Condition category
Cancer
Date applied
13/11/2014
Date assigned
15/12/2014
Last edited
31/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Breast cancer refers to a condition where tumours develop in the tissue of the breast. In the UK, 49,500 women are diagnosed with breast cancer every year. Sentinel lymph nodes are those lymph nodes where a cancer is most likely to spread to first. Sentinal Lymph Node Biopsy (SLNB) is a procedure that helps determine the extent of the cancer, or how advanced it is. The standard surgical technique for SLNB is the ‘dual’ technique. It consists of a radioisotope injection and an injection of blue dye into the breast. Any sentinel nodes are then found using a gamma probe device. Worldwide, access to SLNB is limited by the lack of availability of the radioisotopes. Only about 60% of patients in developed countries have access to this procedure. In China only 5% of patients have access and in the remaining countries it is more or less unavailable. Patients without access to SLNB have to undergo a bigger operation which carries a 20% risk of permanent swelling of the arm (lymphoedema). The aim of this study is to test a new magnetic technique for SLNB in breast cancer patients compared with the standard dual technique. The new technique consists of an injection of a magnetic tracer into the breast. A hand-held device (a magnetometer) is then used to find any sentinel nodes during the operation. The study will compare the performance of both techniques, any illness caused by either technique, and any progression of the breast cancer disease afterwards.

Who can participate?
Patients diagnosed with breast cancer and undergoing a SLNB.

What does the study involve?
Patients are randomly allocated into one of two groups. Those in group 1 are treated using the magnetic technique for SLNB. Those in group 2 are treated using the standard technique for SLNB. The number of sentinel lymph nodes found is recorded for both the standard technique and the magnetic technique.

What are the possible benefits and risks of participating?
Research is an important part of improving the quality of medical care and developing new and innovative treatments. This research will have no direct benefit for the research participants but by taking part in this study we hope to improve other patients’ treatment in the near future. Skin discolouration has been observed in previous studies but it tends to resolve on its own. The magnetic tracer can cause an artefact on subsequent breast MR imaging. There is a chance of developing adverse reactions to the magnetic tracer. Hypersensitivity reactions (rash, itching, dizziness, light-headedness) have been observed in less than 1% of patients with similar tracers (or MRI contrast agents). In this study, the chance of developing adverse reactions to the magnetic tracer are very low as a lower dose is used. It is injected locally into the skin and most of the tracer is surgically removed when the tumour and lymph nodes are removed.

Where is the study run from?
Guy's & St Thomas' Foundation NHS Trust (UK).

When is the study starting and how long is it expected to run for?
January 2015 to January 2020.

Who is funding the study?
J P Moulton Charitable Foundation (UK).

Who is the main contact?
Mr Michael Douek

Trial website

Contact information

Type

Scientific

Primary contact

Mr Michael Douek

ORCID ID

Contact details

Guy's & St Thomas' Foundation NHS Trust
Research Oncology
3rd Floor Bermondsey Wing
Great Maze Pond
London
SE1 9RT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

MAGnetic versus STAndard technique for sentinel node biopsy in breast cancer: a Randomised controlled trial

Acronym

MAGSTAR

Study hypothesis

The standard Sentinel Lymph Node Biopsy (SLNB) technique (blue dye and radioisotope) used in breast cancer patients has several drawbacks. The use of radioisotope exposes patients and healthcare workers to radiation and is heavily controlled by legislation (both on the specific training for operators and subsequent disposal of surgical waste).

The MAGSTAR trial compares a new technique for SLNB versus the standard technique. This new technique uses two devices: an injection of a magnetic tracer (Sienna+, Endomagnetics Ltd, UK) and the use of a hand-held device (a magnetometer, SentiMag, Endomagnetics Ltd, UK) to detect the sentinel node(s) intraoperatively.

Ethics approval

NRES Committee London - Fulham Ethics, 05/03/2015, ref: 15/LO/0289

Study design

Phase III randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet.

Condition

Breast cancer

Intervention

SLNB with the standard combined technique (blue dye and radioisotope) or the new technique (magnetic tracer and hand-held magnetometer). Interventions are the injection of the radioisotope, blue dye and magnetic tracer. Furthermore, the detection and localization of the sentinel lymph node with gammaprobe (standard arm) or the hand-held magnetometer (magnetic arm).

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Overall SLNB identification rate (proportion of successful SLNBs) with either the standard or the new technique
2. SLNB identification rate within the cohort of patients with involved nodes

Secondary outcome measures

1. Morbidity from SLNB (including staining and lymphoedema rate)
2. Locoregional recurrence
3. Cost effectiveness (health economics)
4. Patient-reported outcome measures (PROMS) with both techniques

Overall trial start date

01/01/2015

Overall trial end date

01/01/2020

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with breast cancer scheduled for SLNB and who are clinically and radiologically node negative

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

924

Participant exclusion criteria

1. Known intolerance/hypersensitivity to iron or dextran compounds
2. Patients who decline to receive radioisotope for SLNB
3. Patients with a pacemaker or other implantable devices in the chest wall

Recruitment start date

01/01/2015

Recruitment end date

01/01/2020

Locations

Countries of recruitment

Netherlands, United Kingdom

Trial participating centre

Guy's & St Thomas' Foundation NHS Trust
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

Guy's & St Thomas' Foundation NHS Trust (UK)

Sponsor details

c/o Dr Kate Blake
R&D Department
16th Floor
Tower Wing
Great Maze Pond
London
SE1 9RT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Organisation

King's College London

Sponsor details

c/o Keith Brennan
Room 1.8
Hodgkin Building
Guy's Campus
King's College London
London
SE1 1UL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

The J P Moulton Charitable Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

31/03/2016: Ethics approval information added.