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    The EU Clinical Trials Register currently displays   44238   clinical trials with a EudraCT protocol, of which   7338   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:2018-004745-17
    Sponsor's Protocol Code Number:UMCG:201800879
    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:2019-01-31
    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 number2018-004745-17
    A.3Full title of the trial
    Detection of Early Esophageal Cancer by Near-Infrared Fluorescence molecular Endoscopy using Bevacizumab-800CW
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Detection of early stages of esophageal cancer with fluorescence molecular endoscopy.
    A.3.2Name or abbreviated title of the trial where available
    Fluorescence endoscopy of early stages of esophageal cancer.
    A.4.1Sponsor's protocol code numberUMCG:201800879
    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 Medical Center Groningen
    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 supportUniversity Medical Center Groningen
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointDepartment of Gastroenterology
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9700 RB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031503612620
    B.5.6E-mailw.b.nagengast@umcg.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-IRDye800CW
    D.3.2Product code Bevacizumab-IRDye800CW
    D.3.4Pharmaceutical form Suspension and solution for spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeconjugate of antibody with a fluorophore
    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 with Barretts esophagus and there is a suspicion for at least low grade dysplasia.
    Patienten met Barrett's slokdarm waarbij een hoge verdenking is op ten minste laag gradige dysplasie.
    E.1.1.1Medical condition in easily understood language
    Barrett's esophagus.
    Barrett slokdarm
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    To evaluate the performance of FME with topical administration of bevacizumab-800CW and/or cetuximab-800CW or ICG for detection of neoplasia in BE patients compared to HD-WLE to make an estimation of the diagnostic accuracy in terms of sensitivity and specificity in order to make a power size calculation for the Phase III trial.
    E.2.2Secondary objectives of the trial
    To collect more safety data of topical administration, by spraying bevacizumab-IRDye800CW and/or cetuximab-800CW or ICG.
    Quantify in vivo the NIR fluorescent signal of Bevacizumab-800CW by means of the MDSFR/SFF spectroscopy probe.
    To evaluate the degree of in vivo fluorescence intensity and ex vivo grade of VEGF and EGFR expression for the different stages of esophageal dysplasia-carcinoma sequence.
    Interrogate new EC targets derived from our recent findings on EC dysplasia targets to further improve EC detection by multi parametric examination and disease stratification over using Bevacizumab-IRDye800CW.
    Eventually further specify and objectify the improvement of NIR-FME leading to reduction of unnecessary biopsies.
    Investigate the improvement of speed, efficiency and quality of the NIR-FME examination.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Suspicion or diagnosed LGD, HGD or superficial EAC and planned diagnostic and/or therapeutic endoscopy.
    Mentally competent person, 18 years or older.
    dequate potential for 5-year follow-up.
    Written informed consent.
    E.4Principal exclusion criteria
    Patients younger than 18 years old
    Submucosal and invasive EAC; EAC with TNM-classification other than T1.
    Radiation therapy for esophageal cancer
    Immunoglobulin allergy
    Chemotherapy, immunotherapy or surgery 28 days before administration of the tracer
    Prior Bevacizumab treatment
    Non-adjustable hypertension
    Medical or psychiatric conditions that compromise the patient’s ability to give informed consent.
    Pregnancy or breast feeding.
    E.5 End points
    E.5.1Primary end point(s)
    - Macroscopic fluorescent signal levels and tracer distribution observed by flexible fluorescence molecular endoscopy.
    - Macroscopic quantification of the fluorescent signal observed by means of the MDSFR/SFF spectroscopy probe.
    - Microscopic distribution and (semi-quantitative) fluorescent signal intensity of bevacizumab-IRDye800CW in the EMR specimen and biopsies correlated to VEGF distribution and level of expression as well as cetuximab-800CW and EGFR distribution and level of expression.
    - Ex-vivo we will perform binding experiments with tracers against GREM1, -SULF1 and –PRKCi on the fresh EMR and surgical EC specimen if available and compare them against the in-vivo WLE/NIR-FME findings. We will analyze the sensitivity and specificity of the novel markers alone or in combination. The targeting moieties will be coupled with different fluorophores allowing for multi-parametric analysis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    An interim analysis will be conducted by the investigators involved in this study after the first 15 patients. The interim analysis will include the primary endpoint as well as key safety parameters.
    E.5.2Secondary end point(s)
    - The correlation between fluorescence intensity and the grade of VEGF expression on immunohistochemistry, in (pre)malignant lesions of the esophagus.
    - Adverse events (AE), serious adverse events (SAE), and suspected unexpected serious adverse reactions (SUSARs).
    Patient characteristics (age, sex, BMI, history and morbidity, presence of GERD, treatment outcome, prior BE diagnosis and classification, blood pressure, oxygen saturation, and temperature during the procedure).
    - EMR specimen and biopsy characteristics (grade of dysplasia or tumor stage, size and/or piecemeal resection, resection margins, presence of metachronous dysplastic lesions)
    - Histopathologic examinations related to ex vivo VEGF expression and bevacizumab-IRDye800CW distribution and ex vivo EGFR expression and cetuximab-800CW distribution.
    E.5.2.1Timepoint(s) of evaluation of this end point
    An interim analysis will be conducted by the investigators involved in this study after the first 15 patients. The interim analysis will include the primary endpoint as well as key safety parameters.
    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 No
    E.6.6Pharmacokinetic Yes
    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 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 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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state75
    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 Decision2019-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-28
    P. End of Trial
    P.End of Trial StatusOngoing
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