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    Summary
    EudraCT Number:2021-006700-32
    Sponsor's Protocol Code Number:80013
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-07-13
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-006700-32
    A.3Full title of the trial
    A pilot study to assess the safety and feasibility of fluorescent sentinel lymph node identification in colon carcinoma using submucosal bevacizumab-800CW.
    Een pilot studie om de veiligheid en haalbaarheid van schildwachtklier identificatie bij patiënten met colon carcinoom middels submucosaal bevacizumab-800CW te beoordelen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Identification of the sentinel lymph node (SLN) in patients with colon carcinoma.
    Identificatie van de schildwachtklier (SWK) bij patienten met dikke darm kanker.
    A.3.2Name or abbreviated title of the trial where available
    IBIZA-1(pilot)
    IBIZA-1(pilot)
    A.4.1Sponsor's protocol code number80013
    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 SponsorMeander Medical Centre
    B.1.3.4CountryNetherlands
    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 supportMeander Medisch Centrum
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMeander Medical Centre
    B.5.2Functional name of contact pointDaan Sikkenk
    B.5.3 Address:
    B.5.3.1Street AddressMaatweg 3
    B.5.3.2Town/ cityAmersfoort
    B.5.3.3Post code3813 TZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031338501268
    B.5.6E-maildj.sikkenk@meandermc.nl
    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.2.5The 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 namebevacizumab-800CW
    D.3.2Product code bevacizumab-800CW
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubmucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBevacizumab-800CW
    D.3.9.2Current sponsor codeMeander Medical Centre
    D.3.9.3Other descriptive nameBEVACIZUMAB-IRDye 800CW
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    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
    Colon carcinoma
    Colon carcinoom
    E.1.1.1Medical condition in easily understood language
    Large bowel cancer
    Dikke darm kanker
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
    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
    Assess safety and feasibility of SLN identification using submucosal peritumoral bevacizumab-800CW injections. Defined as:
    1. Identification rate of SLN(s) or lymph node metastases with bevacizumab-800CW, Defined as the number of patients in which a SLN or lymph node metastases were detected due to fluorescence during surgery and/or pathology assessment / total number of procedure
    2. Rate of adverse events related to bevacizumab-800CW (injection).
    Defined as the number of adverse events related towards bevacizumab-800CW / total number of procedures (n, %).
    Het bepalen van veiligheid en haalbaarheid van SWK identificatie, met behulp van peri-tumorale bevacizumab-800CW injectie. Gedefinieerd als:
    1. Percentage SLN detectie middels bevacizumab-800CW.
    2. Complicaties gerelateerd aan bevacizumab-800CW (injectie).
    E.2.2Secondary objectives of the trial
    1. Amount of fluorescence in lymph node metastases compared to lymph node without metastases
    2. False-negative SLNs: The SLNs are negative whereas the non-sentinel nodes (NSNs) were positive (number).
    3. True-negative SLNs: Both the SLNs and NSNs are negative (number).
    4. Sensitivity: The number of patients with a positive SLN / the total number of node positive patients (n, %).
    5. Upstaging: The number of patients with SLNs positive after ultrastaging / the number of patients who were node negative by H&E examination (n, %).
    6. Aberrant lymph node status: The number of patients with aberrant lymph nodes, and the status of these lymph nodes
    7. Accuracy: (The total number of patients with a positive SLN + the number of patients with a true-negative SLN) / number of patients with an identified SLN (n, %).
    8. Negative predictive value (NPV): The number of true negative SLNs / (true negative + false negative SLNs).
    9. Number of SLN identified
    1. Hoeveelheid fluorescentie in lymfeklieren met metastasen vergeleken lymfeklieren zonder metastasen.
    2. False-negative SLNs: De SLN is negatief terwijl de non-SLN positief is.
    3. True-negative SLNs: de SLN en de non-SLN zijn beide negatief
    4. Sensitiviteit: Aantal patiënten met een positieve SLN / total aantal patiënten met lymfekliermetastasen
    5. Upstaging: aantal patiënten met een positieve SLN na ultrastaging / totaal aantal patiënten.
    6. Aberrant lymfeklier status: aantal patiënten met een aberrante lymfeklier en de status ervan.
    7. Accuratesse: (totaal aantal patiënten met een positieve SLN + aantal patiënten met een true-negative SLN) / aantal patiënten met een SLN
    8. Negatief voorspellende waarde (NPV): aantal patiënten met een true-negative SLN / (true-negative + false-negative SLN)
    9. Aantal geïdentificeerde SLNs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Oral and written informed consent (IC)
    - Aged 18 years and older
    - Pathologically confirmed and/or suspected cT1-3N0-2M0 colon carcinoma
    - Mondelinge en schriftelijke informed consent (IC)
    - 18 jaar en ouder
    - Pathologisch bevestigd en/of verdenking op colon carcinoom
    E.4Principal exclusion criteria
    - Distant metastasis
    - Suspicion of cT4 disease based on pre-operative assessment
    - Metastatic or T4 disease discovered during intraoperative staging
    - Pregnancy, lactation or a planned pregnancy during the course of the
    study
    - Previous colon surgery, excluding appendectomy.
    - Contra-indication for laparoscopic/robotic surgery
    - Inadequately controlled hypertension with or without current antihypertensive medication.
    - Within 6 months prior to inclusion: myocardial infarction, TIA, CVA, pulmonary embolism, unstable angina pectoris, or uncontrolled chronic hepatic failure.
    - Regarding bevacizumab: Hypersensitivity to Chinese Hamster Ovary
    (CHO) cell products or other recombinant human or humanised
    antibodies. Or an allergy for its components (Trehalose dehydrate,
    sodium phosphate, polysorbate 20, water for injections)
    - Metastasen op afstand
    - Verdenking van cT4 ziekte gebaseerd op preoperatieve onderzoek
    - Metastasen of T4 ziekte ontdekt tijdens de operatie.
    - Zwanger, geplande zwangerschap of borstvoeding gedurende het
    onderzoek.
    - Eerdere operatie van het colon, exclusief appendectomie.
    - Contra-indicatie voor laparoscopie of robot chirurgie.
    - Inadequaat behandelde hypertensie, met of zonder medicatie
    - In de afgelopen 6 maanden: myocardinfarct, TIA, CVA, longembolie, instabiele angina pectoris, ongecontroleerde chronisch leverfalen.
    - Betreffende bevacizumab: overgevoeligheid voor Chinese Hamster
    Ovary (CHO) cell producten, andere recombinante humane of
    gehumaniseerde antilichamen. Of een allergie voor de bestandsdelen
    (Trehalose-dehydraat, natriumfosfaat, polysorbaat 20, water voor
    injecties).
    E.5 End points
    E.5.1Primary end point(s)
    - Identification rate of SLN with bevacizumab-800CW
    - Number of adverse or allergic reactions towards bevacizumab-800CW
    - Identificatie ratio van SWK met bevacizumab-800CW
    - Aantal bijwerkingen of allergische reacties tegen bevacizumab-800CW
    E.5.1.1Timepoint(s) of evaluation of this end point
    Identification ration will be assesed intra-operatively
    Number of adverse/allergic events will be assessed intra and post-operatively
    Identificatie ratio wordt intra-operatief bepaald
    Aantal bijwerkingen/allergische reacties worden intra- en post operatief bepaald.
    E.5.2Secondary end point(s)
    1. Amount of fluorescence in lymph node metastases compared to lymph node without metastases
    2. False-negative SLNs: The SLNs are negative whereas the non-sentinel nodes (NSNs) were positive (number).
    3. True-negative SLNs: Both the SLNs and NSNs are negative (number).
    4. Sensitivity: The number of patients with a positive SLN / the total number of node positive patients (n, %).
    5. Upstaging: The number of patients with SLNs positive after ultrastaging / the number of patients who were node negative by H&E examination (n, %).
    6. Aberrant lymph node status: The number of patients with aberrant lymph nodes, and the status of these lymph nodes
    7. Accuracy: (The total number of patients with a positive SLN + the number of patients with a true-negative SLN) / number of patients with an identified SLN (n, %).
    8. Negative predictive value (NPV): The number of true negative SLNs / (true negative + false negative SLNs).
    9. Number of SLN identified
    1. Hoeveelheid fluorescentie in lymfeklieren met metastasen vergeleken lymfeklieren zonder metastasen.
    2. False-negative SLNs: De SLN is negatief terwijl de non-SLN positief is.
    3. True-negative SLNs: de SLN en de non-SLN zijn beide negatief
    4. Sensitiviteit: Aantal patiënten met een positieve SLN / total aantal patiënten met lymfekliermetastasen
    5. Upstaging: aantal patiënten met een positieve SLN na ultrastaging / totaal aantal patiënten.
    6. Aberrant lymfeklier status: aantal patiënten met een aberrante lymfeklier en de status ervan.
    7. Accuratesse: (totaal aantal patiënten met een positieve SLN + aantal patiënten met een true-negative SLN) / aantal patiënten met een SLN
    8. Negatief voorspellende waarde (NPV): aantal patiënten met een true-negative SLN / (true-negative + false-negative SLN)
    9. Aantal geïdentificeerde SLNs
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints will be collected postoperatively, after pathological assessment is completed.
    Alle secundaire eindpunten worden postoperatief gedaan, nadat de pathologie is uitgevoerd.
    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) 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 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 Yes
    E.8.1.7.1Other trial design description
    Open cohort, veiligheid haalbaarheid
    Open cohort, safety and feasibility
    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
    End of the trial is after pathological assessment of all 10 patients.
    Het einde van de trial is indien pathologische analyse is gedaan bij alle 10 patienten.
    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 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: 2
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 3
    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 state5
    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)
    Treatment after ending the participation of the trial will be the same as standard of care.
    Behandeling van patiënten na participatie in de studie is hetzelfde als standaardzorg.
    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 Decision2022-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-12
    P. End of Trial
    P.End of Trial StatusOngoing
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