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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2020-000993-27
    Sponsor's Protocol Code Number:2019PI115
    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:2020-05-25
    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 number2020-000993-27
    A.3Full title of the trial
    AGATA: Value of contrast-enhanced ultrasound in adnexal torsion
    AGATA: Apport diagnostic de l’échoGraphie de contrAste dans la Torsion Annexielle
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Value of contrast-enhanced ultrasound for diagnosis of ovarian torsion
    Apport de l'échographie avec injection de produit de contraste pour diagnostiquer la torsion d'ovaire
    A.3.2Name or abbreviated title of the trial where available
    AGATA
    AGATA
    A.4.1Sponsor's protocol code number2019PI115
    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 SponsorCHRU NANCY
    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 supportCHRU NANCY
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHRU NANCY
    B.5.2Functional name of contact pointProject manager
    B.5.3 Address:
    B.5.3.1Street AddressCHRU Nancy Direction de la Recherche et de l'Innovation Rue du Morvan
    B.5.3.2Town/ cityVANDOEUVRE LES NANCY
    B.5.3.3Post code54500
    B.5.3.4CountryFrance
    B.5.4Telephone number+330383155285
    B.5.5Fax number+330383157451
    B.5.6E-maildripromoteur@chru-nancy.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 Yes
    D.2.1.1.1Trade name SONOVUE
    D.2.1.1.2Name of the Marketing Authorisation holderBRACCO International B.V. Strawinskylaan 3051 NL - 1077 ZX Amsterdam Pays-Bas
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSULPHUR HEXAFLUORIDE
    D.3.9.1CAS number 2551-62-4
    D.3.9.2Current sponsor codeSONOVUE
    D.3.9.3Other descriptive nameSULFUR HEXAFLUORIDE
    D.3.9.4EV Substance CodeSUB15925MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    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
    Adnexal torsion
    Torsion Annexielle
    E.1.1.1Medical condition in easily understood language
    Ovarian torsion
    Torsion de l'ovaire
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10044069
    E.1.2Term Torsion of ovary
    E.1.2System Organ Class 100000004872
    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 diagnostic performance of contrast-enhanced ultrasound for the diagnosis of adnexal torsion in women with suspected adnexal torsion.
    Evaluer la performance diagnostique de l’échographie avec produit de contraste pour le diagnostic de la torsion annexielle chez les femmes avec suspicion de torsion annexielle.
    E.2.2Secondary objectives of the trial
    OS1: To describe the vascularization parameters of the ovaries in contrast-enhanced ultrasound.
    OS2: To compare the diagnostic performance of contrast-enhanced ultrasound and 2D Doppler Ultrasound for the detection of adnexal torsion.
    OS3: To describe the vascular parameters of the ovary according to the degree of adnexal torsion.
    OS1: Décrire les paramètres de vascularisation des ovaires en échographie de contraste.
    OS2: Comparer les performances diagnostiques de l’échographie de contraste et de l’échographie Doppler 2D pour la mise en évidence de la torsion annexielle.
    OS3: Décrire les paramètres vasculaires de l’ovaire en fonction du degré de torsion annexielle.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age ≥ 18 years
    Planned surgery for suspected adnexal torsion
    Being affiliated to the Social Security system or benefiting from such a system
    Have received full information about the organization of the study and have signed their informed consent
    Age ≥18 ans
    Indication chirurgicale prévue pour une suspicion de torsion annexielle
    Etre affiliée au régime de Sécurité Sociale ou bénéficiant d’un tel régime
    Avoir reçu l’information complète sur l’organisation de la recherche et ayant signé son consentement éclairé
    E.4Principal exclusion criteria
    "Any medical condition that contraindicates the administration of SonoVue® , in particular :
    o Documented hypersensitivity to sulfur hexafluoride or any of the other components of SonoVue
    o Woman with acute coronary syndrome or unstable ischemic heart disease
    o Woman with acute endocarditis
    o Woman with prosthetic valves
    o Woman with acute systemic inflammatory disease and/or sepsis
    o Woman in a state of hypercoagulation and/or recent thromboembolic event
    o Woman with end-stage kidney or liver disease
    o Woman with right-left shunt, severe pulmonary arterial hypertension (pulmonary arterial pressure > 90 mmHg)
    o Woman with uncontrolled systemic hypertension
    o Woman with respiratory distress syndrome"
    "Persons referred in Articles L. 1121-5, L. 1121-7 and L1121-8 of French Public Health Code :
    o Pregnant woman, parturient or breastfeeding mother
    o Minor person (not emancipated)
    o Adult person under legal protection (guardianship, curatorship, legal safeguard)
    o Adult who is unable to give consent "
    Persons who are deprived of their liberty by a judicial or administrative decision, persons under psychiatric care pursuant to articles L. 3212-1 and L. 3213-1
    "Toute situation médicale contre-indiquant l’administration du SonoVue®, notamment :
    o Hypersensibilité connue à l’hexafluorure de soufre ou à l’un des autres composants de SonoVue
    o Femme ayant présenté un syndrome coronarien aigu ou atteinte d’une cardiopathie ischémique instable
    o Femme ayant une endocardite aiguë
    o Femme ayant des prothèses valvulaires
    o Femme ayant une maladie inflammatoire systémique aiguë et/ou sepsis
    o Femme en états d'hypercoagulation et/ou accident thromboembolique récent
    o Femme en stade terminal de maladie rénale ou hépatique
    o Femme porteuse d’un shunt droit-gauche, d’une hypertension artérielle pulmonaire sévère (pression artérielle pulmonaire > 90 mmHg)
    o Femme ayant une hypertension systémique non contrôlée
    o Femme ayant un syndrome de détresse respiratoire"
    "Personnes visées aux articles L. 1121-5, L. 1121-7 et L1121-8 du code de la santé publique :
    o Femme enceinte, parturiente ou mère qui allaite
    o Personne mineure (non émancipé)
    o Personne majeure faisant l’objet d’une mesure de protection légale (tutelle, curatelle, sauvegarde de justice)
    o Personne majeure hors d’état d’exprimer son consentement
    "
    Les personnes privées de liberté par une décision judiciaire ou administrative, les personnes faisant l’objet de soins psychiatriques en vertu des articles L. 3212-1 et L. 3213-1
    E.5 End points
    E.5.1Primary end point(s)
    "Measurement of signal intensity to assess the sensitivity, specificity, positive predictive value and negative predictive value of ultrasound with contrast agent for the detection of adnexal torsion, in women adnexal torsion suspected, with ROC (Receiver Operating Characteristics) curves.
    The presence or not of adnexal torsion is confirmed during surgery (or diagnostic and therapeutic laparoscopy or laparotomy = reference method)."
    "Mesure de l’intensité de signal pour évaluer la sensibilité, la spécificité, la valeur prédictive positive et la valeur prédictive négative de l’échographie avec produit de contraste pour la détection de la torsion annexielle chez les femmes avec suspicion de torsion annexielle avec réalisation de courbes ROC (Receiver Operating Characteristics).
    La présence ou l’absence de la torsion annexielle est confirmée lors de l’intervention chirurgicale (cœlioscopie ou laparotomie diagnostique et thérapeutique = méthode de référence).
    "
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 0 (D0)
    Jour 0 (J0)
    E.5.2Secondary end point(s)
    CES1 : Measurement of the vascularisation parameters of the suspected torsional ovary and the contralateral ovary if available: signal intensity and perfusion kinetics.
    CES 2 : Measurement of signal intensities to evaluate sensitivities and specificities of contrast ultrasound and 2D Doppler ultrasound.
    CES3 : Comparison of ovarian vascularization parameters with the degree of adnexal torsion. The degree of torsion is defined by the number of turns (number of rotations around the axis) detected during surgery for detorsion under laparoscopy.
    CES1 : Mesure des paramètres de vascularisation de l’ovaire suspecté de torsion et de l’ovaire controlatéral si disponible : intensité de signal et cinétique de perfusion.
    CES2 : Mesure des intensités de signal pour évaluer les sensibilités et spécificités de l’échographie de contraste et de l’échographie Doppler 2D.
    CES3 : Comparaison des paramètres de vascularisation de l’ovaire avec le degré de la torsion d’annexe. Le degré de torsion est défini par le nombre de spires (nombre de tours autour de l’axe) détectés lors de l’intervention chirurgicale pour la détorsion sous cœlioscopie.
    E.5.2.1Timepoint(s) of evaluation of this end point
    CES1 : Day 0 (D0)
    CES2 : Day 0 (D0)
    CES3 : Day 0 (D0)
    CES1 : Jour 0 (J0)
    CES2 : Jour 0 (J0)
    CES3 : Jour 0 (J0)
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    E.8.2.3.1Comparator description
    Groupe control : pas de torsion annexielle / Groupe torsion : torsion confirmée(partielle ou totale)
    Control group : no adnexal torsion / torsion group : confirmed torsion (partial or total)
    E.8.2.4Number of treatment arms in the trial1
    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
    hospital discharge or 24 hours maximum
    Sortie d'hospitalisation ou à 24 heures maximum
    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 days1
    E.8.9.2In all countries concerned by the trial months36
    E.8.9.2In all countries concerned by the trial days1
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state30
    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)
    The patient continues the standard procedure as part of the usual management of suspected adnexal torsion.
    Le patient continu la procédure standard prévue dans le cadre de la prise en charge habituelle d'une suspicion de torsion annexielle.
    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 Decision2020-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-30
    P. End of Trial
    P.End of Trial StatusOngoing
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