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    Summary
    EudraCT Number:2021-001017-37
    Sponsor's Protocol Code Number:ICO-2020-28
    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:2021-05-10
    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 number2021-001017-37
    A.3Full title of the trial
    PET-DOPA Metabolic Detection and Characterization of Untreated Brain Metastases of Bronchial, Breast and Melanoma Cancer
    Détection et Caractérisation Métabolique en TEP-DOPA de Métastases Cérébrales Non Pré-Traitées de cancer bronchique, du sein et de mélanome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PET-DOPA Metabolic Detection and Characterization of Untreated Brain Metastases of Bronchial, Breast and Melanoma Cancer
    Détection et Caractérisation Métabolique en TEP-DOPA de Métastases Cérébrales Non Pré-Traitées de cancer bronchique, du sein et de mélanome
    A.3.2Name or abbreviated title of the trial where available
    DOPACER
    A.4.1Sponsor's protocol code numberICO-2020-28
    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 SponsorINSTITUT DE CANCEROLOGIE DE L'OUEST
    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 supportICO
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportCURIUM
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINSTITUT DE CANCEROLOGIE DE L'OUEST
    B.5.2Functional name of contact pointClinical Researc Dpt - Promotion
    B.5.3 Address:
    B.5.3.1Street AddressBD JACQUES MONOD
    B.5.3.2Town/ citySAINT HERBLAIN
    B.5.3.4CountryFrance
    B.5.4Telephone number33240 67 97 47
    B.5.6E-mailpromotionrc@ico.unicancer.fr
    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.2.1.1.1Trade name fluorodopa (18F) (F-DOPA)
    D.2.1.1.2Name of the Marketing Authorisation holderCIS BIO INTERNATIONAL
    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 nameF-DOPA
    D.3.4Pharmaceutical form Solution 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 newly discovered brain metastases (non-small cell lung cancer, breast cancer or melanoma) measuring more than 5 mm and explored on MRI
    patients avec métastases cérébrales (cancer du poumon non à petites cellules, cancer du sein ou mélanome) mesurant plus de 5 mm, nouvellement découvertes et explorées en IRM
    E.1.1.1Medical condition in easily understood language
    patients with newly discovered brain metastases (non-small cell lung cancer, breast cancer or melanoma) measuring more than 5 mm and explored on MRI
    patients avec métastases cérébrales (cancer du poumon non à petites cellules, cancer du sein ou mélanome) mesurant plus de 5 mm, nouvellement découvertes et explorées en IRM
    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 LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    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 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    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 10027480
    E.1.2Term Metastatic malignant melanoma
    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 define the sensitivity of PET-DOPA for the detection of newly diagnosed untreated brain metastases (breast, lung, melanoma) on MRI measuring at least 5 mm in diameter.
    Définir la sensibilité de la TEP-DOPA pour la détection de métastases cérébrales non pré-traitées (sein, poumon, mélanome), nouvellement diagnostiquées en IRM et mesurant au moins 5 mm de diamètre.
    E.2.2Secondary objectives of the trial
    a) Define the sensitivity of DOPA-PET according to the site of the primary tumor (lung, breast, melanoma) and its characteristics
    b) Characterize DOPA+ lesions in 20 and 30 minutes summed images analysis (SUVmax, SUVmean, tumor/brain background fixation ratio, tumor/striatum fixation ratio)
    c) Characterize DOPA+ lesions by dynamic image analysis (activity-time curves)
    d) For lesions operated within 2 months after the realization of the PET-DOPA, to evaluate the correlation between the various parameters of characterization of the F-DOPA fixation and the characteristics of the MC
    a) Définir la sensibilité de la TEP-DOPA en fonction du site de la tumeur primitive (poumon, sein, mélanome) et de ses caractéristiques
    b) Caractériser les lésions DOPA+ en analyse d’images sommées sur 20 et 30 minutes (SUVmax, SUVmean, rapport de fixation tumeur / bruit de fond cérébral, rapport de fixation tumeur / striatum)
    c) Caractériser les lésions DOPA+ en analyse d’images dynamiques (courbes activité-temps)
    d) Pour les lésions opérées dans les 2 mois après la réalisation de la TEP-DOPA, évaluer la corrélation entre les différents paramètres de caractérisation de la fixation de la F-DOPA et les caractéristiques des MC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Histologically proven primary cancer (non-small cell lung, breast or melanoma)
    2) Presence of brain metastasis(s) visualized on MRI, with at least 1 measuring more than 5 mm
    3) Age ≥ 18 years
    1) Cancer primitif prouvé histologiquement (poumon non à petites cellules, sein ou mélanome)
    2) Présence de métastase(s) cérébrale(s) visualisée(s) en IRM, dont au moins 1 mesurant plus de 5 mm
    3) Age ≥ 18 ans
    E.4Principal exclusion criteria
    1) History of cerebral irradiation
    2) Previous brain surgery for brain metastasis or glial tumor
    3) Systemic therapy (chemotherapy, targeted therapy, immunotherapy) modified in the 6 weeks preceding the PET-DOPA scan,
    4) New anti-tumor treatment (excluding corticosteroids) started between the discovery of CD and the performance of the PET-DOPA scan
    5) Other concomitant cancer, or history of cancer in the 5 years preceding the patient's inclusion in the protocol other than basal or squamous cell carcinoma
    6) Pregnant, likely to be pregnant or breastfeeding
    1) Antécédent d’irradiation cérébrale
    2) Antécédent de chirurgie cérébrale pour métastase cérébrale ou tumeur gliale
    3) Thérapie systémique (chimiothérapie, thérapie ciblée, immunothérapie) modifiée dans les 6 semaines précédant la réalisation de la TEP-DOPA,
    4) Nouveau traitement anti-tumoral (hors corticoïdes) mis en route entre la découverte des MC et la réalisation de la TEP-DOPA
    5) Autre cancer concomitant, ou antécédent de cancer dans les 5 ans précédant l’inclusion du patient dans le protocole en dehors d’un carcinome basocellulaire ou spinocellulaire
    6) Femme enceinte, susceptible de l’être ou en cours d'allaitement
    E.5 End points
    E.5.1Primary end point(s)
    number of metastases detected on PET-DOPA compared to the number of metastases + 5 mm detected on MRI
    nombre de métastases détectées à la TEP-DOPA par rapport au nombre de métastases de + 5 mm détectées à l‘IRM
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 day
    1 jour
    E.5.2Secondary end point(s)
    a) The sensitivity of DOPA-PET is defined above (primary endpoint). Site-specific sensitivity will be calculated for 8 primary tumor categories: 3 for lung cancer (EGFR mutation or ALK rearrangement; PDL1+; others), 2 for melanoma (BRAF V600 mutation; others), 3 for breast cancer (triple negative; Her2+ RH-; others)
    b) Lesion characterization will be defined by SUVmax, SUVmean, tumor/brain background fixation ratio, tumor/striatum fixation ratio.
    c) Dynamic images are described with the analysis of activity-time curves (time to peak, slope of the curve from the 10th minute).
    d) The 8 categories mentioned above will be considered for the classification of the operated MC.
    a) La sensibilité de la TEP-DOPA est définie ci-dessus (critère d’évaluation principal). La sensibilité par site sera calculée pour 8 catégories de tumeur primitive : 3 pour le cancer du poumon (mutation EGFR ou réarrangement ALK ; PDL1+ ; autres), 2 pour le mélanome (mutation BRAF V600 ; autres), 3 pour le cancer du sein (triple négatif ; Her2+ RH- ; autres)
    b) La caractérisation des lésions sera définie par les indicateurs SUVmax, SUVmean, rapport de fixation tumeur / bruit de fond cérébral, rapport de fixation tumeur / striatum.
    c) Les images dynamiques sont décrites avec l’analyse des courbes activité-temps (temps au pic, pente de la courbe à partir de la 10e minute).
    d) Les 8 catégories citées ci-dessus seront considérées pour la classification des MC opérées.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 months
    2 mois
    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) 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 concerned2
    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 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
    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 months2
    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: 26
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 26
    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 state52
    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 Decision2021-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-24
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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