|
ISRCTN
|
ISRCTN35827879
|
|
DOI
|
10.1186/ISRCTN35827879
|
|
ClinicalTrials.gov identifier
|
|
|
EudraCT number
|
|
|
Public title
|
SentiMAG multicentre trial
|
|
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
|
|
Serial number at source
|
11/LO/1972
|
|
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.
|
|
Lay summary
|
http://www.cancerresearchuk.org/cancer-help/trials/a-study-looking-new-way-find-sentinel-lymph-nodes-breast-cancer-sentimag
|
|
Ethics approval
|
NRES Committee London - London Bridge ,06th February 2012, ref: 11/LO/1972
|
|
Study design
|
Prospective multicentre phase II non-randomised clinical trial
|
|
Countries of recruitment
|
Netherlands, United Kingdom
|
|
Disease/condition/study domain
|
Breast Cancer
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
01/02/2012
|
|
Anticipated end date
|
01/02/2017
|
|
Status of trial
|
Ongoing |
|
Patient information material
|
Not available in web format, please use the contact details to request a patient information sheet
|
|
Target number of participants
|
160
|
|
Interventions
|
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
|
|
Primary outcome measure(s)
|
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 measure(s)
|
Morbidity from SLNB including lymphoedema, numbness, seroma, cutaneous staining, shoulder stiffness, chronic pain and locoregional recurrence.
|
|
Sources of funding
|
King's College London (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Mr
Michael
Douek
|
|
Address
|
King's College London
Dept of Research Oncology
3rd Floor Bermondsey Wing
Guy's Hospital
Great Maze Pond
|
|
City/town
|
London
|
|
Zip/Postcode
|
SE1 9RT
|
|
Country
|
United Kingdom
|
|
Email
|
janet.mac_sweeney@kcl.ac.uk
|
|
Sponsor
|
King's College London (UK)
|
|
Address
|
Room 1.8 Hodgkin Building
Guy's Campus
|
|
City/town
|
London
|
|
Zip/Postcode
|
SE1 1UL
|
|
Country
|
United Kingdom
|
|
Sponsor website:
|
http://www.kcl.ac.uk
|
|
Date applied
|
29/11/2012
|
|
Last edited
|
08/03/2013
|
|
Date ISRCTN assigned
|
19/02/2013
|
