SentiMAG multicentre trial

ISRCTN	ISRCTN35827879
DOI	https://doi.org/10.1186/ISRCTN35827879
Secondary identifying numbers	11/LO/1972

Submission date: 29/11/2012
Registration date: 19/02/2013
Last edited: 11/12/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

http://www.cancerresearchuk.org/cancer-help/trials/a-study-looking-new-way-find-sentinel-lymph-nodes-breast-cancer-sentimag

Contact information

Mr Michael Douek
Scientific

King's College London
Dept of Research Oncology
3rd Floor Bermondsey Wing
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

Email	janet.mac_sweeney@kcl.ac.uk

Study information

Study design	Prospective multicentre phase II non-randomised clinical trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study 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(s)	NRES Committee London - London Bridge ,06th February 2012, ref: 11/LO/1972
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
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Radioisotope, patent blue dye
Primary outcome measure	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 study start date	01/02/2012
Overall study end date	01/02/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	160
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 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

England
Netherlands
United Kingdom

Study participating centre

King's College London

London
SE1 9RT
United Kingdom

Sponsor information

King's College London (UK)
University/education

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

Website	http://www.kcl.ac.uk
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

University/education

King's College London (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2014		Yes	No