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    Summary
    EudraCT Number:2017-002604-27
    Sponsor's Protocol Code Number:PCT2017-1
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-07-10
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-002604-27
    A.3Full title of the trial
    Phase II trial: RGD PET/MRI in sporadic Vestibular Schwannoma
    Kan tumorvækst forudsiges ved RGD-PET/MR af vestibularis schwannomer?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II trial: RGD PET/MRI in sporadic Vestibular Schwannoma
    Kan tumorvækst forudsiges ved RGD-PET/MR af vestibularis schwannomer?
    A.4.1Sponsor's protocol code numberPCT2017-1
    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 Clinical Physiology, Nuclear Medicin and PET
    B.1.3.4CountryDenmark
    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 supportRigshospitalet, Copenhagen University Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigshospitalet, Department of Otorhinolaryngology, Head and Neck Surgery & Audiology
    B.5.2Functional name of contact pointHjalte Christian Reeberg Sass
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9, KF 2071
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number004531310730
    B.5.5Fax number004535458249
    B.5.6E-mailHjalte.christian.reeberg.sass.01@regionh.dk
    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 name68Ga-NODAGA-E[c(RGDyK)]2
    D.3.2Product code 68Ga-NODAGA-ENo p[c(RGDyK)]2
    D.3.4Pharmaceutical form Concentrate and solvent 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 INN68Ga-NODAGA-E[c(RGDyK)]2
    D.3.9.2Current sponsor code68Ga-NODAGA-E[c(RGDyK)]2
    D.3.9.3Other descriptive name68GA-NODAGA-RGD
    D.3.9.4EV Substance CodeSUB130779
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number70
    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 Yes
    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
    Vestibularis Schwannoma
    E.1.1.1Medical condition in easily understood language
    Vestibularis Schwannoma
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10048925
    E.1.2Term Acoustic schwannoma
    E.1.2System Organ Class 100000014065
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objektive of this study is to test whether the new radio tracer 68Ga-NODAGA-E[c(RGDyK)]2 for PET imaging of angiogenises. The tracer combined with PET-MR has the potential to provide a novel non-invasive prognostic method for the growth rate of vestibularis schwannomas, as the growth rate of vestibularis schwannomas has been correlated with pro-angiogenetic markers.
    This is a phase II trial in patients with a benign intracranial tumor. Uptake of the tracer will be correlated to the growth rate by PET-MR and MR scans.
    E.2.2Secondary objectives of the trial
    Tumor uptake of 68Ga-NODAGA-E[c(RGDyK)]2 will be compared to the expression of pro-angiogenetic marker using RNA sequencing in tumor tissue obtained from operative removal of the tumor.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients who are either newly diagnosed with a MR-confirmed vestibularis schwannoma or patients who have been in the wactfull waiting regime for under 12 month and have only received 1 controlscan. The patients must be capable of understanding and giving informed written consent.
    E.4Principal exclusion criteria
    • Pregnancy
    • Non-MR compatible implants
    • Lactation
    • claustrofobi
    • Hormone treatment incl. birthcontrol pills
    • Steroid treatment
    • Obesity (> 140 kg)
    • Known allergy to the PET-tracer 68Ga-NODAGA-E[c(RGDyK)]2
    E.5 End points
    E.5.1Primary end point(s)
    The correlation between the quantative tumor uptake of the PET-tracer 68Ga-NODAGA-E[c(RGDyK)]2 and the tumors growth rate decided by an additional MR-scan minimum 2 month later.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The patients will undergo a PET/MR-scan and an additional MR-scan minimum 2 month after the PET/MR-scan. These timepoints will be used to determine the tumoruptake as well as the growth rate.
    E.5.2Secondary end point(s)
    The correlation between the quantative tumor uptake of the PET-tracer 68Ga-NODAGA-E[c(RGDyK)]2 and the expression of pro-angiogenetic markers via RNA sequencing.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The correlation between the tumoruptake and the expression of the pro-angiogenetic markers. The time points is the PET/MR-scan as well as the RNA sequencing of the tumortissue obtained from surgery.
    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 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 years3
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 Yes
    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)
    They will resume the national treatment regime according to their symptoms.
    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 Decision2017-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-03-16
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