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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]

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

Condition category

Condition code

Cancer

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]

Treatment: Devices

Intervention code [2]

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]

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]

At completion of both procedures in each participant.

Secondary outcome [1]

Feasibility Aim #1: Can we recruit a minimum one patient a week?

Timepoint [1]

At the end of the recruitment period

Secondary outcome [2]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

EBOS Healthcare

Address [1]

108 Wrights Road, Addington, Christchurch, 8024, New Zealand

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern B, Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health Freyberg Building 20 Aitken Street PO Box 5013 Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

26/05/2016

Approval date [1]

28/09/2016

Ethics approval number [1]

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]

/AnzctrAttachments/372716-SENTIMAG_PISandCF_version 3_27112016.pdf (Participant information/consent)

Contacts

Principal investigator

Name

Mr Isaac Cranshaw

Address

Auckland City Hospital, 2 Park Ave, Grafton, 1023, Auckland

Country

New Zealand

Phone

+6421938381

Fax

[email protected]

Contact person for public queries

Name

Alexandra Jacobson

Address

Auckland City Hospital, 2 Park Ave, Grafton, 1023, Auckland

Country

New Zealand

Phone

+64212579447

Fax

[email protected]

Contact person for scientific queries

Name

Isaac Cranshaw

Address

Auckland City Hospital, 2 Park Ave, Grafton, 1023, Auckland

Country

New Zealand

Phone

+6421938381

Fax

[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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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