinel lymph node dissection still carries small risks of arm swelling, decreased movement, fluid collections, nerve injury, and pain. Furthermore, the majority of sentinel lymph nodes do not contain cancer. The investigators hope to develop a method to find cancer in the axillary lymph nodes and avoid the complications of an operation.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | December 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Breast cancer patients eligible for sentinel node dissection - Invasive ductal or invasive lobular carcinoma - Ductal carcinoma in situ undergoing total mastectomy - Clinically node-negative - 18-100 years Exclusion Criteria: - Inflammatory breast cancer - Pregnant or lactating - Preoperative chemotherapy - Prior axillary ultrasound guided core needle biopsy |
Country | Name | City | State |
---|---|---|---|
United States | Loma Linda University Medical Center | Loma Linda | California |
Lead Sponsor | Collaborator |
---|---|
Loma Linda University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of axillary ultrasound guided percutaneous needle biopsy of sentinel node | False positive and false negative rates of ultrasound guided needle biopsy of sentinel node will be determined by comparison of results with gold standard of open surgical sentinel node dissection. | 2 years |
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