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    Summary
    EudraCT Number:2020-005189-32
    Sponsor's Protocol Code Number:29BRC20.0208
    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:2020-12-04
    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 number2020-005189-32
    A.3Full title of the trial
    Contribution of indocyanine green angiography in the detection of parathyroids and the prevention of hypoparathyroidism post total thyroidectomy
    Apport de l’angiographie au vert d’indocyanine dans la détection des parathyroïdes et la prévention de l’hypoparathyroïdie post thyroïdectomie totale
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Contribution of indocyanine green angiography in the detection of parathyroids and the prevention of hypoparathyroidism post total thyroidectomy
    Apport de l’angiographie au vert d’indocyanine dans la détection des parathyroïdes et la prévention de l’hypoparathyroïdie post thyroïdectomie totale
    A.3.2Name or abbreviated title of the trial where available
    HYPOCAAVI
    HYPOCAAVI
    A.4.1Sponsor's protocol code number29BRC20.0208
    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 de Brest
    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 de Brest
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHRU de Brest
    B.5.2Functional name of contact pointPELOUIN
    B.5.3 Address:
    B.5.3.1Street AddressDRCI - Hopital Morvan - 2 avenue Foch
    B.5.3.2Town/ cityBrest
    B.5.3.3Post code29200
    B.5.3.4CountryFrance
    B.5.4Telephone number00330229020117
    B.5.5Fax number00330298223183
    B.5.6E-mailpromotion-interne@chu-brest.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 Infracyanine
    D.2.1.1.2Name of the Marketing Authorisation holderSERB
    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 solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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
    Thyroidectomy total
    Thyroïdectomie totale
    E.1.1.1Medical condition in easily understood language
    Thyroidectomy total
    Thyroïdectomie totale
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10043777
    E.1.2Term Thyroidectomy total
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the frequency of postoperative hypocalcemia corrected by albumin (below 2 mmol/L, sign associated to hypoparathyroidism) between control group and group with use of ICG.
    Comparer la fréquence d’hypocalcémie corrigée par l'albumine (calcémie inférieure à 2 mmol/L, signe associé à l’hypoparathyroïdie) postopératoire entre le groupe avec utilisation du vert d’indocyanine vs le groupe sans utilisation du vert d’indocyanine.
    E.2.2Secondary objectives of the trial
    1/ To assess the contribution of angiography with ICG in the modification of definitive hypoparathyroidism rate post total thyroidectomy (D8, M1, M6).
    2/ To determine the contribution of angiography with ICG during the total thyroidectomy for the identification in vivo and the preservation of parathyroids.
    3/ To assess the contribution of angiography with ICG in the prediction of postoperative hypocalcemia.
    4/ To determine the benefit of angiography with ICG in the prediction of post total thyroidectomy hypoparathyroidism.
    5/ To compare the frequency of postoperative hypocalcemia, according to its grade (mild, moderate, severe), between both groups.
    6/ To assess the tolerance at ICG in patient.
    1/ Evaluer l’apport de l’angiographie au vert d’indocyanine (ICG) dans la modification du taux d’hypoparathyroïdie définitive post thyroïdectomie totale (J8, M1, M6).
    2/ Déterminer l’apport de l’angiographie au vert d’indocyanine (ICG) au cours du geste de thyroïdectomie totale pour le repérage in vivo et la préservation des parathyroïdes.
    3/ Evaluer l’apport de l’angiographie au vert d’indocyanine dans la prédiction de l’hypocalcémie post opératoire
    4/ Déterminer l’intérêt de l’angiographie au vert d’indocyanine (ICG) dans la prédiction de l’hypoparathyroïdie post thyroïdectomie totale
    5/ Comparer la fréquence d’hypocalcémie postopératoire, selon son grade (légère, modérée et profonde), entre le groupe avec utilisation du vert d’indocyanine vs le groupe sans utilisation du vert d’indocyanine.
    6/ Evaluer la tolérance du vert d’indocyanine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient having to undergo a total thyroidectomy
    - Signed consent
    - Patient beneficiary of a social security regimen
    - Patients devant subir une intervention de thyroïdectomie totale
    - Consentement signé
    - Patient bénéficiaire d’un régime de sécurité sociale
    E.4Principal exclusion criteria
    - Minor patient under 18 years old
    - Major patient protected by law or unable to give informed consent
    - Pregnant or breastfeeding woman
    - Thyroidectomy totalization
    - History of thyroid or parathyroid surgery
    - Participation refusal
    - Known allergy to ICG
    - Patients mineurs < 18 ans
    - Majeur protégé ou personne incapable de formuler son consentement à l’étude
    - Femme enceinte et allaitante
    - Totalisation de thyroïdectomie
    - Antécédent chirurgical thyroïdien ou parathyroïdien
    - Refus de participation
    - Réaction allergique connue au vert d’indocyanine (ICG)
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence (yes/no) of hypocalcemia corrected by albumin under or equal to 2 mmol/L in the 48h postoperative.
    Occurrence (oui/non) d’hypocalcémies corrigées par albumine (≤2 mmol/L) dans les 48h postopératoires.
    E.5.1.1Timepoint(s) of evaluation of this end point
    48h postoperative
    48h postopératoire
    E.5.2Secondary end point(s)
    1/ Occurrence (yes/no) of hypocalcemia corrected by albumin under 2 mmol/L at day 8, month 1 and month 6 postoperative.
    2/ Modification (yes/no) of surgical gesture by the improvement of the detection of parathyroids or their vascularisation during total thyroidectomy with angiography with ICG.
    3/ Peroperative vitality score of parathyroids when using angiography with ICG.
    4/ Occurrence (yes/no) of hypoparathormone at Day 1 and Day 2 postopérative (under 10ng/L).
    5/ Occurrence (yes/no) of mild (asymptomatic and >1.7mmol/L), moderate (symptomatic and >1.7mmol/L) and severe (<1.7mmol/L) hypocalcemia in the 48h postoperative
    6/ Occurrence of adverse effect related to injection of ICG
    1/ Occurrence (oui/non) d’hypocalcémie postopératoire corrigée par albumine (<2mmol/L) à J8, M1 et M6
    2/ Modification (oui/non) du geste chirurgical par l’amélioration de la détection des parathyroïdes ou de leur vascularisation au cours de la thyroïdectomie avec l’utilisation de l’angiographie au vert d’indocyanine
    3/ Score de vitalité des parathyroïdes en per-opératoire lors de l’utilisation de l’angiographie au vert d’indocyanine.
    4/ Occurrence (oui/non) d’une hypoPTH à J1 et J2 post-opératoire (<10ng/L)
    5/ Occurrence (oui/non) d’hypocalcémie légère (asymptomatique et >1.7mmol/l), modérée (symptomatique et >1.7mmol/l) et profonde (<1.7mmol/l) dans les 48 heures postopératoires
    6/ Survenue d’un effet indésirable lié à l’injection du vert d’indocyanine.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 0, Day 1, Day 2, Day 8, Month 1 and Month 6 postoperative
    Jour 0, Jour 1, Jour 2, Jour 8, Mois 1 et Mois 6 postopératoire
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    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) 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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    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
    Méthode de référence
    Standard method
    E.8.2.4Number of treatment arms in the trial2
    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.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months8
    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: 181
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 61
    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 state242
    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
    Aucun
    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 Decision2021-02-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-09
    P. End of Trial
    P.End of Trial StatusOngoing
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