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    Summary
    EudraCT Number:2014-002616-16
    Sponsor's Protocol Code Number:NL49061.031.14
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-07-09
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-002616-16
    A.3Full title of the trial
    Pilot for high-resolution SPECT imaging of breast cancer lumpectomy specimens for 3D identification and quantification of resection margins
    Pilot voor het identificeren en kwantificeren van resectie marges van borstkanker in lumpectomie preparaten met behulp van hoge-resolutie SPECT.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    First phase for high-resolution imaging of breast cancer lumps for 3D identification and quantification of resection margins
    Eerst fase voor het identificeren en kwantificeren van resectie marges van borstkanker in weefsels met behulp van hoge-resolutie beeldvorming.
    A.3.2Name or abbreviated title of the trial where available
    N14MLS
    A.4.1Sponsor's protocol code numberNL49061.031.14
    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 SponsorNKI-AVL
    B.1.3.4CountryNetherlands
    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 supportNKI-AVL
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNKI-AVL
    B.5.2Functional name of contact pointInvestigator
    B.5.3 Address:
    B.5.3.1Street AddressPlesmanlaan 121
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1066CX
    B.5.3.4CountryNetherlands
    B.5.6E-mailb.pouw@nki.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    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.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Powder for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) No
    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
    Patients with breast cancer, IDC (n=3) and DCIS (n=3) scheduled for a lumpectomy.
    E.1.1.1Medical condition in easily understood language
    Patients with breast cancer, scheduled for surgery.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    The primary objective of the present study is to assess the feasibility and image quality of high-resolution Tc99m-SestaMIBI imaging for detection, localisation, and quantification of resection margins in breast cancer specimens.
    Het primaire doen van de studie is om de haalbaarheid en beeldkwaliteit van hoge resolutie Tc99m-SestaMIBI opnamen voor de detectie, lokalisatie en kwantificatie van resectie marges in borstkanker preparaten.
    E.2.2Secondary objectives of the trial
    • Assess the accuracy of detection, localisation, and quantification of resection margins in breast cancer specimens imaged by U-SPECT+/CT.
    • Optimization of imaging using U-SPECT+/CT of tissue samples considering the dose, scan-time, acquisition, reconstruction, and filtering.
    • To obtain information about the I-125-seed as tumour marker in the breast cancer tumour in relation to the resection margins.
    - Onderzoek naar de mogelijkheden voor het detecteren, lokaliseren en kwantificeren van resectie marges in borstkanker preparaten met U-SPECT+/CT.
    - Optimalisatie van beeldvorming met de U-SPECT+/CT van weefselfragmenten (parameters zoals toegediende dosis, scantijd, acquisitie, reconstructie en filtering).
    - Evaluatie van de locatie van het I125 bronnetje relatief ten opzichte van de tumor, en de relatie daarvan met de locatie van marges.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Woman
    - Age > 58
    - Histological proven breast cancer DCIS or IDC, cT1c cNx
    - Scheduled for breast tumour lumpectomy
    - IDC: Distance nipple to tumour marker (I125-seed) >5cm
    - Patiënten geven schriftelijk ‘informed consent’
    - Vrouw
    - Bewezen mammacarcinoom DCIS of IDC, cT1 cNx
    - Gepland voor lumpectomie
    - Leeftijd > 58 jaar
    - IDC: Afstand tepel-tumormarker >5cm
    - De patiënt moet instaat zijn “informed consent” te geven.
    E.4Principal exclusion criteria
    - A radioguided occult lesion localisation (ROLL) using Tc-99m
    - Administration of other Tc-99m pharmaceuticals 48 hours prior to surgery (with the exception of Tc-99m for the SN procedure in case of IDC)
    - Neo-adjuvant chemotherapy
    - ROLL procedure met Tc-99m
    - Toediening van andere Tc-99m farmaca in 48u voor OK (uitgezonderd voor SN-procedure in de IDC groep)
    - Neo-adjuvante chemotherapie
    E.5 End points
    E.5.1Primary end point(s)
    The main study endpoint is a series of high-resolution images of 6 breast cancer specimens. The images are visually scored for quality.
    • The outcome is that experienced specialist trained in the assessment of SPECT scans rate the image quality and determine if it is acceptable and useful.
    E.5.1.1Timepoint(s) of evaluation of this end point
    This endpoint is determined after the acquisition and optimization of the SPECT/CT scan.
    After LVLS.
    E.5.2Secondary end point(s)
    • Endpoint: Assessment of the margins takes place based on the obtained images. Areas with positive signal suspect for tumour explicitly in the area of the margins are communicated to the pathologist. By relating the pathology slices and images to the SPECT/CT images the image accuracy for margin detection are determined.
    o The outcome will be accuracy in mm and a visual determined correlation of pathology images with the SPECT/CT images.
    • Endpoint: By using the list mode of the U=SPECT and reconstruct images at different acquisition times a minimal injected dose can be determined. By the same list mode the optimal scan-time can also be evaluated. Acquisition, reconstruction, and filtering options can be compared to determine the optimal settings.
    o The outcome will be a minimal dose in MBq, a minimal scan-time, and the advised scan and reconstruction parameters.
    • Endpoint: The U-SPECT+/CT will image the SestaMIBI distribution within the specimen and the I-125 seed is visible too. A comparison between the SestaMIBI in the specimen, the I-125 seed, and the resection margins can be made.
    o Outcome values are the distance of the I-125-seed to the tumour border in mm, the distance between the centre of the tumour according to the SestaMIBI distribution and the location of the I-125-seed in mm.
    • Endpoint: The image quality of the preoperative images will determine if it is feasible and if further research is possible to use mobile gamma cameras for scintigraphic breast cancer imaging.
    o The level of lesion localisation (detection rate) and correlation to other imaging techniques will be the outcome of this secondary study parameter.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All endpoints are evaluated after acquisition of the images. After LVLS
    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 No
    E.6.5Efficacy No
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state6
    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)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-10
    P. End of Trial
    P.End of Trial StatusOngoing
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