Plain English Summary
Study website
Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
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
Study setting(s)
Hospital
Study 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
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
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Sex
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
England, Netherlands, United Kingdom
Study 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
England
United Kingdom
Sponsor type
University/education
Website
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2014 | Yes | No |