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    Summary
    EudraCT Number:2016-002589-30
    Sponsor's Protocol Code Number:CHUBX2015/17
    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:2017-03-17
    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 number2016-002589-30
    A.3Full title of the trial
    Dynamic Contrast enhanced ultrasound for predict and assess rectal cancer response after neo-adjuvant chemoradiation – RECT
    Radio-chimiothérapie du cancer rectal : Apport de l’échographie de contraste quantitative pour prédire et évaluer la réponse tumorale - RECT
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dynamic Contrast enhanced ultrasound for predict and assess rectal cancer response after neo-adjuvant chemoradiation – RECT
    Radio-chimiothérapie du cancer rectal : Apport de l’échographie de contraste quantitative pour prédire et évaluer la réponse tumorale - RECT
    A.3.2Name or abbreviated title of the trial where available
    RECT
    RECT
    A.4.1Sponsor's protocol code numberCHUBX2015/17
    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.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 supportAPI-K 2015
    B.4.2CountryFrance
    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 pointTABUTEAU Sophie
    B.5.3 Address:
    B.5.3.1Street Address12 RUE DUBERNAT
    B.5.3.2Town/ cityTALENCE
    B.5.3.3Post code33404
    B.5.3.4CountryFrance
    B.5.4Telephone number33557821066
    B.5.5Fax number33556794926
    B.5.6E-mailsophie.tabuteau@chu-bordeaux.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.2.1.1.1Trade name SonoVue
    D.2.1.1.2Name of the Marketing Authorisation holderBRACCO International B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameSonoVue
    D.3.2Product code V08DA05
    D.3.4Pharmaceutical form Powder and solvent for dispersion 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 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
    Rectal Cancer
    Cancer du rectum
    E.1.1.1Medical condition in easily understood language
    Rectal Cancer
    Cancer du rectum
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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 assess the predictive value of perfusion parameters before CRT for tumor response grade
    Evaluer la valeur prédictive des paramètres de perfusion (aire sous la courbe) mesurés par échographie de contraste quantitative avant chimiothérapie d’induction et/ou RCT pour la réponse tumorale anatomopathologique du cancer rectal allant bénéficier d’une RCT néoadjuvante. (+/- chimiothérapie première)
    E.2.2Secondary objectives of the trial
    - To assess the correlation between perfusion parameters changes after CRT and the tumor response grade to CRT
    - To assess the correlation between perfusion parameters changes after chemotherapy and the tumor response grade to chemotherapy
    - To assess the predictive value of perfusion parameters before CRT for tumor response grade assessed by MRI
    - To assess the correlation between perfusion parameters and the mrTNM
    - To assess the reliability and reprodutibility of perfusion parameters measurements
    - Evaluer la valeur prédictive des autres paramètres de perfusion (intensité du pic, temps de montée, AUC du remplissage, temps de transit moyen, temps au pic, pente maximale de remplissage, taux d’élimination)
    - Evaluer la valeur prédictive des modifications des paramètres de perfusion (delta-Aire sous la courbe, intensité du pic, temps de montée, AUC du remplissage, temps de transit moyen, temps au pic, pente maximale de remplissage, taux d’élimination)
    - Evaluer la corrélation entre les modifications des paramètres de perfusion mesurés par échographie de contraste quantitative et l’évaluation de la réponse à RCT néoadjuvante par IRM (mr TRG).
    - Corréler les paramètres de perfusion mesurés par échographie de contraste quantitative avant RCT néoadjuvante avec le statut mrTNM pré-opératoire (notamment l’attente ganglionnaire).
    - Evaluer la reproductibilité des mesures des paramètres de perfusion entre 2 radiologues : reproductibilité intra et inter-observateur.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically confirmed rectal carcinoma
    - Stade ≥T2 and tumor size ≥3cm
    - No detectable metastases
    - Patient ≥ 18 years
    - Patient information and written informed consent form signed
    - Patient who can receive radiotherapy and chemotherapy
    - Negative pregnancy test in women of childbearing potential
    - Patient covered by a Social Security system
    - Patient majeur, affilié ou bénéficiaire d’un régime de sécurité sociale
    - Consentement écrit, libre, éclairé et signé par le patient et l’investigateur (avant tout examen nécessité par l’étude)
    - Tumeur du bas ou moyen rectum prouvée histologiquement
    - Tumeur du bas ou moyen rectum de stade ≥T2 et de taille ≥3cm nécessitant une RCT néoadjuvante
    E.4Principal exclusion criteria
    - Indication for immediate surgery
    - Primary tumor not measured at the MRI before inclusion
    - Previous pelvic radiotherapy
    - Contraindication to SONOVUE or MRI
    - Tumeur opérable d’emblée
    - Lésion tumorale du haut rectum
    - Lésion tumorale sténosante
    - Antécédent de radiothérapie pelvienne
    - Tumeur non mesurable en IRM
    - Métastases

    Critères relatifs aux contre-indications à la procédure étudiée :
    - Syndrome coronarien aigu et récent, cardiopathie ischémique instable : infarctus du myocarde en phase de constitution ou en évolution, angor typique de repos dans les 7 jours précédents, aggravation significative de la symptomatologie cardiaque dans les 7 jours précédents, intervention récente sur les artères coronaires ou tout autre facteur suggérant une instabilité clinique (par exemple, altération récente de l’ECG, modification des paramètres cliniques ou biologiques), insuffisance cardiaque aiguë, insuffisance cardiaque stade III ou IV, troubles du rythme sévères
    - Shunt droit-gauche
    - Hypertension artérielle pulmonaire sévère (pression artérielle pulmonaire > 90 mmHg)
    - Hypertension artérielle systémique non contrôlée
    - Syndrome de détresse respiratoire
    - Bronchopneumopathie chronique obstructive (BPCO) sévère
    - Endocardite aiguë
    - Implant de prothèses valvulaires
    - Maladie inflammatoire systémique aiguë et/ou sepsis
    - Accident thromboembolique récent
    - Stade terminal de maladie rénale ou hépatique
    - Hypersensibilité à l'hexafluorure de soufre ou à l'un des autres composants de Sonovue
    E.5 End points
    E.5.1Primary end point(s)
    Area under the curve of intensity of the signal / time acquired before any treatment
    Aire sous la courbe d’intensité du signal/temps acquis avant tout traitement
    E.5.1.1Timepoint(s) of evaluation of this end point
    Before chemoradiotherapy
    Avant la radiochimiothérapie
    E.5.2Secondary end point(s)
    1. Perfusion parameters (peak enhancement PE, rise time RT, wash-in area under the curve WiAUC, mean transit time mTT, time to peak TTP, wash-in rate WiR, wash out rate WoR)

    2. Changes in perfusion parameters (ΔAUC, ΔPE, ΔRT, ΔWiAUC, ΔmTT, ΔTTP, ΔWiR, ΔWoR)

    3. Perfusion parameters and MR TRG grading

    4. Union for International Cancer Control TNM staging

    5. Inter- and intra-class correlation coefficient
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. After chemotherapy (v2 arm A), after chemoradiotherapy (v3 both arm)

    2. Before treatment (v1 both arm), after chemotherapy (v2 arm A), after chemoradiotherapy (v3 both arm)

    3. Perfusion before treatment (v1 both arm), MRI after chemotherapy (v2 arm A) and after chemoradiotherapy (v3 both arm)

    4. Time point: perfusion before treatment (v1 both arm), MRI after chemotherapy (v2 arm A) and after chemoradiotherapy (v3 both arm)

    5. Time point: v1 both arm, v2 arm A, v3 both arm
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    LVLS
    DVDP
    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) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    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 state
    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 Decision2018-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-01-08
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