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    The EU Clinical Trials Register currently displays   42312   clinical trials with a EudraCT protocol, of which   6968   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2018-001224-19
    Sponsor's Protocol Code Number:1/0196/16
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-12-07
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2018-001224-19
    A.3Full title of the trial
    Non-invasive in-vivo prediction of therapeutic response to inhibitors of angiogenesis using gallium (68Ga) NODAGA-RGD PET/CT
    Neinvazívna in-vivo predikcia odpovede na terapiu inhibítormi angiogenézy pomocou PET/CT s gálium (68Ga) NODAGA-RGD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Non-invasive in-vivo prediction of therapeutic response to inhibitors of angiogenesis using gallium (68Ga) NODAGA-RGD PET/CT
    Neinvazívna in-vivo predikcia odpovede na terapiu inhibítormi angiogenézy pomocou PET/CT s gálium (68Ga) NODAGA-RGD
    A.3.2Name or abbreviated title of the trial where available
    Angio PET
    Angio PET
    A.4.1Sponsor's protocol code number1/0196/16
    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 SponsorLekárska fakulta Univerzity Komenského v Bratislave
    B.1.3.4CountrySlovakia
    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 supportFaculty of Medicine in Bratislava of Comenius University in Bratislava
    B.4.2CountrySlovakia
    B.4.1Name of organisation providing supportScientific Grant Agency of the Ministry of Education, science, research and sport of the Slovak Republic
    B.4.2CountrySlovakia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFaculty of Medicine in Bratislava of Comenius University in Bratislava
    B.5.2Functional name of contact pointDepartment of Nuclear Medicine
    B.5.3 Address:
    B.5.3.1Street AddressHeydukova 10
    B.5.3.2Town/ cityBratislava
    B.5.3.3Post code81250
    B.5.3.4CountrySlovakia
    B.5.4Telephone number+421232249129
    B.5.5Fax number+421232249131
    B.5.6E-mailsona.balogova@ousa.sk
    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 nameIASON RGD 20 MBq/mL, solution for injection
    D.3.4Pharmaceutical form 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 INNgallium (68Ga) NODAGA-RGD
    D.3.9.3Other descriptive name68GA-NODAGA-RGD
    D.3.9.4EV Substance CodeSUB130779
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Advanced metastatic cancer of the colon or rectum
    Pokročilý metastatický karcinóm hrubého čreva alebo konečníka
    E.1.1.1Medical condition in easily understood language
    Advanced metastatic cancer of the colon or rectum
    Pokročilý metastatický karcinóm hrubého čreva alebo konečníka
    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 PT
    E.1.2Classification code 10009956
    E.1.2Term Colon cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10055114
    E.1.2Term Colon cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10010035
    E.1.2Term Colorectal cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    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
    1. To compare the response rate to treatment including antiangiogenic agent in patients with advanced metastatic cancer of the colon or rectum , according to whether or not all known lesions, were visually positive on gallium (68Ga) NODAGA-RGD PET/CT before starting treatment including antiangiogenic agent
    1. Porovnať frekvenciu odpovede na liečbu zahŕňajúcu liek s antiangiogénnym účinkom u pacientov s pokročilým metastatickým karcinómom hrubého čreva alebo konečníka, podľa toho, či boli všetky známe lézie vizuálne pozitívne na PET/CT s gálium (68Ga) NODAGA-RGD pred iniciáciou liečby zahŕňajúcej liek s antiangiogénnym účinkom
    E.2.2Secondary objectives of the trial
    1. To validate and improve the interpretation criteria for gallium (68Ga) NODAGA-RGD PET/CT

    2. To check the perfect tolerability of gallium (68Ga) NODAGA-RGD
    1. Validovať a optimalizovať interpretačné kritériá pre PET/CT s gálium (68Ga) NODAGA-RGD

    2. Overiť výbornú toleranciu gálium (68Ga) NODAGA-RGD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, all individual must meet all of the following criteria:
    1. Male or female over 18 years of age with histologicaly confirmed metastatic cancer of the colon or rectum fulfilling the following criteria :
    a) Scheduled for treatment including antiangiogenic agent
    b) At least one measurable lesions according to RECIST 1.1 criteria (>10mm in long axis for non-lymph node lesions and >15mm in short axis for lymph node lesions).
    c) Availability of following examination data in DICOM III format performed less than 31 days prior inclusion:
    - Diagnostic CT of thorax, abdomen and pelvis
    - Fludeoxyglucose (18F) PET/CT
    2. Capable of staying still in lying position for the duration of the PET/CT acquisition which can last up to 30 min in all, a "whole body" acquisition
    3. ECOG performance status ≤ 2 at inclusion
    4. Patient with a life expectancy ≥ 24 weeks from baseline
    5. For women of childbearing age, the possibility of pregnancy should be ruled out at inclusion
    6. Volunteer and able to follow the instructions necessary for the study
    7. Having signed an informed consent to participate in the study
    Na zaradenie do tejto štúdie musí každý jednotlivec spĺňať všetky nasledovné kritériá:
    1. Muž alebo žena staršia ako 18 rokov s histologicky potvrdeným pokročilým metastatickým karcinómom hrubého čreva alebo konečníka spĺňajúcim nasledovné kritériá:
    a) Plánovaná na liečba zahŕňajúca inhibítor angiogenézy
    b) Aspoň jedna merateľná lézia podľa kritérií RECIST 1.1 (> 10 mm v dlhej osi pre lézie mimo lymfatických uzlín a> 15 mm v krátkej osi pre uzlinové lézie).
    c) Dostupnosť nasledujúcich údajov o vyšetrení vo formáte DICOM III vykonaných menej ako 31 dní pred zaradením:
    - CT hrudníka, brucha a panvy
    - PET/CT s fludeoxyglukózou (18F)
    2. Pacient schopný zostať v ležiacej polohe počas snímania obrazov PET/CT, čo môže trvať do 30 minút pre celotelové snímanie
    3. Stav výkonnosti ECOG ≤ 2 pri zaradení do štúdie
    4. Pacient s očakávanou dĺžkou života ≥ 24 týždňov od zaradenia do štúdie
    5. U žien vo fertilnom veku sa má pri začlenení vylúčiť možnosť tehotenstva
    6. Pacient ochotný a schopný dodržať pokyny potrebné pre realizáciu štúdie
    7. Podpis informovaného súhlasu s účasťou na štúdii
    E.4Principal exclusion criteria
    An individual who meets any of the following criteria will be excluded from participation in this study:
    - Pregnancy or lactation
    - Known allergy to components of the study product
    - Treatment scheduled does not include antiangiogenic agent
    - Life expectancy less than 6 months
    - ECOG Performance Status >2 or Karnofsky Performance Status <50%
    Jednotlivec spĺňajúci niektoré z nasledujúcich kritérií bude vylúčený z účasti na tejto štúdii:
    - Tehotenstvo alebo laktácia
    - Známa alergia na niektorú zo zložiek skúmaného produktu
    - Plánovaná liečba nezahŕňa liek s antiangiogénnym účinkom
    - Očakávaná dĺžka života je kratšia ako 6 mesiacov
    - Stav výkonnosti ECOG> 2 alebo stav výkonnosti Karnofsky <50%
    E.5 End points
    E.5.1Primary end point(s)
    1. Assessment of value of gallium (68Ga) NODAGA-RGD PET/CT to predict the response to treatment including antiangiogenic agent
    2. Stanovenie prediktívnej hodnoty PET/CT s gálium (68Ga) NODAGA-RGD pre odpoveď na liečbu zahŕňajúcu liek s antiangiogénnym účinkom
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after gallium (68Ga) NODAGA-FGD and at least two cycles of treatment including antiangiogenic agent.
    6 mesiacov po PET/CT s gálium (68Ga) NODAGA-RGD a po minimálne dvoch cykloch liečby zahŕňajúcej liek s antiangiogénnym účinkom
    E.5.2Secondary end point(s)
    1. Refinement of criteria for interpretation of gallium (68Ga) NODAGA-RGD PET/CT

    2. Confirmation of perfect tolerability of gallium (68Ga) NODAGA-RGD
    1. Optimalizácia interpretačných kritérií pre PET/CT s gálium (68Ga) NODAGA-RGD

    2. Potvrdenie výbornej tolerancie gálium (68Ga) NODAGA-RGD

    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 6 months after gallium (68Ga) NODAGA-RGD and at least two cycles of treatment including antiangiogenic agent.

    2. During, immediately after and up to 24 after administration of gallium (68Ga) NODAGA-RGD
    1. 6 mesiacov po PET/CT s gálium (68Ga) NODAGA-RGD a po minimálne dvoch cykloch liečby zahŕňajúcej liek s antiangiogénnym účinkom

    2. Počas, bezprostredne po a do 24 hodín po podaní gálium (68Ga) NODAGA-RGD
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 state76
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 76
    F.4.2.2In the whole clinical trial 76
    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)
    Not different from the expected normal treatment of given condition.
    Nie je odlišná od očkávanej bežnej liečby pri danom ochorenií.
    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 Decision2019-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-14
    P. End of Trial
    P.End of Trial StatusOngoing
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