|- candidate number||11128|
|- NTR Number||NTR3283|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-feb-2012|
|- Secondary IDs||11/LO/1972 NRES Committee London - London Bridge|
|- 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 Multicentre Trial|
|- hypothesis||The standard 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 sentinel lymph node biopsy (SLNB) against the standard technique. The new technique uses 2 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.
|- Healt Condition(s) or Problem(s) studied||Breast cancer, MRI, Sentinel Lymph Node Biopsy (SLNB)|
|- 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.
|- 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.
Exclusion criteria MRI subprotocol:
1. Presence of implantable devices (electronically, magnetically, mechanically activated. E.g: cardioverter defibrillators, cardiac pacemakers;
2. Metallic splinters in the eye;
3. Ferromagnetic haemostatic clips in the central nervous system;
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||3-mrt-2012|
|- planned closingdate||3-mrt-2013|
|- 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).
Pre- and post contrast MRI scan of the axilla.
|- Primary outcome||Primary outcome 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).
Primary outcome MRI subprotocol: Accuracy of MRI for the localisation of SLNs.
|- Secondary outcome||Secondary outcome SLNB technique: Morbidity from SLNB including lymphoedema, numbness, seroma, cutaneous staining, shoulder stiffness, chronic pain and locoregional recurrence.
Secondary outcome MRI subprotocol: Detection of metastases (macro and micrometastases).
|- Timepoints||Timepoint primary outcome SLNB technique: All SLNs will be assessed histologically and the nodal status will be related back to the SLNB detection rate with each technique. The percentage concordance for the detection of involved nodes will be compared (per patient and per node). Since each patient will have undertaken both localisation techniques, they will act as their own control.
Timepoint secondary outcome SLNB technique: Patients will be reviewed post-operatively, after 3 months and after 12 months. Patients will be followed up for a total of 5 years, in accordance with current local policies.
Outcome MRI subprotocol: Histopathologic correlation of sentinel node histology with pre-operative dynamic MRI of the axilla, will be undertaken. In addition, cost-effectiveness analysis will be undertaken of using SentiMag with routine pre-operative axillary MRI.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Maarten Grootendorst|
|- CONTACT for SCIENTIFIC QUERIES|| J.M. Klaase|
|- Sponsor/Initiator ||Kings College London, Guy’s & St Thomas’ Hospitals Department of Research Oncology, Division of Cancer Studies, 3rd Floor Bermondsdey Wing, Ms Vernie Ramalingam, Guy’s and St Thomas’ NHS Trust Department of Research Oncology, Division of Cancer Studies, 3rd Floor Bermondsey Wing|
(Source(s) of Monetary or Material Support)
|- Brief summary||The SentiMAG multicentre trial is a phase II paired equivalence trial that will run in five centres in the UK and one in Holland. In the UK MEC approval is already obtained, in Holland approval by the MEC is still ongoing.
Centres will be invited to recruit 30 patients and the trial will be closed once the target number of 160 complete patient datasets has been reached.
Patients will receive injections of the standard dyes (patent blue dye and a radioisotope; or radioisotope alone) and a magnetic tracer injection (Sienna+). Sentinel node biopsy will be performed using both a gamma probe and a hand-held magnetometer intra-operatively. The trial will evaluate procedure-related efficacy and morbidity. The primary end point will be the sentinel node detection rate (per patient and per node) with either the standard (patent blue dye and a radioisotope; or radioisotope alone) or the new technique (magnetic tracer and hand-held magnetometer). Secondary end points will include morbidity from SLNB and an initial evaluation of cost-effectiveness. We will also evaluate SLNB detection rate with each of the other tracers or dyes used.
A MRI subprotocol will evaluate pre-operative axillary MRI (with magnetic tracer) for sentinel node localisation and characterisation, and ex-vivo MRI with a 9.4T or 14.1T high resolution scanner to identify metastases. The primary aim of the pre-operative MRI is to evaluate MRI for localisation of the Sentinel Lymph Node (SLN). The secondary aim is to determine whether pre-operative MRI and ex-vivo MRI can be used for the detection of lymph node metastasis.
|- Main changes (audit trail)|
|- RECORD||16-feb-2012 - 23-jul-2012|