Status:
UNKNOWN
Comparison Trial of Open-tip Pulsed Needle Biopsy and Conventional Core Biopsy in Axillary Lymph Nodes
Lead Sponsor:
NeoDynamics AB
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The aim of the study is to compare performance and safety of a newly developed 14-gauge open-tip pulsed biopsy needle with a conventional 14-gauge core biopsy needle for sampling of radiologically ind...
Detailed Description
It is the standard of care in the United Kingdom for women with suspected or confirmed breast cancer to undergo ultrasound of the ipsilateral axilla prior to surgery in order to detect nodal metastati...
Eligibility Criteria
Inclusion
- Women in screening and symptomatic clinics aged 18 years or older with breast masses scored as 1 of the following:
- M3, M4 or M5 (mammographically uncertain, suspicious or highly suspicious of malignancy)
- MRI5 (highly suspicious of malignancy on MRI)
- U3, U4 or U5 (ultrasonically uncertain, suspicious or highly suspicious of malignancy)
- have histologically proven breast cancer
- who have ipsilateral axillary lymph nodes which are described as indeterminate or suspicious for metastatic disease and indicated for biopsy, as determined by individual breast unit criteria
- are able to give informed consent for the study
Exclusion
- Previous ipsilateral axillary surgery
- Target lymph node not suitable for needle biopsy due to its close proximity to critical structures such as major blood vessels
- Unable to give written informed consent in English
Key Trial Info
Start Date :
July 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
479 Patients enrolled
Trial Details
Trial ID
NCT04500262
Start Date
July 13 2020
End Date
March 31 2025
Last Update
June 1 2023
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Basildon University Hospital
Basildon, United Kingdom, SS16 5NL
2
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
3
Thirlestaine Breast Centre, Gloucestershire Hospitals NHS Foundation
Cheltenham, United Kingdom, GL53 7AS
4
Darlington Memorial Hospital
Darlington, United Kingdom, DL36HX