Ultrasound Guided Core Biopsy vs Fine Needle Aspiration for Evaluation of Axillary Lymphadenopathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01920139|
Recruitment Status : Completed
First Posted : August 9, 2013
Last Update Posted : August 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Focus: Breast Cancer With Axillary Node Metastasis||Procedure: Fine needle aspiration and core biopsy of lymph node Procedure: Axillary surgery Other: Titanium marker||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ultrasound Guided Core Biopsy vs Fine Needle Aspiration for Evaluation of Axillary Lymphadenopathy in Patients Suspected of Having Breast Cancer.|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
Breast cancer and Axillary Adenopathy
Women with breast cancer with abnormal appearing ipsilateral axillary nodes undergoing fine needle aspiration and core biopsy of a lymph node.
Procedure: Fine needle aspiration and core biopsy of lymph node
Ultrasound guided fine needle aspiration of an abnormal lymph node followed by ultrasound guided core biopsy of the same node followed by clip placement into the node.
Procedure: Axillary surgery
Patients underwent axillary node dissection or excision of setinel axillary nodes at the time of surgical treatment of their breast cancer.
Other: Titanium marker
A titanium marker was deposited into the lymph node that was percutaneously biopsied , immediately after the last tissue sample obtained.
- Fraction of metastatic nodes found at axillary surgery that were identified pre-surgically by FNA vs. core biopsy [ Time Frame: 1 week to 10 months ]Results of FNA cytology and core biopsy histology are compared to axillary surgery results.
- Pain associated with each type of percutaneous biopsy procedure [ Time Frame: immediate at time of biopsy ]Patients were asked to report pain level during the 2 types of percutaneous biopsy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920139
|United States, Pennsylvania|
|Magee Womens Hospital|
|Pittsburgh, Pennsylvania, United States, 15213|