Breast Cancer Clinical Trial
— pre-ATNECOfficial title:
Pre-ATNEC - A Multicentre Prospective Feasibility Study of Carbon Dye Tattooing of Biopsied Axillary Node and Surgical Localisation in Breast Cancer Patients
NCT number | NCT03640819 |
Other study ID # | 241379 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 27, 2018 |
Est. completion date | July 31, 2019 |
Verified date | October 2020 |
Source | University Hospitals of Derby and Burton NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 100 |
Est. completion date | July 31, 2019 |
Est. primary completion date | July 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age = 18 - Male or female - Patients scheduled to undergo routine fine needle aspiration (FNA) or core biopsy of abnormal axillary lymph node - Invasive breast cancer - Written informed consent for the study Exclusion Criteria: - Not undergoing surgery or unfit for surgery |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Derby Hospital | Derby |
Lead Sponsor | Collaborator |
---|---|
University Hospitals of Derby and Burton NHS Foundation Trust |
United Kingdom,
Goyal A, Puri S, Marshall A, Valassiadou K, Hoosein MM, Carmichael AR, Erdelyi G, Sharma N, Dunn J, York J. A multicentre prospective feasibility study of carbon dye tattooing of biopsied axillary node and surgical localisation in breast cancer patients. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification rate of tattooed node | Proportion of patients in whom tattooed node/s were identified. | 12 months | |
Secondary | Concordance of tattooed node and sentinel node | Concordance rate: defined as the percent of patients in whomthe tattooed node is the sentinel node. | 12 months | |
Secondary | Migration of black dye into other nodes | The number of black nodes at the time of sentinel node biopsy or axillary lymph node dissection. | 12 months |
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