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    Summary
    EudraCT Number:2021-002449-13
    Sponsor's Protocol Code Number:S65525
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-07-02
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-002449-13
    A.3Full title of the trial
    Visualisation of Indocyanine Green in Primary and Interval Debulking for Ovarian Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Visualisation of Indocyanine Green in Primary and Interval Debulking for Ovarian Cancer
    Visualisatie van indocyanine groen bij primaire en interval debulking bij eierstokkanker
    A.3.2Name or abbreviated title of the trial where available
    VIPIDO
    VIPIDO
    A.4.1Sponsor's protocol code numberS65525
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04891185
    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 SponsorUniversity Hospitals Leuven (UZ Leuven)
    B.1.3.4CountryBelgium
    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 supportUniversity Hospitals Leuven (UZ Leuven)
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospitals Leuven (UZ Leuven)
    B.5.2Functional name of contact pointCoordinating Investigator
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat 49
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.4Telephone number32016344750
    B.5.6E-mailtoon.vangorp@uzleuven.be
    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 Verdye
    D.2.1.1.2Name of the Marketing Authorisation holderDiagnostic Green GmbH
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 for solution 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 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
    Advanced stage high-grade serous epithelial ovarian cancer: FIGO stage IIIb, IIIc and IV
    E.1.1.1Medical condition in easily understood language
    Advanced stage ovarian cancer
    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 10033128
    E.1.2Term Ovarian cancer
    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
    Determine the diagnostic accuracy of ICG in visualising peritoneal lesions of EOC in vivo.
    E.2.2Secondary objectives of the trial
    - Obtaining the false positive and false negative rate of in vivo ICG fluorescence signal.
    - Determine the difference of estimated ICG uptake in vivo of peritoneal lesions between primary debulking and interval debulking.
    - Correlation between the pre-operative radiographic examination(s) and the ICG signal in vivo and the pathological examination.
    - Determination of the tumour-to-background ratio of fluorescence in peritoneal lesions, lymph nodes and other anatomical structures.
    - Assessment of the number and type of adverse effects, severe adverse effects and adverse reactions with the trial dose of the IMP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
    2. At least 18 years of age.
    3. Advanced stage epithelial ovarian cancer: FIGO stage IIIb, IIIc or IV. (For FIGO staging classification, please refer to Appendix 7).
    4. A biopsy or cytology confirming the presence of high-grade serous epithelial ovarian carcinoma
    5. Preoperative imaging (CT and/or MRI), describing metastatic implants, as standard of care.
    E.4Principal exclusion criteria
    1. Participant has a history of following diseases:
    a. Hyperthyroidism
    b. Autonomously functioning thyroid adenoma
    2. Participant has an allergy or hypersensitivity for one or more of the following components:
    a. Iodine (including potassium iodine)
    b. Indocyanine green
    3. Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol.
    4. Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial.
    5. Participation in an interventional Trial with an investigational medicinal product (IMP) or device during the surgery itself.
    6. Participant has a severe renal impairment (classified as eGFR<30 ml/min/1,73m2 according to CKD-EPI).
    7. Participant utilises sodium bisulfite-containing heparin preparations during the day before surgery. For Belgian registered drugs, this contains:
    a. Danaparoïde (Orgaran®)
    b. Other low-molecular weight heparins registered in Belgium do not contain sodium bisulfite and are not an exclusion criterion.
    8. Participants requires thyroid scintigraphy utilising radioactive iodine one week after surgery.
    9. A previous history of major intra-abdominal surgery with potentially major adhesions and/or distorted anatomy.
    10. Participants utilises one of the interacting drugs listed in the protocol
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this Trial is to determine the diagnostic accuracy of ICG in visualising peritoneal lesions of EOC in vivo. By using the NIR fluorescence camera, peritoneal malignant implants should be fluorescent after intravenous injection of ICG. Benign lesions should not be fluorescent after intravenous injection of ICG.
    E.5.1.1Timepoint(s) of evaluation of this end point
    When 10 participants have been included in a Trial arm (i.e., in either the primary debulking group or the interval debulking group), an interim analysis will be conducted in this arm. Only the primary endpoint (i.e., whether ICG is capable to correctly visualise peritoneal lesions of EOC in vivo) will be used for the interim analysis.
    E.5.2Secondary end point(s)
    • Obtaining the false positive and false negative rate of in vivo ICG fluorescence signal by correlating these results with the pathological report.
    • Determine the difference of estimated ICG uptake in vivo of peritoneal lesions between primary debulking and interval debulking.
    • Correlation between the pre-operative radiographic examination(s) and the ICG signal in vivo and the pathological examination.
    • Determination of the tumour-to-background ratio of fluorescence in peritoneal lesions, lymph nodes and other anatomical structures. Correlation of this ratio with the pathological examination.
    • Assessment of the number and type of adverse effects, severe adverse effects and adverse reactions with the trial dose of the IMP.
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A, no secondary endopoint evaluation, only when Trial is concluded
    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 Yes
    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) 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 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
    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 months0
    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 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 Information not present in EudraCT
    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)
    None
    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 Decision2021-07-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-10-01
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