Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000068561
Ethics application status
Approved
Date submitted
20/10/2023
Date registered
25/01/2024
Date last updated
25/01/2024
Date data sharing statement initially provided
25/01/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Radar localisation of breast and axillary lesions with SCOUT: A prospective single institution pilot study
Scientific title
Cost-effectiveness of radar localisation versus wire localisation for wide local excision of non-palpable breast cancer
Secondary ID [1] 310796 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Localisation of non-palpable breast lesions 331778 0
Condition category
Condition code
Cancer 328517 328517 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 327209 0
Treatment: Surgery
Intervention code [2] 327318 0
Treatment: Devices
Comparator / control treatment
Wire localisation involves the Kopans wire, a stainless steel 0.3 mm diameter wire with a proximal reinforced portion and a spring hook to anchor to the tissue surrounding the lesion. The reinforced portion provides a visual and palpable landmark to allow the surgeon to judge the distance to the lesion during dissection. Preoperative localisation involves a planning ultrasound to locate the lesion. After local anaesthesia, and under ultrasound guidance, the hookwire will be advanced through the lesion and the needle deployed by an interventional breast radiologist. Four to 6 cm of the wire was left to protrude from the skin and a mammogram will be used to confirm the position following the procedure. The allocated duration of the insertion of the device is one hour. It will be scheduled within 24-48 hours of the surgery date.
Control group
Active

Outcomes
Primary outcome [1] 336348 0
Cost-effectiveness
Timepoint [1] 336348 0
Assessed at the day of surgery
Primary outcome [2] 336483 0
Margin status
Timepoint [2] 336483 0
Following multi-disciplinary meeting outcome within one month postoperative.
Primary outcome [3] 336484 0
Re-excision rates
Timepoint [3] 336484 0
Following multi-disciplinary meeting outcome within one month postoperative.
Secondary outcome [1] 427957 0
Rate of successful SCOUT reflector placement for both breast and axillary surgery.
Timepoint [1] 427957 0
Obtained at the time of reflector placement.
Secondary outcome [2] 428543 0
Rate of successful intraoperative lesion localisation using SCOUT for breast surgery.
Timepoint [2] 428543 0
Obtained during surgery following excision of the target lesion and post-procedure X-RAY immediately after excision of the lesion.
Secondary outcome [3] 429016 0
Rate of successful intraoperative lesion localisation using SCOUT for axillary surgery.
Timepoint [3] 429016 0
Obtained during surgery following excision of the target lesion and post-procedure X-RAY immediately after excision of the lesion.
Secondary outcome [4] 429017 0
Rate of successful intraoperative reflector retrieval of SCOUT for breast surgery.
Timepoint [4] 429017 0
Obtained during surgery following excision of the target lesion and post-procedure X-RAY immediately after excision of the lesion.
Secondary outcome [5] 429018 0
Rate of successful intraoperative reflector retrieval of SCOUT for axillary surgery.
Timepoint [5] 429018 0
Obtained during surgery following excision of the target lesion and post-procedure X-RAY immediately after excision of the lesion.
Secondary outcome [6] 429019 0
Weight of specimen
Timepoint [6] 429019 0
Within one month postoperative.
Secondary outcome [7] 429020 0
Volume of specimen
Timepoint [7] 429020 0
Within one month postoperative.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnancy
- Unwilling to provide consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/02/2021
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
220
Accrual to date
110
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25758 0
Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 41584 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 315035 0
Charities/Societies/Foundations
Name [1] 315035 0
National Breast Cancer Foundation
Country [1] 315035 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
National Breast Cancer Foundation
Address
7/50 Margaret St, Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 317598 0
None
Name [1] 317598 0
Address [1] 317598 0
Country [1] 317598 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313996 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 313996 0
Research Ethics and Governance Office (REGO) Royal Prince Alfred Hospital Missenden Road CAMPERDOWN NSW 2050
Ethics committee country [1] 313996 0
Australia
Date submitted for ethics approval [1] 313996 0
01/12/2020
Approval date [1] 313996 0
01/01/2021
Ethics approval number [1] 313996 0
PID00441/ETH00392

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130062 0
A/Prof Sanjay Warrier
Address 130062 0
Department of Breast Surgery, Chris O’Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050, Australia
Country 130062 0
Australia
Phone 130062 0
+61 401608581
Fax 130062 0
Email 130062 0
[email protected]
Contact person for public queries
Name 130063 0
Sanjay Warrier
Address 130063 0
Department of Breast Surgery, Chris O’Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050, Australia
Country 130063 0
Australia
Phone 130063 0
+61 401608581
Fax 130063 0
Email 130063 0
[email protected]
Contact person for scientific queries
Name 130064 0
Sanjay Warrier
Address 130064 0
Department of Breast Surgery, Chris O’Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050, Australia
Country 130064 0
Australia
Phone 130064 0
+61 401608581
Fax 130064 0
Email 130064 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.