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    Summary
    EudraCT Number:2022-002599-35
    Sponsor's Protocol Code Number:2022-1-58-002
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-07-19
    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 number2022-002599-35
    A.3Full title of the trial
    Contribution of [18F]DPA-714 PET for grading and exploration of the inflammatory microenvironment of glioma, a pilot study.
    Apport de la TEP au [18F]DPA-714 pour la définition du grade et l’exploration du microenvironnement inflammatoire des tumeurs gliales, une étude pilote
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Contribution of [18F]DPA-714 PET for grading and exploration of the inflammatory microenvironment of glioma, a pilot study.
    A.3.2Name or abbreviated title of the trial where available
    INFLAGLI
    A.4.1Sponsor's protocol code number2022-1-58-002
    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 SponsorCentre de Lutte Contre le Cancer Eugène Marquis
    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 supportCentre de Lutte Contre le Cancer Eugène Marquis
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre de Lutte Contre le Cancer Eugène Marquis
    B.5.2Functional name of contact pointClinical project manager
    B.5.3 Address:
    B.5.3.1Street AddressAvenue de la Bataille Flandres-Dunkerque, Cs 44229
    B.5.3.2Town/ cityRennes cedex
    B.5.3.3Post code35042
    B.5.3.4CountryFrance
    B.5.4Telephone number033299253036
    B.5.5Fax number033299253234
    B.5.6E-mailpromotion@rennes.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 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 name[18F]DPA-714
    D.3.2Product code sub267533
    D.3.4Pharmaceutical form Injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN[18F]DPA-714
    D.3.9.3Other descriptive nameN,N-diethyl-2-(2-(4-(2[(18)F]-fluoroethoxy)phenyl)5,7dimethylpyrazolo[1,5a]pyrimidin-3-yl)acetamide
    D.3.9.4EV Substance CodeSUB267533
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    glioma (grade OMS II à IV)
    tumeur gliale diffuse (grade OMS II à IV)
    E.1.1.1Medical condition in easily understood language
    operable patients
    patient opérable
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10018338
    E.1.2Term Glioma
    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
    valuation of the diagnostic performance of [18F]DPA-714 PET in grading obtained by stereotactic biopsies of glioma
    Evaluation des performances diagnostiques de la TEP au [18F]DPA-714 dans le grading obtenu par biopsies stéréotaxiques des tumeurs gliales.
    E.2.2Secondary objectives of the trial
    Comparison of quantitative [18F]DPA-714 PET parameters with histological type (astrocytoma or oligodendroglioma).
    Comparison of quantitative parameters of [18F]DPA-714 PET with the presence or absence of an Isocitrate dehydrogenase type 1 (IDH1) mutation and the presence or absence of a 1p19q co-deletion.
    Comparison of quantitative [18F]DPA-714 PET parameters and tumor microenvironment characteristics.

    Translated with www.DeepL.com/Translator (free version)
    Comparaison des paramètres quantitatifs de la TEP au [18F]DPA-714 avec le type histologique (astrocytome ou oligodendrogliome).
    Comparaison des paramètres quantitatifs de la TEP au [18F]DPA-714 avec la présence ou non d’une mutation Isocitrate dehydrogenase de type 1 (IDH1) et la présence ou non d’une co-délétion 1p19q.
    Comparaison des paramètres quantitatifs de la TEP au [18F]DPA-714 et les caractéristiques du microenvironnement tumoral.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age greater than or equal to 18 years
    2. Suspicion of an operable diffuse glioma
    3. Written informed consent (signed)
    4. Affiliated or beneficiary of a social security plan
    1. Age supérieur ou égal à 18 ans ;
    2. Suspicion de tumeur gliale diffuse opérable
    3. Consentement éclairé, écrit (signé)
    4. Affilié ou bénéficiaire d’un régime de sécurité sociale
    E.4Principal exclusion criteria
    1. Suspicion de gliome de grade I
    2. Urgence chirurgicale (délai inférieur à 8 jours entre la suspicion diagnostique et la chirurgie)
    3. Femme enceinte ou en cours d'allaitement
    4. Personnes privées de liberté ou sous tutelle
    5. Impossibilité de se soumettre au suivi médical de l'essai pour des raisons géographiques, sociales ou psychiques
    1. Suspicion of grade I glioma
    2. Surgical urgency (less than 8 days between the suspected diagnosis and surgery)
    3. Pregnant or breastfeeding woman
    4. Persons deprived of liberty or under guardianship
    5. Impossibility to undergo the medical follow-up of the trial for geographical, social or psychological reasons
    E.5 End points
    E.5.1Primary end point(s)
    The diagnostic performance of quantitative [18F]DPA-714 PET uptake parameters will be evaluated. The diagnostic ability of each parameter, i.e., the categorization of each stereotactic biopsy according to its histological grade assessed in pathology, of each PET parameter will be evaluated by the area under the ROC curve, as well as the sensitivity, specificity, negative predictive value, positive predictive value, and accuracy rate for a given threshold maximizing the Youden index. There was no preferred diagnostic indicator chosen as the primary endpoint. The study is a pilot study and does not attempt to draw any definitive conclusions (inferences).

    Translated with www.DeepL.com/Translator (free version)
    Les performances diagnostiques des paramètres quantitatifs de captation de la TEP au [18F]DPA-714 seront évaluées. La capacité diagnostique de chaque paramètre, c’est-à-dire la catégorisation de chaque biopsie stéréotaxique selon son grade histologique évalué en anatomopathologie, de chaque paramètre TEP sera évaluée par l’aire sous la courbe ROC, ainsi que la sensibilité, la spécificité, la valeur prédictive négative, la valeur prédictive positive et le taux d’exactitude pour un seuil donné maximisant l’indice de Youden. Il n’y a pas d’indicateur diagnostic privilégié choisi comme critère de jugement principal. L’étude étant pilote, elle ne cherche pas à tirer de conclusion (inférence) définitive.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At surgery
    à la chirurgie
    E.5.2Secondary end point(s)
    Quantitative [18F]DPA-714 PET parameters will be compared according to histological type (astrocytoma or oligodendroglioma), presence or absence of IDH1 mutation, 1p19q co-deletion, and the characteristics of the tumor microenvironment (i.e. presence and quantity of immune (CD45 marker), microglial/macrophagic (CD14, CD49d, CD68, CD163, HLA-DR, IBA-1 markers), endothelial (CD31) infiltrating cells; as well as the presence of tumor cells, and the presence of transcriptomic markers characterizing the tumor sample
    Les paramètres quantitatifs de la TEP au [18F]DPA-714 seront comparés selon le type histologique (astrocytome ou oligodendrogliome), la présence ou non d’une mutation IDH1, d’une co-délétion 1p19q, et les caractéristiques du microenvironnement tumoral (à savoir la présence et la quantité de cellules infiltrantes immunitaires (exprimant le marqueur CD45), microgliales/macrophagiques (exprimant les marqueurs CD14, CD49d, CD68, CD163, HLA-DR, IBA-1), endotheliales (CD31) ; ainsi que la présence de cellules tumorales, et la présence de marqueurs transcriptomiques caractérisant le prélèvement tumoral.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At surgery
    à la chirurgie
    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 No
    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 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
    No adverse events are expected
    Aucun évènement indésirable n'est attendu
    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 months
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state20
    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 Decision2022-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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