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Trial registered on ANZCTR


Registration number
ACTRN12617001368325
Ethics application status
Approved
Date submitted
10/04/2017
Date registered
27/09/2017
Date last updated
27/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Magnetic tracer use for sentinel node biopsy: A pilot study
Scientific title
Magnetic tracer verses standard technique for sentinel node biopsy in breast cancer: A single centre pilot study
Secondary ID [1] 291654 0
A+7257
Universal Trial Number (UTN)
U1111-1183-2853
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 302806 0
Condition category
Condition code
Cancer 302303 302303 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a new technique for sentinel node biopsy in breast cancer using magnetic superparamagnetic iron oxide tracer injection (Sienna+®). This tracer is injected (2ml) into the tumour by the operating surgeon in theatre after the patient has been placed under general anaesthetic. A specialised handheld magnetic probe (Sentimag®) is then used to localise the sentinel nodes that have taken up the magnetic tracer. The probe is an approximately 25cm thin cylindrical device that makes a noise when it is close to the magnetic tracer. It is similar to the standard technique currently used when radioisotope is injected and a handheld gamma probe is used, the probe making a noise when it is close to the radioisotope tracer. For study participants they are not aware of the use of these probes as they are under General Anaesthetic. The duration of the procedure can vary from 20minutes to an hour depending on how difficult it is to localise the sentinel node. The two techniques (using sentimag and the standard technique currently used) are performed simultaneously.
Intervention code [1] 297742 0
Treatment: Devices
Intervention code [2] 299198 0
Early detection / Screening
Comparator / control treatment
As this is a pilot study looking at non inferiority of the new technique compared to the current standard technique there is no formal control group. The comparator is the 'standard technique' for sentinel node biopsy in breast cancer currently used in our institution. This includes use of both radioisotope injection and blue dye. For each patient, both the magnetic technique followed by the standard technique will be used, and all involved sentinel nodes located by either/both techniques will be removed.
Control group
Active

Outcomes
Primary outcome [1] 301714 0
Proportion of successful procedures for sentinel lymph node identification (identification rate per patient) by the magnetic method compared with the standard method (radioisotope and patent blue). A successful procedure is defined as localisation of the sentinel node using the specified technique. (If sentinel node is unable to be localised/identified, current practice would mean that a full axillary node clearance is required, i.e. removal of all the fibrofatty tissue in the axilla to remove all the lymph nodes)
Timepoint [1] 301714 0
At completion of both procedures in each participant.
Secondary outcome [1] 333658 0
Feasibility Aim #1: Can we recruit a minimum one patient a week?
Timepoint [1] 333658 0
At the end of the recruitment period
Secondary outcome [2] 333659 0
Feasibility Aim #2: What is the learning curve for the new magnetic technique for individual surgeons in our Unit? Using a short questionnaire for the operating surgeon regarding ease of use of the new technique that will be filled out each time they use the Sentimag.
Timepoint [2] 333659 0
At the end of the study period

Eligibility
Key inclusion criteria
All women over the age of 18 undergoing sentinel node biopsy for breast cancer (invasive or ductal carcinoma, or extensive ductal carcinoma in-situ) with clinically and radiologically node-negative axillae will be eligible to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include patients with allergy to iron or dextran compounds, iron overload disease, pacemaker or ferrous metal-containing devices in the chest wall, pregnancy and lactation.

Study design
Purpose of the study
Diagnosis
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
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This will be a single centre pilot study conducted by the Breast Unit within the department of General Surgery at Auckland District Health Board. We will be trialling this new technique for sentinel lymph biopsy using magnetic tracer (Sienna) and its handheld magnetic localisation probe (SentiMag).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As a pilot study there will be feasibility aims and scientific aims (Refer: “Aims”). Regarding feasibility aim #2, we will collect qualitative data about the operating surgeon’s level of comfort and/or confidence in using the SentiMag as well as ask them to note how many times they have used the SentiMag before.
The primary scientific endpoint for this study will be the proportion of successful procedures for SLN identification (identification rate per patient) by the magnetic method compared with the standard method (radioisotope and patent blue). A successful procedure is defined as detection of at least one magnetic SLN for the magnetic method, and at least one radioactive and/or blue SLN for the standard method.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/09/2017
Actual
Date of last participant enrolment
Anticipated
23/09/2018
Actual
Date of last data collection
Anticipated
23/09/2018
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 8786 0
New Zealand
State/province [1] 8786 0

Funding & Sponsors
Funding source category [1] 296153 0
Commercial sector/Industry
Name [1] 296153 0
EBOS Healthcare
Country [1] 296153 0
New Zealand
Primary sponsor type
Individual
Name
Mr Isaac Cranshaw
Address
Auckland City Hospital, 2 Park Ave, Grafton, 1023, Auckland
Country
New Zealand
Secondary sponsor category [1] 295053 0
None
Name [1] 295053 0
Address [1] 295053 0
Country [1] 295053 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297399 0
Northern B, Health and Disability Ethics Committee
Ethics committee address [1] 297399 0
Ministry of Health Freyberg Building 20 Aitken Street PO Box 5013 Wellington 6011
Ethics committee country [1] 297399 0
New Zealand
Date submitted for ethics approval [1] 297399 0
26/05/2016
Approval date [1] 297399 0
28/09/2016
Ethics approval number [1] 297399 0
16/NTB/97

Summary
Brief summary
Breast cancer is the most common cancer for woman in New Zealand. An important aspect to the management of women with breast cancer is sentinel lymph node (SLN) biopsy. The SLN hypothesis is that migration of tumour cells from the primary tumour metastasizes to one or a few lymph nodes before involving the other lymph nodes.

The current standard technique for SLN biopsy involves the use of radioisotope and/or blue dye tracers injected into the peri-tumour tissue, which will then enter lymphatic channels to passively flow to SLNs. SLNs infiltrated with the radioisotope will be identified using a hand-held probe which makes a loud noise and gives a high count on the probe monitor as it closes in on a ‘hot’ lymph node; SLNs infiltrated with the blue dye will appear unnaturally blue. There are some limitations, however, to the use of these tracers. The use of radioisotope requires nuclear medicine facilities, storage and handling protocols, specialised personnel who have undergone radiation safety education as well as the need for patients to present the day before surgery for injection of the tracer itself. These factors are particularly significant for provincial centres and/or patients living in more isolated areas. The blue dye also tattoos the skin that can sometimes last up to several months and is associated with severe anaphylactoid reactions in 0.1 to 1.1% of patients.

More recently, a new technique for SLN biopsy has been developed using a magnetic superparamagnetic iron oxide tracer (SPIO), injected in a similar fashion to blue dye and localised intraoperatively using a handheld magnetic probe similar to the gamma probe. The SPIO tracer has been in use in clinical practice for over 20 years as intravenous contrast for MRI. The probe responds to the magnetic signal given off by the presence of the tracer.

This will be a single centre pilot study conducted by the Breast Unit within the department of General Surgery at Auckland City Hospital. We will be trialling this new technique for sentinel lymph biopsy using magnetic tracer (Sienna) and its handheld magnetic localisation probe (SentiMag) in addition to the current standard technique (radioisotope and blue dye). The radiotracer and blue dye will be administered as per the current practice as well as the magnetic tracer. This pilot study will have the following feasibility aims and scientific aims. 1. Feasibility – recruitment: Can we recruit at a minimum one patient a week?
2. Feasibility – resources: What is the learning curve for this new technique for individual surgeons in our Unit?
3. Scientific – primary endpoint: proportion of successful procedures for SLN identification (identification rate per patient) by the magnetic method compared with the standard method (radioisotope and patent blue).
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1623 1623 0 0
/AnzctrAttachments/372716-SENTIMAG_PISandCF_version 3_27112016.pdf (Participant information/consent)

Contacts
Principal investigator
Name 73922 0
Mr Isaac Cranshaw
Address 73922 0
Auckland City Hospital, 2 Park Ave, Grafton, 1023, Auckland
Country 73922 0
New Zealand
Phone 73922 0
+6421938381
Fax 73922 0
Email 73922 0
[email protected]
Contact person for public queries
Name 73923 0
Alexandra Jacobson
Address 73923 0
Auckland City Hospital, 2 Park Ave, Grafton, 1023, Auckland
Country 73923 0
New Zealand
Phone 73923 0
+64212579447
Fax 73923 0
Email 73923 0
[email protected]
Contact person for scientific queries
Name 73924 0
Isaac Cranshaw
Address 73924 0
Auckland City Hospital, 2 Park Ave, Grafton, 1023, Auckland
Country 73924 0
New Zealand
Phone 73924 0
+6421938381
Fax 73924 0
Email 73924 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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