None listed
Conditions
Brief summary
This study aims to evaluate the efficacy of Savi Scout® a radar localisation (RL) device in localising non-palpable breast lesion and axillary marking Who is it for? You may be eligible to join this study if you are aged 18 years and older, and have non-palpable breast cancer/breast lesions Study details Participants will be allocated to the intervention group if they consent for participation. Otherwise, they will be allocated to the control group. Participants in the intervention group will undergo RL using the Savi Scout® device to determine tissue margins prior to surgery while the control group will undergo standard of care wire localisation (WL) using Kopans hookwire to determine tissue margins prior to surgery. Participants will be followed-up postoperatively within one month following surgery to assess accuracy of margins, the outcome of a Multidisciplinary Meeting to determine the next step in cancer management. It is hoped that this research project will provide useful information about whether RL is a cost-effective intervention compared to traditional WL.
Interventions
Radar localisation is a wireless localisation technique which involves using SAVI SCOUT® radar localisation. This involves insertion of a tiny electromagnetic wave reflector into the target tissue using an introducer needle delivery system under mammogram or ultrasound guidance by an interventional breast radiologist. The reflector is activated by infrared light impulses generated by the console probe and uses two antennas to reflect an electromagnetic wave signal back to the handpiece to provid
Radar localisation is a wireless localisation technique which involves using SAVI SCOUT® radar localisation. This involves insertion of a tiny electromagnetic wave reflector into the target tissue using an introducer needle delivery system under mammogram or ultrasound guidance by an interventional breast radiologist. The reflector is activated by infrared light impulses generated by the console probe and uses two antennas to reflect an electromagnetic wave signal back to the handpiece to provide real-time directionality and proximity information. The allocated duration of the insertion of the device is one hour. It will be scheduled at least one day prior to the surgery date. The trial is non-randomised. Participants will be allocated to the intervention group if they consent for participation. Otherwise, they will be allocated to the control group. Participants in the intervention group will undergo RL using the Savi Scout® device while the control group will undergo standard of care wire localisation (WL) using Kopans hookwire.
Sponsors
National Breast Cancer Foundation
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Patients undergoing a wide local excision for a non-palpable breast lesion using SAVI SCOUT - Patients undergoing a targeted axillary lymph node dissection or axillary lymph node dissection for an axillary lesion using SAVI SCOUT - 18 years of age - Female - Willing to participate in the study
Exclusion criteria
- Pregnancy - Unwilling to provide consent
Outcome results
None listed