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The primary aim of this prospective, multicentre study is to determine whether the involved node can be marked using black carbon dye and successfully identified at the time of surgery. The secondary aims are to determine the concordance between the tattooed node and sentinel node, migration of black dye into other nodes, and false-negative rate of tattooed node (in patients undergoing ALND after NACT).
Pretreatment evaluation of axillary lymph nodes and marking of biopsied nodes in patients with newly diagnosed breast cancer is becoming routine practice. Tagging of biopsied axillary lymph nodes with metal markers, similar to what is done for suspicious breast lesions, is being adopted in clinical practice. The need to mark a positive axillary lymph node becomes especially relevant in cases where neoadjuvant chemotherapy (NACT) is anticipated so that these nodes may be identified at the time of surgery. Measures that improve both the accuracy of nodal evaluation after NACT and the ability to assess treatment response are desirable in order to tailor therapies for breast cancer treatment. The investigators sought to test tattooing of biopsied axillary lymph nodes with a sterile black carbon suspension.
Age
18 - 70 years
Sex
FEMALE
Healthy Volunteers
No
Study Officials
Fuzhou, Fujian, China
Start Date
March 1, 2020
Primary Completion Date
December 31, 2022
Completion Date
March 31, 2023
Last Updated
August 23, 2022
200
ESTIMATED participants
carbon dye
DRUG
Lead Sponsor
Fujian Medical University Union Hospital
NCT04550494
NCT05245812
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