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    Summary
    EudraCT Number:2019-003506-26
    Sponsor's Protocol Code Number:CI-331-19
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-01-14
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-003506-26
    A.3Full title of the trial
    Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy
    Determinación de la función paratiroidea mediante fluorescencia con verde de indocianina (ICG) tras tiroidectomía total
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy
    Determinación de la función paratiroidea mediante fluorescencia con verde de indocianina (ICG) tras tiroidectomía total
    A.4.1Sponsor's protocol code numberCI-331-19
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04012476
    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 SponsorHospital Universitari Son Espases
    B.1.3.4CountrySpain
    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 supportHospital Universitari Son Espases
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitari Son Espases
    B.5.2Functional name of contact pointEndocrine Surgery Unit
    B.5.3 Address:
    B.5.3.1Street AddressCarretera de Valldemossa 79
    B.5.3.2Town/ cityPalma de Mallorca
    B.5.3.3Post code07120
    B.5.3.4CountrySpain
    B.5.4Telephone number34871205959
    B.5.6E-mailjaime.bonnin@ssib.es
    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 Verde de Indocianina (Indocyanine Green)
    D.2.1.1.2Name of the Marketing Authorisation holderXalabarder Farma
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameIndocyanine Green
    D.3.4Pharmaceutical form Powder for solution for infusion
    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 INNIndocyanine green
    D.3.9.1CAS number 3599-32-4
    D.3.9.3Other descriptive nameINDOCYANINE GREEN
    D.3.9.4EV Substance CodeSUB14208MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Patients undergoing total thyroidectomy with visualization of the parathyroid glands under infrared light after intraoperative intravenous injection of 5 mg of indocyanine green to predict the possible occurrence of postoperative hypocalcemia
    E.1.1.1Medical condition in easily understood language
    Patients in whom after having removed the thyroid gland the fluorescence of the parathyroid glands is assessed by administering endovenous indocanine green
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10020949
    E.1.2Term Hypocalcemia
    E.1.2System Organ Class 100000004861
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10080819
    E.1.2Term Post procedural hypoparathyroidism
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The intensity of parathyroid fluorescence that occurs after intravenous injection of indocyanine green during the performance of a total thyroidectomy correlates with postoperative parathyroid function and could be used as a diagnostic marker of postoperative hypoparathyroidism and hypocalcemia.
    The main objective of the study is to compare the intensity of parathyroid fluorescence among patients who present post-thyroidectomy hypocalcemia with that of patients who do not have it. Therefore, the following points will be studied:
    • To study the correlation between parathyroid vascularization (intraoperative fluorescence intensity) and postoperative glandular function (serum calcium and parathormone levels).
    • To compare the surgeon's subjective assessment of parathyroid fluorescence, and the objective assessment of parathyroid fluorescence, by using specific computer software developed ad hoc,
    between the groups of patients with and without postoperative hypocalcemia.
    E.2.2Secondary objectives of the trial
    - Predict in real time during the surgical act which patients will not present postoperative parathyroid hypofunction through the use of specific computer software developed ad hoc.
    - Assess statistical relationships between the intensity of parathyroid fluorescence and the demographic, operative and postoperative variables, and of these with the values of PTH and postoperative calcemia.
    - Determine the rate of complications related to the administration of ICG (up to 90 days after surgery)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients who are going to undergo total thyroidectomy, with or without cervical lymph node dissection.
    • Visualization of 2 or more parathyroid glands during the surgical act.
    • Normal renal and hepatic functions.
    • Absence of a history of hypersensitivity reactions to iodine or indocyanine
    green.
    • Able to understand the nature and protocol of the study and its procedures
    • Willingness to participate with the subsequent signing of informed consent
    E.4Principal exclusion criteria
    • Age <18 years
    • Hepatic or renal insufficiency
    • Hypersensitivity to iodine or to indocyanine green.
    • Pregnancy or lactation
    • Inability to understand the nature and procedures of the study. • Patients with known preoperative hyperparathyroidism.
    E.5 End points
    E.5.1Primary end point(s)
    1. Serum calcium level at 24 hours postoperatively
    2. Subjective parathyroid fluorescence:
    Fluorescence intensity of the parathyroid glands after administration of indocyanine green (ICG), measured on a subjective analogue scale (0: no fluorescence, 1: hypofluorescence or heterogeneous fluorescence, 2: homogeneous hyperfluorescence).
    3. Objective parathyroid fluorescence
    Fluorescence intensity of the parathyroid glands after administration of indocyanine green (ICG), measured by specific computer software developed ad hoc.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Day 1 after surgery (24 hours after surgery)
    2. Intraoperatively
    3. Intraoperatively
    E.5.2Secondary end point(s)
    4. Age Patient's age
    5. Sex
    6. Body mass index Patient's BMI
    7. Surgery date
    8. Preoperative diagnosis
    Thyroid pathology indicating total thyroidectomy (thyroid carcinoma, atypical of uncertain significance, goiter or lymphocytic thyroiditis)
    9. Preoperative vitamin D level
    10. Preoperative PTH level
    11. PTH levels 10 minutes post-thyroidectomy
    12. Scope of surgery: total thyroidectomy (TT), TT with central neck dissection, or TT with functional lateral neck dissection
    13. Duration of surgery
    14. Number of parathyroid glands located during surgery,
    15. Location of the parathyroid glands (superior right, inf-right, sup-left, inf-left).
    16. Outcome of thyroid pathology (papillary carcinoma, nodular hyperplasia or lymphocytic thyroiditis)
    17. Thyroid weight Thyroid weight
    18. Presence of parathyroid glands in the surgical piece and number
    19. Stay: Number of days of postoperative hospital stay until the day of hospital discharge, measured as full days of 24 hours
    20. Presence and number of surgical drainages
    21. PTH day 1: PTH levels in the postoperative follow-up,
    22. Complications: Emergence of postoperative complications.
    E.5.2.1Timepoint(s) of evaluation of this end point
    4. Baseline
    5. Baseline
    6. Baseline
    7. Baseline
    8. Baseline
    9. Preoperative blood test
    10.Immediately before surgery
    11. 10 minutes post-thyroidectomy
    12. Inmediately after surgery
    13. Inmediately after surgery
    14. During surgery
    15. During surgery
    16. during the first month after surgery
    17. during the first month after surgery
    18. during the first month after surgery
    19. During the first month after surgery
    20. Inmediately after surgery
    21. Day 1 after surgery
    22. During the first 3 months after surgery
    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 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) 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 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.8.2.4Number 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
    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 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) Yes
    F.1.2.1Number of subjects for this age range: 25
    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 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 state40
    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)
    All patients will be followed in outpatient consultations of the General Surgery and Digestive System Service for up to 90 days to follow up complications (as usual)
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-03-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-15
    P. End of Trial
    P.End of Trial StatusOngoing
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