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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43936   clinical trials with a EudraCT protocol, of which   7310   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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    EudraCT Number:2015-000377-12
    Sponsor's Protocol Code Number:CHUBX2014/26
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-07-12
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2015-000377-12
    A.3Full title of the trial
    MISOBOLD - Prostate cancer hypoxia using BOLD MRI and 18F-FMISO PET imaging
    Imagerie de l'hypoxie par IRM fonctionnelle BOLD et TEP-TDM au
    18F-Misonidazole (18F-FMISO) des tumeurs de prostate à haut risque (MISOBOLD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MISOBOLD - Prostate cancer hypoxia using BOLD MRI and 18F-FMISO PET imaging
    MISOBOLD: hypoxie des tumeurs de prostate à haut risque par IRM fonctionnelle BOLD et TEP-TDM au 18F-Misonidazole (18F-FMISO).
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberCHUBX2014/26
    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 SponsorCHU de Bordeaux
    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 supportAppel à Projets Interrégional en Cancérologie (API-K) 2014
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Bordeaux
    B.5.2Functional name of contact pointSophie Regueme
    B.5.3 Address:
    B.5.3.1Street Address12 rue Dubernat
    B.5.3.2Town/ cityTalence cedex
    B.5.3.3Post code33404
    B.5.4Telephone number+33557821067
    B.5.5Fax number+33556794926
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP Role
    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]Fluoromisonidazole-3-fluoro-1-(2'-nitro-1'-imidazolyl)-2-propanol
    D.3.2Product code 18F-FMISO
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Prostate cancer
    Tumeur de la prostate à haut risque
    E.1.1.1Medical condition in easily understood language
    Prostate cancer
    Cancer de la prostate
    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 PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate 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 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 determine the ability of two imaging modalities (MRI BOLD and PET withFMISO) to demonstrate the hypoxic character of high-risk metastatic prostate tumors by comparing their results after prostatic segmentation with those from histological analysis of surgical specimens.
    Déterminer la capacité de deux modalités d’imagerie (IRM BOLD et TEP au FMISO) de mettre en évidence le caractère hypoxique de tumeurs de prostate à haut risque métastatique, en comparant leurs résultats après segmentation prostatique à ceux de l’analyse histologique des pièces opératoires.
    E.2.2Secondary objectives of the trial
    • Compare the inter-individual variability of hypoxia measurements according to two different modalities,
    • Provide imaging information for planning volumes in prostate tumor radiotherapy
    • Comparer la variabilité interindividuelle des mesures de l’hypoxie selon les différentes modalités,
    • Proposer des informations d’imagerie pour la planification des volumes en radiothérapie des tumeurs de prostate
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patient above 18 yrs old.
    • Prostate tumor with histological confirmed diagnosis and highly radiological suspected target on MRI
    • High risk patient : >T2c grade, Glasgow score > 7 and PSA > 20ng/ml
    • Surgical treatment chosen during multidisciplinary meeting
    • ECOG ≤2
    • Patient must have undergone MRI with BOLD sequence less than 6 month prior surgery
    • Informed signed consent.
    • Member or beneficiary of a social security system.
    • Patient de plus de 18 ans,
    • Diagnostic anatomopathologique et radiologique initial de tumeur de prostate,
    • Patient estimé à haut risque : stade >T2c, score Gleason>7, PSA>20 ng/ml
    • Prise en charge chirurgicale retenue en RCP,
    • ECOG≤2,
    • Ayant eu une IRM avec la séquence BOLD datant de moins de 6 mois avant la chirurgie
    • Consentement écrit éclairé signé,
    • Patient affilié à un régime de sécurité sociale,
    E.4Principal exclusion criteria
    • Patient included in another clinical study
    • Geographical, social or psychological reasons preventing patient from submitting to the study’s medical monitoring
    • Patient deprive of liberty, adult subjects to legal protection or unable to give consent
    • Contraindication to MRI
    • Contraindication to gadolinium injection
    • Patient inclus dans une autre étude clinique,
    • Impossibilité de se soumettre au suivi médical de l'essai pour des raisons géographiques, sociales ou psychiques,
    • Patient privé de liberté et majeur faisant l’objet d’une mesure de protection légale ou hors d’état d’exprimer son consentement,
    • Contre-indication à l’IRM
    • Contre-indication à l’injection de chélates de gadolinium
    E.5 End points
    E.5.1Primary end point(s)
    The main endpoint is the hypoxic character of the different prostate segments measured by imaging (MRI BOLD and PET at FMISO) and compare it to the results of the histological analysis of surgical specimens using histologic markers (HIF and CAIX)
    Le critère de jugement principal est le caractère hypoxique des différents segments prostatiques mesuré par imagerie (IRM BOLD et TEP au FMISO) et le comparer aux résultats de l’analyse histologique des pièces opératoires chez les patients présentant des tumeurs prostatiques de haut risque grâce à l’utilisation des marqueurs histologiques HIF et CAIX.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 months
    E.5.2Secondary end point(s)
    • Compare the inter-individual variability of the hypoxia measurements according to the different modalities: an inter-individual analysis of the quantitative values will be carried out.
    • Compare the performance of multiparametric prostatic MRI with the BOLD sequence relative to the histological examination of the surgical specimens: an analysis of MRI performance will be performed by comparing ROC curves
    • Comparer la variabilité interindividuelle des mesures de l’hypoxie selon les différentes modalités : une analyse interindividuelle des valeurs quantitatives sera effectuée.
    • Comparer les performances de l’IRM prostatique multiparamétrique incluant la séquence BOLD par rapport à l’examen histologique des pièces opératoires : une analyse des performances de l’IRM sera effectuée par comparaison de courbes ROC
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 months
    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 Yes
    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. 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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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)
    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 Decision2017-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-18
    P. End of Trial
    P.End of Trial StatusOngoing
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