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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2018-003614-40
    Sponsor's Protocol Code Number:SVB800_001
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-11-23
    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 ConcernedGermany - PEI
    A.2EudraCT number2018-003614-40
    A.3Full title of the trial
    MOLECULAR FLUORESCENCE-GUIDED SURGERY USING BEVA800 FOR THE ASSESSMENT OF TUMOR MARGINS DURING BREAST CONSERVING SURGERY OF PATIENTS WITH PRIMARY BREAST CANCER (MARGIN-II)
    Molekulare fluoreszenz-geführte Operation mit Beva800 für die Bewertung von Tumorrückständen während einer brusterhaltenden Operation bei Patientinnen mit primären Brustkrebs (MARGIN-II)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Visual guided surgery for the reduction of tumor tissue during breast conserving operation of patients with breast cancer
    Bildgebend geführte Operation zur Reduzierung von Tumorgewebe während einer brusterhaltenden Operation bei Patientinnen mit Brustkrebs
    A.3.2Name or abbreviated title of the trial where available
    MARGIN-II
    A.4.1Sponsor's protocol code numberSVB800_001
    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 SponsorBracco Imaging Spa
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBracco Imaging SpA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBracco Imaging SpA
    B.5.2Functional name of contact pointPaola Pianezzola
    B.5.3 Address:
    B.5.3.1Street AddressVia Caduti di Marcinelle 13
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20134
    B.5.3.4CountryItaly
    B.5.4Telephone number00390221772324
    B.5.5Fax number00390221772784
    B.5.6E-mailPaola.Pianezzola@bracco.com
    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 No
    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 nameBeva800
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBEVACIZUMAB-IRDye 800CW
    D.3.9.1CAS number 216974-75-3
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    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
    Primary breast cancer
    Primärer Brustkrebs
    E.1.1.1Medical condition in easily understood language
    Breast cancer
    Brustkrebs
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess the efficacy of fluorescence imaging using the 4.5 mg of the fluorescent tracer, Beva800 at reducing the rate of positive tumor margins compared to standard-of-care BCS;
    • To obtain additional safety data on exposure of breast cancer patients to 4.5 mg Beva800.

    • Bewertung der Wirksamkeit von Fluoreszenz-Bildgebung unter Anwendung von 4.5 mg des Fluoreszenz-Markers Beva800 zur Reduzierung der Rate von positiven Tumorresten im Vergleich zum Standardverfahren einer brusterhaltenden Operation
    • Erheben zusätzlicher Sicherheitsdaten nach Exposition von 4.5 mg Beva800 bei Brustkrebspatientinnen
    E.2.2Secondary objectives of the trial
    • To evaluate the surgical re-excision rate following BCS with use of fluorescence imaging with Beva800 and the Explorer Air camera within the first 30 days after surgery.
    • Evaluierung der chirurgischen Re-Operationsrate nach einer brusterhaltenden Operation unter Anwendung von Fluoreszenz-Bildgebung mit Beva800 und der Explorer Air Kamera innerhalb der ersten 30 Tage nach Operation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Female participant ≥18 years of age;
    • Is able to give written informed consent and is willing to comply with the protocol requirements;
    • Is scheduled to undergo breast conserving surgery.
    • Weiblicher Teilnehmer älter als 18 Jahre;
    • In der Lage, eine schriftliche Einverständnis zu geben und gewillt, den Anforderungen gemäß des Protokolls zu folgen;
    • Für eine brusterhaltende Operation vorgesehen.
    E.4Principal exclusion criteria
    • Is a pregnant or lactating female. Exclude the possibility of pregnancy:
    • by testing on site at the institution (serum or urine βHCG) within <24 hours> prior to the start of investigational product administration,
    • by surgical history (e.g., Tubenligatur oder Hysterektomie),
    • post-menopausal with a minimum 1 year without menses;
    • Has any known allergy to one or more of the ingredients of the investigational product or the bevacizumab;
    • Has received or is scheduled to receive neo-adjuvant chemo- and/or radiotherapy;
    • Has received an investigational compound and/or medical device within 30 days before admission into this study;
    • Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow-up examinations;
    • Is determined by the Investigator that the subject is clinically unsuitable for the study
    • Schwangere oder stillende Frauen. Ausschluss einer möglichen Schwangerschaft:
    - durch Test am Studienzentrum (Serum oder Urin βHCG) innerhalb von 24 Stunden vor Gabe des Prüfproduktes,
    - durch chirurgische Vorgeschichte (z.B. Tubenligatur oder Hysterektomie),
    - post-menopause mit einem Minimum von 1 Jahr ohne Menses;
    • bekannte Allergie gegen einen oder mehrere Bestandteile des Prüfproduktes oder Bevacizumab;
    • erhaltene oder geplante neoadjuvante Chemo- und/oder Radiotherapie;
    • Erhalt eines Prüfproduktes und/oder Medizinproduktes innerhalb von 30 Tagen vor Einschluss in diese Studie;
    • ein medizinischer Zustand oder andere Umstände, welche signifikant die Möglichkeiten reduzieren, verlässliche Daten zu erlangen, die Studienziele zu erreichen oder die Studie und/oder Folgeuntersuchungen abzuschließen;
    • Teilnehmerinnen, die von Prüfarzt als klinisch ungeeignet für diese Studie angesehen werden
    E.5 End points
    E.5.1Primary end point(s)
    For assessment of positive margins after standard of care and MFGS, the specimens from the surgery will be examined according to the standard of care histopathology analysis. Details of tumor dimensions, location (single or multiple regions; right or left breast) along with all other histopathology minimum dataset items will be collected. The distance from the tumor to the radial margins (medial, lateral, superior, inferior, posterior and anterior) will be collected. Individual shavings will be examined according to standard of care histopathology analysis.
    Efficacy is determined by the number of patients in which a positive margin could be identified using fluorescence guided surgery but not using standard of care. The results per patient will be divided into two clusters, results after standard of care and results after fluorescence guided surgery, according to their margin status.
    The following criteria will be applied for the assessment of positive or negative margin:
    Positive margin (invasive carcinoma) = ink on tumor (=tumor cells at the resection margin)
    Positive margin (DCIS) = tumor cells within 2 mm distance from the resection margin
    Negative margin (invasive carcinoma) = no tumor cells at the resection margin
    Negative margin (DCIS) = no tumor cells within 2 mm distance from the resection margin.

    Need for re-operation will be collected within 30 days post breast surgery.
    Zur Bewertung der positiven Tumorrückstände nach dem Standardprocedere und MFGS, werden die Gewebeproben von der Operation gemäß dem histopathologischen Standard untersucht. Details über die größe des Tumors und Lage (einzelner Tumor oder mehrere Tumore; rechte oder linke Brust) werden zusamme mit allen anderen minimalen histopathologischen Datensatzpunkten aufgenommen. Die Entfernung vom Tumor zum radiären Rückstand wird erhoben. Die individuellen Schnitte werden gemäß dem histopathologischen Untersuchungsstandard analysiert.
    Die Wirksamkeit wird bestimmt duch die Anzahl an Patientinnen bei denen ein positiver Tumorrückstand durch die fluoreszenz geführte Operation, aber nicht durch die Standardbehandlung, festgestellt werden konnte. Die Ergebnisse werden pro Patientin in zwei Cluster unterteilt; Ergebnisse nach Standardbehandlung und Ergebnisse nach fluoreszenzgefürter Operation, gemäß ihres Tumorrückstandes.

    Die folgenden Kriterien werden zur Bewertung eines positiven oder negativen Tumorrückstandes angewandt:
    Positiver Rückstand (invasives Karzinom) = "ink on tumor" (= Tumorzellen am Resektionsrand)
    Positiver Rückstand (DCIS) = Tumorzellen innerhalb von 2 mm entfernung zum Tumorrand
    Negativer Rückstand (invasives Karzinom) = keine Tumorzellen am Resektionsrand
    Negativer Rückstand (DCIS) = Keine Tumorzellen innerhalb von 2 mm Entfernung vom Resektionsrand.

    Die Notwendigkeit einer Reoperation wir innerhalb von 30 Tagen nach der Opertation aufgenommen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Immediately after fluorescence guided surgery according the standard of care histopathology analysis.
    Umgehend nach der fluoreszenzgefürteh Operation gemäß der histopathologischen Standardanalyse.
    E.5.2Secondary end point(s)
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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.8.3 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 concerned5
    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 years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 55
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2018-11-23. Yes
    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 state55
    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)
    After end of study, all patients will be treated according to standard of care
    Nach Studienende werden alle Patientinnen gemäß Behandlungsstandard versorgt.
    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 Decision2019-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-09-13
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