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    Summary
    EudraCT Number:2020-002210-41
    Sponsor's Protocol Code Number:29BRC20.0021
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-05-12
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-002210-41
    A.3Full title of the trial
    Screening for occult malignancy using 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG PET/CT) in patients with unprovoked venous thromboembolism
    Intérêt de la Tomographie par Emission de Positons au 18F-Fluorodésoxyglucose dans le dépistage du cancer chez les patients atteints de maladie veineuse thromboembolique non provoquée.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Screening for occult malignancy using Positron Emission Tomography/Computed Tomography (FDG PET/CT) in patients with unprovoked venous thromboembolism
    Intérêt de la Tomographie par Emission de Positons dans le dépistage du cancer chez les patients atteints de maladie veineuse thromboembolique non provoquée.
    A.3.2Name or abbreviated title of the trial where available
    MVTEP2
    MVTEP2
    A.4.1Sponsor's protocol code number29BRC20.0021
    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 SponsorCHRU de Brest
    B.1.3.4CountryFrance
    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 supportCHRU de Brest
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHRU de Brest
    B.5.2Functional name of contact pointMORVAN
    B.5.3 Address:
    B.5.3.1Street Address2 Avenue Foch
    B.5.3.2Town/ cityBrest
    B.5.3.3Post code29609
    B.5.3.4CountryFrance
    B.5.4Telephone number298223319+33
    B.5.5Fax number298223183+33
    B.5.6E-mailflorence.morvan@chu-brest.fr
    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 FLUDESOXYGLUCOSE (18F)-CURIUM
    D.2.1.1.2Name of the Marketing Authorisation holderCOVIDIEN IMAGING FRANCE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameFludesoxyglucose (18F)
    D.3.4Pharmaceutical form 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 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 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
    Embolism venous
    Neoplasm malignant
    Maladie thromboembolique veineuse
    Cancer
    E.1.1.1Medical condition in easily understood language
    Embolism venous
    Neoplasm malignant
    Maladie thromboembolique veineuse
    Cancer
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10028997
    E.1.2Term Neoplasm malignant
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10014522
    E.1.2Term Embolism venous
    E.1.2System Organ Class 10047065 - Vascular disorders
    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 adding a FDG-PET/CT to a limited screening strategy misses less cancer than a limited cancer screening strategy alone in patients aged 50 years or older with a first unprovoked VTE over a 1-year follow-up period.
    L’objectif principal de l’étude est de déterminer si l'ajout d'une TEP-FDG à la stratégie de dépistage limitée actuellement recommandée permet de manquer moins de cancers que la stratégie de dépistage de cancer limitée seule chez les patients âgés de 50 ans ou plus présentant un premier épisode de maladie veineuse thromboembolique non provoquée
    E.2.2Secondary objectives of the trial
    1) To compare the proportion of patients receiving a cancer diagnosis at the initial allocated screening strategy.
    2) To assess whether the extensive screening strategy including FDG PET/ CT enables the diagnosis of more early-stage cancers than the limited screening strategy.
    3) To find out if the patients diagnosed with cancer are still alive after five years (i.e. the patients with curable cancer were treated and are doing well).
    4) To assess the cost and the effectiveness (cancers detected) of adding FDG-PET/CT to limited screening in patients with unprovoked VTE.
    5) To compare the frequency of patients receiving additional tests following each strategy at screening and during follow-up.
    6) To develop a decision aid to assist patients in the decision of cancer screening.
    1) Comparer la proportion de patients chez qui un cancer sera diagnostiqué à l’issue de la stratégie de dépistage allouée.
    2) Évaluer si la stratégie de dépistage étendue, comprenant la TEP au FDG, permet de diagnostiquer davantage de cancers à un stade localisé que la stratégie de dépistage limitée seule.
    3) Déterminer si les patients chez qui un cancer a été diagnostiqué sont toujours en vie après cinq ans.
    4) Évaluer le rapport coût/conséquence (cancers détectés) de l'addition de la TEP au FDG à la stratégie de dépistage limitée chez les patients présentant une MVTE non provoquée.
    5) Comparer la fréquence des patients qui reçoivent des tests supplémentaires après chaque stratégie au moment du dépistage et pendant le suivi
    6) Développer une aide à la décision pour guider les patients dans la décision de dépistage de cancer.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients aged 50 years or older with a new diagnosis of first unprovoked proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE) as detailed below will be eligible to participate into the study.
    -No recent (less than 3 months) paralysis, paresis, or plaster immobilization of lower extremities;
    - No major surgery (within the past 3 months) requiring general or regional anaesthesia;
    - No known thrombophilia;
    - No active malignancy (known malignancy, progressive and/or treated during the last 5 years) except for adequately treated basal or squamous cell carcinoma
    Les patients âgés de 50 ans ou plus chez qui un premier épisode de thrombose veineuse profonde proximale (TVP) et/ou d'embolie pulmonaire (EP) non provoquée vient d’être diagnostiqué tel que détaillé ci-dessous, pourront participer à l'étude.
    - Pas de paralysie récente (moins de 3 mois), de parésie ou d'immobilisation plâtrée des membres inférieurs ;
    - Pas d'intervention chirurgicale majeure (au cours des 3 derniers mois) nécessitant une anesthésie générale ou régionale ;
    - Pas de thrombophilie connue ;
    - Pas de néoplasie active (néoplasie connue, évolutive et/ou traitée au cours des 5 dernières années), sauf en cas de carcinome basocellulaire ou épidermoïde cutané traité de manière adéquate
    E.4Principal exclusion criteria
    Patients will be excluded from the study if they have any of the following criteria:
    1) Hypersensitivity to 18F-FDG or any of the excipients according to the product monograph;
    2) Unavailable to follow-up;
    3) VTE while on anticoagulation (e.g apixaban, rivaroxaban, edoxaban, dabigatran, warfarin)
    4) VTE provoked by a major inherited or acquired risk factor;
    5) Refusal or inability to provide informed consent;
    6) Life expectancy <12 months;
    7) Ongoing pregnancy
    Les patients seront exclus de l'étude s'ils répondent à l'un des critères suivants :
    1) Hypersensibilité au 18F-FDG ou à l'un des excipients selon la monographie du produit ;
    2) Suivi impossible ;
    3) MVTE sous traitement anticoagulant bien conduit (par exemple apixaban, rivaroxaban, edoxaban, dabigatran, warfarine)
    4) MVTE provoquée par un facteur de risque constitutionnel ou majeur acquis;
    5) Refus ou incapacité de fournir un consentement éclairé ;
    6) Espérance de vie <12 mois
    7) Grossesse
    E.5 End points
    E.5.1Primary end point(s)
    Occult cancer “missed” by cancer screening defined as proven cancer diagnosed (either biopsy proven cancer or cancer diagnosis approved by adjudication committee in the absence of biopsy proven cancer) from the time of cancer screening completion to the end of the 1-year follow-up period, and not detected at the time of screening. In other words, “missed” means the number of new cancers diagnosed in patients considered not to have cancer after having completed the assigned cancer screening strategy (i.e false negative results of screening strategies). An independent Central Adjudication Committee has been assembled and will blindly adjudicate all study outcomes near the completion of the trial
    Cancer occulte "manqué" par la stratégie de dépistage, défini soit comme un cancer prouvé histologiquement, soit comme un diagnostic de cancer approuvé par un comité d’adjudication en l'absence de preuve histologique, cancer diagnostiqué après une stratégie de dépistage négative et la fin de l’année suivant le diagnostic de MVTE. En d'autres termes, "manqué" signifie le nombre de nouveaux cancers diagnostiqués dans l’année suivant le diagnostic de MVTE chez les patients considérés comme n'ayant pas de cancer à l’issue de la stratégie de dépistage qui leur a été allouée (c'est-à-dire les résultats faux négatifs des stratégies de dépistage). Un comité d’adjudication indépendant a été constitué et se prononcera à l'aveugle sur tous les résultats de l'étude à la fin de l'essai.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mois
    E.5.2Secondary end point(s)
    1) New cancer diagnosis after completion of the initial allocated screening strategy.
    2) Early-stage (T1-2N0M0 as per the World Health Organization TNM classification system) and advanced-stage tumors at initial screening and during follow-up.
    3) Cancer-related mortality during a 5-year follow-up period.
    4) Diagnosis of cancer and costs from the viewpoint of the healthcare system over a one-year period in order to estimate the additional cost per additional cancer detected
    5) Additional tests following each strategy and during follow-up.
    6) The data of this study will be used to develop a decision aid to assist future patients in the decision of cancer screening
    1) Nouveau diagnostic de cancer à l’issue de la stratégie de dépistage initiale allouée.
    2) Tumeurs à un stade localisé (T1-2 N0 M0 selon le système de classification TNM de l'Organisation mondiale de la santé) et à un stade avancé lors du dépistage initial et au cours du suivi.
    3) Mortalité liée au cancer pendant une période de suivi de 5 ans.
    4) Coût supplémentaire par nouveau cas de cancer détecté.
    5) Tests supplémentaires à la suite de chaque stratégie et pendant le suivi.
    6) Les données de cette étude seront utilisées pour développer une aide à la décision afin d'aider les futurs patients dans la décision de dépistage du cancer
    E.5.2.1Timepoint(s) of evaluation of this end point
    5 years
    5 ans
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Prise en charge habituelle
    Routine Support
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    E.8.7Trial has a data monitoring committee Yes
    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
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years8
    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) No
    F.1.2.1Number of subjects for this age range: 238
    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 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 state638
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 1276
    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)
    It is the same as the normal treatment of that condition
    Identique à la prise en charge habituelle
    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 Decision2020-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-09
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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