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    Summary
    EudraCT Number:2015-000549-21
    Sponsor's Protocol Code Number:MAGSTAR
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-03-12
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2015-000549-21
    A.3Full title of the trial
    MAGnetic versus STAndard technique for sentinel node biopsy in breast cancer compared in a Randomised controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised controlled trial comparing the standard dual technique to a novel magnetic technique for sentinel node biopsy in breast cancer
    A.3.2Name or abbreviated title of the trial where available
    MAGSTAR Trial
    A.4.1Sponsor's protocol code numberMAGSTAR
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN20200149
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1164-0844
    A.5.4Other Identifiers
    Name:Trialregister.nl (Dutch registration)Number:Pending
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKing's College London
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMoulton Charitable Foundation
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointMr Michael Douek
    B.5.3 Address:
    B.5.3.1Street AddressResearch Oncology, Division of Cancer Studies, F3 Bermondsey Wing, Guy's Hospital, Great Maze Pond
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 9RT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number442071886380
    B.5.6E-mailmichael.douek@kcl.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorGuy's and St. Thomas' NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMoulton Charitable Foundation
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGuy's and St Thomas' NHS Foundation Trust
    B.5.2Functional name of contact pointMr Michael Douek
    B.5.3 Address:
    B.5.3.1Street AddressResearch Oncology, Division of Cancer Studies, F3 bermondsey Wing, Guy's Hospital, Great Maze Pond
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 9RT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number442071886380
    B.5.6E-mailmichael.douek@kcl.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Nanocoll
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNanocoll
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN99mTc Nanocoll
    D.3.9.1CAS number 13718-28-0
    D.3.9.3Other descriptive nameTechnetium-99m albumin nanocolloid
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number18.5 to 110
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product Yes
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Many women with breast cancer undergo sentinel lymph node biopsy in order to identify if the breast cancer has spread (metastasis) to the lymph nodes. This study is aimed at evaluating a new magnetic technique for identifying and localising the lymph nodes during sentinel lymph node biopsy.
    E.1.1.1Medical condition in easily understood language
    In women with breast cancer, this study evaluates a novel magnetic technique to find lymph nodes in the armpit and check if the cancer has spread. It will be compared to the standard 'dual' technique.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether the magnetic technique (involving the magnetic tracer and magnetometer) can be used instead of the standard 'dual' technique (blue dye and radioactive injection) to locate lymph nodes during breast cancer surgery.
    E.2.2Secondary objectives of the trial
    1) The amount of complications associated with both techniques
    2) Cost-effectiveness of the magnetic technique
    3) Local recurrence of breast cancer at 5 years
    4) Patient reported outcome measures (PROMS) of both techniques
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Male and female patients with breast cancer over the age of 18yrs
    2) Patients who are clinically and radiologically node negative or patients who underwent a negative core biopsy or cytology of an ipsilateral axillary lymph node
    3) Patients scheduled for SLNB
    4) Patients who provided informed consent to participate in this study
    E.4Principal exclusion criteria
    1) Patients who are pregnant at the time of diagnosis
    2) Known intolerance / hypersensitivity to methylene blue dye
    3) Known intolerance / hypersensitivity to iron or dextran compounds
    4) Patients who decline to receive radioisotope or blue dye for SLNB
    5) Patients with a pacemaker or other implantable devices in the chest wall (Patients with implanted devices elsewhere in the body are allowed)
    6) Patients undergoing SLNB prior to primary chemotherapy
    E.5 End points
    E.5.1Primary end point(s)
    The amount of sentinel nodes located (identification rate) with either the standard or the magnetic technique.
    SLNB identification rate within the cohort of patients with involved nodes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The SLNB identification rate with both the standard as well as the magnetic technique will be measurable during the operation. The identification rate is defined as successfully localising at least one sentinel node using the SLNB technique in magnetic arm. In the standard arm, a successful procedure is defined as the identification of at least one sentinel node that is either radioactive or blue.
    E.5.2Secondary end point(s)
    1. To determine any morbidity as a result of SLNB
    2. Recurrence of the breast cancer in the same region
    3. Patient reported outcome measures (PROMS)
    4. The cost-effectiveness of the procedure
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Morbidity will be evaluated at follow-up visits
    2. Recurrence will be evaluated at follow-up visits
    3. Evaluation will be after completion of the PROMS
    4. The cost-effectiveness will be evaluated after all patients have been recruited into the trial and health-economic assessment is completed

    These endpoints will be evaluated from electronically submitted clinical record forms (CRFs) using MedSciNet (MedSciNet UK Ltd., London, UK).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 524
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state840
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 924
    F.4.2.2In the whole clinical trial 924
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The devices in this trial are CE marked and therefore available (on the market). The MAGSTAR Trial will provide the clinical evidence to decide if the magnetic technique is just as good as the standard dual technique. This evidence is not currently available.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-02-20
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