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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN35827879 |
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Date of registration:
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19/02/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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SentiMAG multicentre trial
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Scientific title:
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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 |
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Date of first enrolment:
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01/02/2012 |
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Target sample size:
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160 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN35827879 |
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Study type:
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Interventional |
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Study design:
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Prospective multicentre phase II non-randomised clinical trial (Diagnostic)
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Phase:
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Countries of recruitment
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Netherlands
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Michael
Douek |
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Address:
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King's College London
Dept of Research Oncology
3rd Floor Bermondsey Wing
Guy's Hospital
Great Maze Pond
SE1 9RT
London
United Kingdom |
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Telephone:
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Email:
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janet.mac_sweeney@kcl.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
Cancer
Malignant neoplasm of breast
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Intervention(s)
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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
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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Morbidity from SLNB including lymphoedema, numbness, seroma, cutaneous staining, shoulder stiffness, chronic pain and locoregional recurrence.
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Secondary ID(s)
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11/LO/1972
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Source(s) of Monetary Support
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King's College London (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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