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    Summary
    EudraCT Number:2020-003932-26
    Sponsor's Protocol Code Number:Ga-68-CCK2R
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-12-01
    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 ConcernedAustria - BASG
    A.2EudraCT number2020-003932-26
    A.3Full title of the trial
    Phase I/IIa study to evaluate the safety, tolerability, whole-body distribution, and preliminary diagnostic performance of a novel 68Ga-labelled minigastrin analogue in patients with advanced neuroendocrine tumours
    Phase I/IIa Studie zur Evaluierung der Sicherheit, Verträglichkeit, Ganzkörperverteilung, sowie der diagnostischen Möglichkeiten eines neuartigen 68Ga-markierten Minigastrin-Analogons bei Patienten mit fortgeschrittenen neuroendokrinen Tumoren
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Minigastrin derivative labelled with radioactive Gallium-68, for the diagnosis of advanced neuroendocrine tumours
    A.4.1Sponsor's protocol code numberGa-68-CCK2R
    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 SponsorMedizinische Universität Innsbruck
    B.1.3.4CountryAustria
    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 supportMedizinische Universität Innsbruck
    B.4.2CountryAustria
    B.4.1Name of organisation providing supportLandeskrankenhaus Innsbruck - Tirol Kliniken
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinik für Nuklearmedizin
    B.5.2Functional name of contact pointChefsekretariat
    B.5.3 Address:
    B.5.3.1Street AddressAnichstraße 35
    B.5.3.2Town/ cityInnsbruck
    B.5.3.3Post code6020
    B.5.3.4CountryAustria
    B.5.4Telephone number004351250422651
    B.5.5Fax number004351250422659
    B.5.6E-mailstudyoffice-nuclearmedicineInnsbruck@i-med.ac.at
    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-DOTA-MGS5
    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 INN68Ga-DOTA-MGS5
    D.3.9.2Current sponsor code68Ga-DOTA-MGS5
    D.3.9.3Other descriptive nameradiolabelled peptide analogue targeting CCK2 receptors
    D.3.9.4EV Substance CodeSUB120977
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number111 to 222
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOTA-MGS5
    D.3.9.2Current sponsor codeDOTA-MGS5
    D.3.9.3Other descriptive namechemical precursor for radiopharmaceutical preparation
    D.3.9.4EV Substance CodeSUB120977
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 neuroendocrine tumours (NET), including medullary thyroid carcinoma (MTC), as well as gastroenteropancreatic and bronchopulmonary NET
    E.1.1.1Medical condition in easily understood language
    Metastatic cancer originating from neuroendocrine cells of the thyroid (medullary thyroid cancer) as well as of the lung or gastrointestinal tract
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Clinical safety and tolerability of intravenous administration of 68Ga-DOTA-MGS5
    - Whole-body distribution and dosimetry
    E.2.2Secondary objectives of the trial
    - Preliminary targeting properties of 68Ga-DOTA-MGS5 in patient with advanced MTC and other NET
    - Comparison of the targeting properties with other standard imaging modalities (18F-DOPA-PET/CT or 68Ga-SSTR-PET/CT including a contrast enhanced CT performed up to six months before study inclusion)
    - Description of the overall, positive and negative agreement on a lesion-bylesion basis as well as on a patient basis of 68Ga-DOTA-MGS5 PET/CT (low dose CT) relative to the standard imaging procedures overall and for each tumour type
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - ≥18 years, men and women
    - Understanding and provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures
    - Karnofsky performance status >70
    - Histopathologically diagnosed locally advanced or metastatic MTC with calcitonin level >100 pg/mL after total thyroidectomy or other histologically
    diagnosed gastroenteropancreatic and bronchopulmonary NET with known metastases
    - Patients with an advanced stage of disease as documented by local or distant metastasis in alternative imaging procedure such as 68Ga-SSTR-PET/CT or 18FDOPA-PET/CT, including a contrast enhanced CT performed up to six months before study inclusion
    - Male subjects must-agree to use condoms throughout the study period and for 1 month after study termination if their partner is of childbearing potential and is using no contraception. They agree not to donate semen during the study period and for 1 month after study termination.
    - Women of childbearing potential (WOCBP) must have a negative urine/serum pregnancy test. WOCBP who are sexually active, agree to use highly-effective means of contraception during the study period and for at least 6 months poststudy treatment. Allowed are accepted and effective non-hormonal methods of contraception and sexual abstinence or vasectomised partners (>3 months previously). Vasectomy has to be confirmed by two negative semen analyses.
    E.4Principal exclusion criteria
    - Other known co-existing malignancies except patients with a history of malignant tumours in complete remission >3 years, with no evidence of recurrence <5 years
    - Participation in any other investigational trial within 3 months of study entry
    - Treatment with tyrosine kinase inhibitors within 1 month before study entry
    - Organ allograft requiring immunosuppressive therapy
    - Renal insufficiency with an eGFR <30 mL/min/1.72m2
    - Higher than grade 2 hematotoxicity (CTC >2)
    - Clinically abnormal ECG (signs of ischemia, high grade ventricular arrhythmia, high grade supraventricular arrhythmia)
    - Pregnancy, breast-feeding
    - Patients with concurrent illnesses or severe infectious diseases that might preclude study completion
    - Patients with bladder outflow obstruction or unmanageable urinary incontinence
    - Known hypersensitivity to Gallium-68 or to any of the excipients of DOTA-MGS5
    - Any condition that precludes raised arms position for prolonged imaging purposes
    - Prior administration of a radiopharmaceutical within a period corresponding to 8 half-lives of the radionuclide used on such radiopharmaceutical
    - Clinically significant illness or clinically relevant trauma within 3 weeks before the administration of the investigational product
    - Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
    - Persons held in an institution by legal or official or
    E.5 End points
    E.5.1Primary end point(s)
    - Standard safety and tolerability parameters (clinical monitoring, laboratory, ECG)
    - Any serious adverse reactions (SAR) and any suspected unexpected serious adverse reaction (SUSAR) related to the study drug as determined by clinically relevant changes of physiological parameters (blood pressure, heart rate, ECG findings) defined by the CTCAE v5.0
    - Tolerability and safety of the administration of a diagnostic dose of 68Ga-DOTA-MGS5 in patients with advanced MTC and other NET as determined by absence of increased number of SAR and SUSAR compared to other peptide-based radiotracers
    - Generation of time activity curves and calculation of residence times of 68Ga-DOTA-MGS5 in normal organs and tumour lesions
    - Calculation of absorbed tumour-to-organ doses and effective whole-body dose of 68Ga-DOTA-MGS5
    - Quantification of urinary excretion of 68Ga-DOTA-MGS5
    - Calculation of half-life of 68Ga-DOTA-MGS5 in blood
    E.5.1.1Timepoint(s) of evaluation of this end point
    Completion of 12 patients
    E.5.2Secondary end point(s)
    - Description of tumour lesions (number of lesions, uptake per lesion) and comparison with known tumour lesions
    - Preliminary comparison with standard imaging modalities such as 18F-DOPA-PET/CT and 68Ga-SSTRPET/CT (number of lesions, uptake per lesion)
    - Description of the overall, positive and negative agreement on a lesion-by-lesion basis as well as on a patient basis of 68Ga-DOTA-MGS5 PET/CT relative to the standard imaging procedures overall and for each tumour type
    E.5.2.1Timepoint(s) of evaluation of this end point
    Completion of 12 patients
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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 months18
    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: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state12
    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)
    Normal treatment of the underlying condition
    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 Decision2021-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-20
    P. End of Trial
    P.End of Trial StatusCompleted
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