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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:2018-001879-20
    Sponsor's Protocol Code Number:38RC18.085
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-29
    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 number2018-001879-20
    A.3Full title of the trial
    Radiotherapy of multiple brain metastases using AGuIX® gadolinium-chelated polysiloxane based nanoparticles: a prospective randomized phase II clinical trial.
    Traitement de métastases cérébrales multiples par Radiothérapie et nanoparticule de gadolinium, AGuiX® : étude prospective randomisée de phase II.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Radiotherapy of multiple brain metastases using AGuIX® gadolinium-chelated polysiloxane based nanoparticles: a prospective randomized phase II clinical trial.
    Traitement de métastases cérébrales multiples par Radiothérapie et nanoparticule de gadolinium, AGuiX® : étude prospective randomisée de phase II.
    A.3.2Name or abbreviated title of the trial where available
    NANORAD2
    A.4.1Sponsor's protocol code number38RC18.085
    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 SponsorGrenoble Alps University Hospital
    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 supportNH TherAguix
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGrenoble Alps University Hospital
    B.5.2Functional name of contact pointAdolle Anaïs
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Clinical Research and Innovation Pavillon Dauphiné
    B.5.3.2Town/ cityGrenoble
    B.5.3.3Post code38043
    B.5.3.4CountryFrance
    B.5.4Telephone number33(0)476 76 68 13
    B.5.5Fax number33(0)476 76 52 21
    B.5.6E-mailAAdolle@chu-grenoble.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 nameAGuIX
    D.3.4Pharmaceutical form Lyophilisate for 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 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 Yes
    D.3.11.13.1Other medicinal product typeNanoparticles
    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 brain metastases, from a histologically confirmed solid tumor, eligible for WBRT
    Métastases cérébrales multiples d’un cancer prouvé histologiquement
    E.1.1.1Medical condition in easily understood language
    Patients with brain metastases eligible for WBRT
    Patients avec des métastases cérébrales éligibles à la radiothérapie
    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 10006128
    E.1.2Term Brain metastases
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The Objective Intracranial Response is defined as having intracranial Complete Response (CR) or intracranial Partial Response (PR) for brain metastasis, assessed by contrast-enhanced MRI using RECIST v1.1 criteria.
    Meilleur taux de réponse intracrânien objectif (à 6 semaines et 3 mois)
    E.2.2Secondary objectives of the trial
    - Quality of life test (EORTC QLQ C30 and EORTC QLQ BN20)
    - Neurocognitive test (MoCA)
    - Evaluation of brain metastases response on Per protocol population, according to RECIST v1.1 criteria (or modified RECIST), by MRI at 6 weeks and 3 months, with MRI centralized reading on Per protocol
    - Evaluation of brain metastases response, according to RANO, to RECIST v1.1 criteria, and as the evolution of the sum of longest diameters (for all metastases with a sum of diameters > 1cm), by MRI at 6 weeks and 3, 6, 9 and 12 months
    - Evaluation of individual brain metastasis response, for all metastases with the sum of diameters > 1cm, by MRI rate at 6 weeks and 3, 6, 9 and 12 months
    - Death related to brain metastases progression
    - Death
    - Reporting of daily steroid dose
    - MRI evaluation of contrast enhancement at D0 after AGuIX® injection
    - Reporting of adverse events by type, frequency and severity for both treatments (WBRT and AGuIX® + WBRT).
    - Evaluation de la qualité de vie
    - Evaluation neurocognitive
    - Evaluation de la réponse intracrânienne à 6 semaines, 3, 6, 9 et 12 mois
    - Evaluation de la réponse individuelle des métastases à 6 semaines, 3, 6, 9 et 12 mois
    - Survie sans progression intracrânienne
    - Survie à 6 mois
    - Survie cérébrale
    - Survie globale
    - Changement dans la dépendance aux stéroïdes
    - Etude par IRM de la distribution et de l’élimination du produit dans les métastases cérébrales
    - Incidence événements indésirables
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Objective: MRI evaluation of the distribution and quantification of AGuIX® in brain metastases after injection of AGuIX®-
    Population: 20 patients
    Evaluation par IRM de la cinétique de distribution et d’accumulation de l’AGuIX® dans les métastases cérébrales après la troisième injection d’AGuIX® (20 patients).
    E.3Principal inclusion criteria
    - Patients with brain metastases, from a histologically confirmed solid tumor, eligible for WBRT
    - At least 18 years old
    - Signed informed consent after informing the patient
    - ECOG (Eastern Cooperative Oncology Group) performans status 0-2
    - Extracranial disease:
    • Complete or partial response or stability under systemic treatment
    • No extracranial disease
    • Or first line of treatment
    - Life expectancy greater than 6 weeks
    - No renal insufficiency
    (glomerular filtration rate ≥ 50 mL/min/1.73m²)
    - Affiliated to a social security regimen
    - Effective methods of contraception must be used throughout the study .
    - Métastases cérébrales multiples d’un cancer prouvé histologiquement, éligible à l’IET
    - Age ≥ 18 ans sans limite d’âge supérieure
    - Capacité de consentement éclairé écrit et signé
    - Statut ECOG 0-2
    - Pathologie extra-crânienne :
    o Réponse complète, partielle ou stabilisés sous traitement systémique
    o Pas de pathologie extra-crânienne
    o Ou en traitement de première ligne
    - Espérance de vie > 6 mois
    - Absence d’insuffisance rénale (DFG ≥ 50 mL/min/1.73m²)
    - Affilié à un régime de sécurité social ou bénéficiaire d’un tel régime
    - Méthode de contraception efficace sur toute la durée de l’étude
    E.4Principal exclusion criteria
    - Leptomeningeal metastasis
    - Evidence of metastasis with recent large hemorrhage
    - Progressive and threatening extracranial disease under systemic treatment
    - Previous cranial irradiation (except stereotactic irradiation)
    - Known contra-indication, sensitivity or allergy to gadolinium
    - Known contra-indication for Magnetic Resonance Imaging
    - Inclusion in another clinical trial protocol
    - Pregnancy or breastfeeding
    - Subject in exclusion period of another study
    - Subject under administrative or judicial control
    - Pathologie leptiméningée
    - Preuve d’une métastase avec hémorragie importante récente
    - Pathologie extra-crânienne en progression sous traitement systémique
    - Antécédent d’irradiation crânienne (à l’exception d’une irradiation stéréotaxique)
    - Contre-indication, hypersensibilité ou allergie connue au gadolinium
    - Contre-indication connue à l’IRM
    - Inclusion dans un autre essai clinique
    - Femme enceinte ou parturiente
    - Personnes décrites aux articles L1121-6 et L1121-8 (personnes privées de liberté par une décision judiciaire ou administrative, personnes majeures faisant l’objet d’une mesure de protection légale ou hors d’état d’exprimer leur consentement)
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of brain metastases response, according to RECIST v1.1 criteria (or modified RECIST), by MRI at 6 weeks and 3 months, with MRI centralized reading
    Evaluation de la taille et de la réponse de métastases cérébrales basée sur les critères RECIST v1.1 (ou RECIST modifié) par IRM à 6 semaines et 3 mois, par lecture centralisée des IRM.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 weeks and 3 months
    6 semaines et 3 mois
    E.5.2Secondary end point(s)
    - Quality of life test (EORTC QLQ C30 and EORTC QLQ BN20)
    - Neurocognitive test (MoCA)
    - Evaluation of brain metastases response on Per protocol population, according to RECIST v1.1 criteria (or modified RECIST), by MRI at 6 weeks and 3 months, with MRI centralized reading on Per protocol
    - Evaluation of brain metastases response, according to RANO, to RECIST v1.1 criteria, and as the evolution of the sum of longest diameters (for all metastases with a sum of diameters > 1cm), by MRI at 6 weeks and 3, 6, 9 and 12 months
    - Evaluation of individual brain metastasis response, for all metastases with the sum of diameters > 1cm, by MRI rate at 6 weeks and 3, 6, 9 and 12 months
    - Death related to brain metastases progression
    - Death
    - Reporting of daily steroid dose
    - MRI evaluation of contrast enhancement at D0 after AGuIX® injection
    - Reporting of adverse events by type, frequency and severity for both treatments (WBRT and AGuIX® + WBRT).
    - Questionnaires de qualité de vie (EORTC QLQ C30 et EORTC QLQ BN20)
    - Tests neurocognitifs (MoCA)
    - Evaluation de la taille et de la réponse des métastases cérébrales par les critères RECIST v1.1 et RANO, et par l’évolution de la somme des diamètres les plus longs (pour toutes les métastases avec une somme de diamètres > 1cm) par IRM à 6 semaines, 3, 6, 9 et 12 mois.
    - Evaluation de la réponse individuelle des métastases pour toutes les métastases avec une somme des diamètres > 1 cm, par IRM à 6 semaines, 3, 6, 9 et 12 mois
    - Décès lié à la progression des métastases cérébrales
    - Décès
    - Dose journalière de stéroïde
    - Evaluation par IRM de la majoration de contraste à J0 après injection d’AGuIX®
    - Recueil des évènements indésirables par type, fréquence et sévérité pour les deux bras de traitement
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 weeks, 3, 6, 9 and 12 months
    6 semaines, 3, 6, 9 et 12 mois
    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 Yes
    E.6.5Efficacy Yes
    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 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
    Standard therapy
    E.8.2.4Number of treatment arms in the trial2
    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 concerned10
    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 Information not present in EudraCT
    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 years
    E.8.9.1In the Member State concerned months36
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    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 state100
    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 Decision2018-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-09-30
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