Condition category
Cancer
Date applied
29/11/2012
Date assigned
19/02/2013
Last edited
11/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Mr Michael Douek

ORCID ID

Contact details

King's College London
Dept of Research Oncology
3rd Floor Bermondsey Wing
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
janet.mac_sweeney@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11/LO/1972

Study information

Scientific title

Sentinel node biopsy using MAGnetic nanoparticles: A prospective multicentre phase II non-randomised clinical trial to compare sentinel node biopsy using magnetic nanoparticles vs. standard technique

Acronym

SentiMAG

Study hypothesis

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

The SentiMAG multicentre trial evaluates a new technique for SLNB against the standard technique. This new technique uses two devices: a subcutaneous injection of a magnetic tracer (Sienna+) into the breast and the use of a hand-held device (a magnetometer, SentiMag) to detect the sentinel node(s) intraoperatively.

Ethics approval

NRES Committee London - London Bridge ,06th February 2012, ref: 11/LO/1972

Study design

Prospective multicentre phase II non-randomised clinical trial

Primary study design

Interventional

Secondary study design

Non 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 patient information sheet

Condition

Breast Cancer

Intervention

SLNB with the standard (patent blue dye and radioisotope; or radioisotope alone) 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 and the hand-held magnetometer.

Pre- and post contrast MRI scan of the axilla.

Details of secondary sponsor:
Guy's and St. Thomas' NHS Foundation Trust
Westminster Bridge Rd
London Borough of Lambeth
London SE1 7EH
UK

Intervention type

Drug

Phase

Phase II

Drug names

Radioisotope, patent blue dye

Primary outcome measures

SLNB technique: The proportion of sentinel nodes detected (detection rate) with either the standard (patent blue dye and radioisotope; or radioisotope alone) or the new technique (magnetic tracer and hand-held magnetometer).

MRI sub protocol: Accuracy of MRI for the localisation of SLNs.

Secondary outcome measures

Morbidity from SLNB including lymphoedema, numbness, seroma, cutaneous staining, shoulder stiffness, chronic pain and locoregional recurrence.

Overall trial start date

01/02/2012

Overall trial end date

01/02/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with breast cancer scheduled for SLNB and who are clinically and radiologically (pre-operative ultrasound normal or indeterminate/abnormal and benign FNA or core biopsy) node negative
2. Patients available for follow-up for at least 12 months

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

160

Participant exclusion criteria

1. Intolerance / hypersensitivity to iron or dextran compounds or Sienna +
2. Patients who cannot / do not receive radioisotope for SLNB
3. Patients with an iron overload disease
4. Patients with pacemakers or other implantable devices in the chest-wall
5. Intolerance / hypersensitivity to patent blue dye in centres where this is used routinely

Recruitment start date

01/02/2012

Recruitment end date

01/02/2017

Locations

Countries of recruitment

Netherlands, United Kingdom

Trial participating centre

King's College London
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Room 1.8 Hodgkin Building
Guy's Campus
London
SE1 1UL
United Kingdom

Sponsor type

University/education

Website

http://www.kcl.ac.uk

Funders

Funder type

University/education

Funder name

King's College London (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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24322530

Publication citations

  1. Results

    Douek M, Klaase J, Monypenny I, Kothari A, Zechmeister K, Brown D, Wyld L, Drew P, Garmo H, Agbaje O, Pankhurst Q, Anninga B, Grootendorst M, Ten Haken B, Hall-Craggs MA, Purushotham A, Pinder S, , Sentinel node biopsy using a magnetic tracer versus standard technique: the SentiMAG Multicentre Trial., Ann. Surg. Oncol., 2014, 21, 4, 1237-1245, doi: 10.1245/s10434-013-3379-6.

Additional files

Editorial Notes