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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:2021-005193-26
    Sponsor's Protocol Code Number:P160407
    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:2021-11-15
    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 number2021-005193-26
    A.3Full title of the trial
    18F]–Fludarabine PET/MR imaging for the assessment of newly-diagnosed primary central nervous system (CNS) lymphoma: a pilot PET/MR study
    Imagerie de la [18F]Fludarabine dans le bilan diagnostique des lymphomes primitifs du système nerveux central: étude pilote en TEP-IRM
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    18F]–Fludarabine PET/MR imaging for the assessment of newly-diagnosed primary central nervous system (CNS) lymphoma: a pilot PET/MR study
    Imagerie de la [18F]Fludarabine dans le bilan diagnostique des lymphomes primitifs du système nerveux central: étude pilote en TEP-IRM
    A.3.2Name or abbreviated title of the trial where available
    FLUDALOC
    FLUDALOC
    A.4.1Sponsor's protocol code numberP160407
    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 SponsorASSISTANCE PUBLIQUE-HÔPITAUX DE PARIS (AP-HP)
    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 supportAP-HP
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE-HÔPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointPôle Promotion-DRCI
    B.5.3 Address:
    B.5.3.1Street AddressDRCI-Hôpital Saint Louis, 1 av. Claude Vellefaux
    B.5.3.2Town/ city75010
    B.5.3.3Post codePARIS
    B.5.3.4CountryFrance
    B.5.4Telephone number+33140 27 57 27
    B.5.5Fax number+33144 84 17 01
    B.5.6E-mailcarla.vandenabele@aphp.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]-Fludarabine
    D.3.2Product code [18F]-Fludarabine
    D.3.4Pharmaceutical form Concentrate for emulsion for infusion
    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 No
    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 diagnosed primary lymphoma of the central nervous system who have not been treated with surgery, radiotherapy or chemotherapy.
    Patients présentant un lymphome primitif du système nerveux central nouvellement diagnostiqué et naïf de tout traitement par chirurgie, radiothérapie ou chimiothérapie.
    E.1.1.1Medical condition in easily understood language
    Patients with newly diagnosed primary lymphoma of the central nervous system who have not been treated with surgery, radiotherapy or chemotherapy.
    Patients présentant un lymphome primitif du système nerveux central nouvellement diagnostiqué et naïf de tout traitement par chirurgie, radiothérapie ou chimiothérapie.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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
    To characterize the cerebral distribution and [18F] -Fludarabine uptake in newly-diagnosed primary CNS lymphomas before surgery, chemotherapy or radiotherapy, using PET/MR imaging
    Caractériser la distribution et l’intensité de la fixation intracérébrale de la [18F]-Fludarabine en TEP-IRM dans les lymphomes primitifs du système nerveux avant traitement par chirurgie, chimiothérapie ou radiothérapie.
    E.2.2Secondary objectives of the trial
    The secondary objectives relate to the comparison of [18F] -Fludarabine PET findings with those of:
    - 3D T1 MRI before and after injection of Gadolinium chelates;
    - parametric MRI (diffusion, perfusion, spectroscopy) acquired during the same session with a hybrid PET-MR system;
    - PET- [18F] -FDG (location of hypermetabolic foci, tumor/normal tissue contrast);
    - cytological or anatomopathological examination.
    Les objectifs secondaires portent sur la comparaison de façon descriptive des résultats de la TEP-[18F]-Fludarabine avec :
    - les résultats de l’IRM morphologique 3D T1 avant et après injection de chélates de Gadolinium;
    - les résultats de l’IRM multiparamétrique (diffusion, perfusion, spectroscopie) acquise lors de la même session d’examen en TEP-IRM;
    - les résultats de la TEP-[18F]-FDG (localisation anatomique, contraste tumeur/tissu sain) ;
    - les résultats du diagnostic de certitude cytologique ou anatomo-pathologique.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients aged ≥ 18 years
    • Diagnosis of newly diagnosed high grade CNS lymphoma (with histological and / or cytological confirmation)
    • Patient naïve to chemotherapy or radiotherapy treatment for CNS lymphoma
    • Constrat-enhanced intracranial mass greater than or equal to 1 cm longest axis
    • Karnofsky index ≥ 40
    • No systemic lymphoma on [18F]–FDG PET-CT
    • Creatinine clearance ≥ 30 ml / min
    • Social security affiliation (excluding AME)
    • Signature of informed consent by the patient or by a legal representative or the close relative if the patient is not in a position to do so
    • Patients âgés de ≥ 18 ans
    • Diagnostic de lymphome cérébral de haut grade nouvellement diagnostiqué (confirmation histologique et/ou cytologique)
    • Patient naïf de traitement par chimiothérapie ou radiothérapie pour le lymphome du SNC
    • Masse tumorale intra-cérébrale supérieure ou égale à 1 cm de plus grand axe et prenant le contraste en IRM
    • Index de Karnofsky ≥ 40
    • Pas de signe de lymphome systémique sur le TEP-TDM au [18F]-FDG
    • Clairance de la créatinine ≥ 30 ml/min
    • Affiliation à la sécurité sociale (hors AME)
    • Signature du consentement éclairé par le patient ou par la personne de confiance ou un proche si le patient n’est pas en état de le faire
    E.4Principal exclusion criteria
    • Hypersensitivity to the active substance, to any of the excipients or to any of the components of [18F] -Fludarabine or gadolinium
    • Previous treatment for primary CNS lymphoma
    • Isolated primary vitro-retinal lymphoma
    • Isolated CNS relapse of a systemic lymphoma
    • Other active cancer except basal cell carcinoma of the skin or / and cervical cancer in situ
    • Immunosuppression (organ transplant in particular)
    • Positive HIV serology
    • Presence of another progressive pathology that is life-threatening in the short term
    • Treatment with dipyridamole
    • History of allergy to gadolinium chelates (DOTAREM®)
    • Absolute contraindication to MRI (pacemaker, cochlear implant ect), to the administration of [18F] FDG or gadolinium
    • Severe cognitive impairment incompatible with good cooperation in the PET-MRI examination
    • Patient with pain or restlessness unable to remain motionless in the supine position for 60 minutes
    • Weight> 100 Kg
    • Patient of childbearing potential without effective contraception or breastfeeding
    • Patient deprived of liberty or under legal protection (guardianship or curatorship)
    • Ongoing participation in another intervention research protocol. Participation in research of a non-interventional type is authorized.
    • Vulnerable population (pregnant or breastfeeding women)
    • Hypersensibilité à la substance active, à l’un des excipients ou à l’un des composants de la [18F]-Fludarabine ou du gadolinium
    • Traitement antérieur pour un lymphome primitif du système nerveux central
    • Lymphome primitif vitro-rétinien isolé
    • Rechute neurologique isolée d’un lymphome systémique
    • Autre cancer actif à l’exception d’un carcinome baso-cellulaire cutané ou/et d’un cancer du col utérin in situ
    • Immunodépression (greffe d’organe notamment)
    • Sérologie HIV positive
    • Présence d’une autre pathologie évolutive engageant le pronostic vital à court terme
    • Traitement par dipyridamole
    • Antécédent d’allergie aux chélates de gadolinium (DOTAREM®)
    • Contre-indication absolue à l’IRM (pacemaker, implant cochléaire ect), à l’administration de [18F] FDG ou de gadolinium
    • Présence de troubles cognitifs incompatibles avec une bonne coopération à l’examen TEP-IRM
    • Patient algique ou agité ne pouvant rester immobile en décubitus dorsal pendant 60 minutes
    • Poids > 100 Kg
    • Patiente en âge de procréer sans contraception efficace ou allaitante
    • Patient privé de liberté ou sous protection juridique (tutelle ou curatelle)
    • Participation en cours à un autre protocole de recherche interventionnelle. La participation aux recherches de type non interventionnel est autorisée.
    • Population vulnérable (femme enceinte ou allaitante)
    E.5 End points
    E.5.1Primary end point(s)
    Measurements of [18F] -Fludarabine uptake in tumoral lesions and normal tissue using SUV, tumor/normal tissues ratios, on PET images fused with MRI.
    Mesure de la fixation de la [18F]-Fludarabine (standard uptake value ou SUVmax) dans les lésions tumorales, rapportée au SUVmax du tissu sain quantifié sur les images TEP fusionnées à l’IRM.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After the brain exam
    Après la réalisation de l'examen cérébral
    E.5.2Secondary end point(s)
    The secondary evaluation criteria related to the stated objectives are:
    - Cerebral distribution of [18F] -Fludarabine in healthy and tumoral tissues
    - Temporal activity curves of [18F] -Fludarabine in healthy and tumoral tissues
    - Tumor SUVmax, tumor/healthy tissue ratio in PET- [18F] -FDG
    - Volumes of contrast enhancement in post-gadolinium T1-weighted MR sequence
    - Hypersignal in diffusion-weighted sequence and apparent diffusion coefficient (ADC)
    - Tumor perfusion, capillary permeability in perfusion weighted MRI
    - metabolite ratios in spectroscopy
    Les critères d’évaluation secondaires en rapport avec les objectifs énoncés sont :
    - Distribution cérébrale de [18F]-Fludarabine dans les tissus sain et lésionnel
    - Courbes d’activité temporelle de [18F]-Fludarabine dans les tissus sain et lésionnel
    - SUVmax tumoral, contraste tumeur/tissu sain en TEP-[18F]-FDG
    - volumes de la prise de contraste en IRM 3D T1 avec injection de Gadolinium
    - hypersignal en IRM de diffusion et coefficient de diffusion apparent (CDA)
    - perfusion tumorale, perméabilité capillaire en IRM de perfusion
    - rapports de métabolites en spectroscopie
    E.5.2.1Timepoint(s) of evaluation of this end point
    After the brain exam
    Après la réalisation de l'examen cérébral
    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 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
    Last Visit of the Last Subject
    Dernière visite du dernier patient inclus
    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 months12
    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: 3
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state8
    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 Decision2022-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-07
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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