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    Summary
    EudraCT Number:2013-005565-40
    Sponsor's Protocol Code Number:OTP-B-Linköping
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-02-17
    Trial results View 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 ConcernedSweden - MPA
    A.2EudraCT number2013-005565-40
    A.3Full title of the trial
    Optical measurement with 5-ALA during surgical resection of brain tumors in children
    Optisk mätning med 5-ALA vid kirurgisk resektion av hjärntumör hos barn
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Light measurements during brain tumor operation in children
    Ljusmätning vid hjärntumörkirurgi hos barn
    A.3.2Name or abbreviated title of the trial where available
    OTP-Children
    OTP-Barn
    A.4.1Sponsor's protocol code numberOTP-B-Linköping
    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 SponsorDepartment of Biomedical Engineering, Linköping University
    B.1.3.4CountrySweden
    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 supportBarncancerfonden
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Biomedical Engineering
    B.5.2Functional name of contact pointLinköping University
    B.5.3 Address:
    B.5.3.1Street AddressUniversity Hospital
    B.5.3.2Town/ cityLinköping
    B.5.3.3Post code581 85
    B.5.3.4CountrySweden
    B.5.4Telephone number46101032488
    B.5.6E-mailneda.haj.hosseini@liu.se
    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 Gliolan
    D.2.1.1.2Name of the Marketing Authorisation holderMedac Gesellschaft Klinische Spezialpräparate GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameGliolan
    D.3.4Pharmaceutical form Concentrate for oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOther use (Noncurrent)
    Oral use
    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 Yes
    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
    Tumour border by means of fluorescenstechnique during surgical resection of brain tumours.
    Tumörgräns med hjälp av fluorescensteknik under operation av hjärntumör.
    E.1.1.1Medical condition in easily understood language
    Brain tumour operation.
    Hjärntumöroperation.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    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
    Improve brain tumour resection in children.



    Förbättra hjärntumörresektion hos barn.
    E.2.2Secondary objectives of the trial
    Use fluorescence techniques (imaging and point measurements) for finding tumour border during resection. Compare fluorescence recordings in the microscope and point measurements with histology and other imaging techniques used (e.g. MRI, ultrasound), and naked eye assessment by the surgeon.
    Använda fluorescenstekniker (avbildning och punktmätning) för att finna tumörgräns. Jämföra fluorescensmätning med mikroskopi och punktmätning med histologi, andra avbildande tekniker (tex. MRI, ultraljud) och kirurgens visuella avläsning.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 3-17 years.
    Planned or acute brain tumour surgery.
    Patiens with new radiologal findings of infiltative infra- and supratentorial brain tumours.
    3-17 år.
    Planerad eller akut hjärntumörkirurgi.
    Patienter med radiologiskt nyupptäckt infiltrativa och infra- och supratentoriella hjärntumörer
    E.4Principal exclusion criteria
    Oversensitivity to 5-ALA or porphyria
    Acute or chronic porphyria
    Pregnacy
    Breast feeding
    Liver, kidney and bloodvalues deviation more than +/-10% from reference values before surgery.
    Överkänslighet mot 5-ALA eller mot porfyriner.
    Akuta eller kroniska typer av porfyri.
    Graviditet
    Amning
    Labprover på leverfunktion, njurfunktion och blodvärden tagna före operationen som avviker mer än +/-10% från gällande referensvärden innan kirurgi
    E.5 End points
    E.5.1Primary end point(s)
    The fluorescense microscopy increase the possibility to identify the tumour margins during tumour resection. The probe technology detect weak fluorescence better than the microscope in the tumour and tumour border zone.
    Fluorescensmikroskopet ökar kirurgens möjlighet att se tumören vid operationen. Probtekniken detektera svag fluorescens bättre än mikroskopet i tumör och tumörgräns.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During surgery.
    Under kirurgin.
    E.5.2Secondary end point(s)
    The fluorescens intensity recorded by the probe is objectified and calculated as a number displaying the strength. The number is especially helpful in the borderzon, compared to the microscope. The fluorescence strength and the biopsy results agree and can be devided into groups representing different tissue types. The resected volume as calculated from the MRI is related to the clinical outcome of the operation.
    Fluorescenssignalen från proben kan objektifieras genom att ett värde motsvarande styrkan i fluorescensen beräknas. Detta värde är tydligare i tumörens randzon jämfört med fluorescensen från mikroskopibilden. Biopsiresultat och fluorescensensstyrka överensstämmer och kan indelas i grupper som motsvarar olika vävnader. Den borttagna tumörvolymen som beräknas från MRI relateras till det kliniska resultatet.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Postoperatively within three months after surgery.
    Postoperativt, inom tre månader efter genomförd kirurgi.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    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 Yes
    E.6.13.1Other scope of the trial description
    Tumour border identification during sugical resection
    Identifiering av tumörgräns vid kirurgisk resektion
    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.8.2.4Number 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 last subject.
    Sista besöket för sista patienten
    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 months6
    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 Yes
    F.1.1Number of subjects for this age range: 20
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-02-17. Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Written informed concent from two care givers plus the patient.
    In an emergency situation it might not be possible to recieve written concent from the patient.
    Två vårdnads havare ger informerat skriftligt tillstånd tillsammans med tillstånd från patienten.
    I fall av akutkirurgi kan tillfälle förekomma där patienten inte kan ge eget tillstånd.
    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)
    Routine care according to general practice.
    Rutinomhädertagande enligt gängse paxis.
    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 Decision2014-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-28
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