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    Summary
    EudraCT Number:2020-002205-26
    Sponsor's Protocol Code Number:FNUSA-2020-01
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-05-18
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2020-002205-26
    A.3Full title of the trial
    [68Ga] -SomaKIT-TOC PET / CT in postoperative evaluation of meningioma residues in the cranial base area
    [68Ga]-SomaKIT-TOC PET/CT v pooperačním hodnocení rezidua meningeomů v oblasti baze lební
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    [68Ga] -SomaKIT-TOC PET / CT in postoperative evaluation of meningioma residues in the cranial base area
    [68Ga]-SomaKIT-TOC PET/CT v pooperačním hodnocení rezidua meningeomů v oblasti baze lební
    A.3.2Name or abbreviated title of the trial where available
    [68Ga]-SomaKIT-TOC] PET/CT
    [68Ga]-SomaKIT-TOC] PET/CT
    A.4.1Sponsor's protocol code numberFNUSA-2020-01
    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 SponsorFakultní nemocnice u sv. Anny v Brně
    B.1.3.4CountryCzech Republic
    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 supportFakultní nemocnice u sv. Anny v Brně
    B.4.2CountryCzech Republic
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFakultní nemocnice u sv. Anny v Brně
    B.5.2Functional name of contact pointOddělení klinických studií
    B.5.3 Address:
    B.5.3.1Street AddressPekařská 664/53
    B.5.3.2Town/ cityBrno
    B.5.3.3Post code65691
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number+420543185443
    B.5.6E-mailtrials.icrc@fnusa.cz
    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 Galliapharm
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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.3.4Pharmaceutical form Radionuclide generator
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPExtracorporeal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGALLII (68GA) CHLORIDUM
    D.3.9.3Other descriptive nameGALLIUM (68GA)
    D.3.9.4EV Substance CodeSUB194211
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,74-1,85
    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.IMP: 2
    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 Somakit TOC
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Kit for radiopharmaceutical preparation
    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 INNEDOTREOTIDE
    D.3.9.3Other descriptive nameedotreotidum
    D.3.9.4EV Substance CodeSUB179386
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    evaluation of meningioma residues in the cranial base area
    hodnocení rezidua meningeomů v oblasti baze lební
    E.1.1.1Medical condition in easily understood language
    evaluation of meningioma residues in the cranial base area
    hodnocení rezidua meningeomů v oblasti baze lební
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10027191
    E.1.2Term Meningioma
    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 SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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
    Evidence and evaluation of radiopharmaceutical accumulation [68Ga] -SomaKIT-TOC in patients after extinction of meningioma in the cranial base area
    Průkaz a zhodnocení akumulace radiofarmaka [68Ga]-SomaKIT-TOC u pacientů po exstirpaci meningeomu v oblasti baze lební.
    E.2.2Secondary objectives of the trial
    Volumetric comparison of [68Ga] -SomaKIT-TOC PET / CT positivity and saturation after administration of a contrast agent to MR in the area of the original tumor. We verify the assumption that [68Ga] -SomaKIT-TOC can be used to refine the extent of meningioma residue for possible postoperative radiotherapy or prospective monitoring of its extent.
    Comparison of the sensitivity of [68Ga] -SomaKIT-TOC PET / CT and MR with a contrast agent in distinguishing residual meningioma tumor tissue from postoperative changes in the cranial base.
    Safety assessment of the applied product [68Ga] -SomaKIT-TOC.
    Volumetrické srovnání pozitivity [68Ga]-SomaKIT-TOC PET/CT a sycení po podání kontrastní látky na MR v oblasti původního nádoru. Ověříme předpoklad, že [68Ga]-SomaKIT-TOC lze využít ke zpřesnění rozsahu rezidua meningeomu pro případnou pooperační radioterapii nebo prospektivní sledování jeho rozsahu.
    Porovnání senzitivity [68Ga]-SomaKIT-TOC PET/CT a MR s kontrastní látkou při odlišení reziduální nádorové tkáně meningeomu od pooperačních změn v oblasti baze lební.
    Hodnocení bezpečnosti aplikovaného přípravku [68Ga]-SomaKIT-TOC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. age ≥18 years
    2. histologically proven diagnosis of WHO grade I-III meningioma in the area of ​​the base of the skull
    3. condition after cranial meningioma surgery in the previous 20 years
    4. stage of Simpson II - V resection (ie patients with Simpson I resection will not be included, in whom the complete tumor has been clearly removed, including the surrounding dura mater and bone to a sufficient extent)
    5. signed informed consent
    6. ECOG PS 0-2
    7. laboratory values:
    7.1. bilirubin <1.5x upper limit of normal
    7.2. creatinine <1.5x upper limit of normal
    7.3. urea <1.5x upper limit of normal
    7.4. platelets> 50x 10 to 9 / l
    8. ability to undergo MR and PET / CT examinations
    9. the ability of the assessment body to cooperate as required by the Protocol
    10. participants in a clinical trial of childbearing potential must agree to the use of prescribed methods of contraception for at least one month following a single dose of study medication

    women - observance of sexual abstinence or use of an adequate contraceptive method (ie condom) in the case of sexual intercourse, ev. the presence of bilateral tubal occlusion or vasectomy in the partner
    men - observance of sexual abstinence or use of an adequate contraceptive method (ie condom) in case of sexual intercourse
    1. věk ≥18 let
    2. histologicky prokázaná diagnóza meningeomu WHO grade I-III v oblasti baze lební
    3. stav po operaci meningeomu baze lební v předchozích 20 letech
    4. stupeň resekce Simpson II – V (tj. nebudou zahrnuti pacienti s resekcí Simpson I, u nichž byl jednoznačně odstraněn kompletní nádor i s okolní tvrdou plenou a kostí v dostatečném rozsahu)
    5. podepsaný informovaný souhlas
    6. ECOG PS 0-2
    7. laboratorní hodnoty:
    7.1. bilirubin < 1,5x horní hranice normálu
    7.2. kreatinin < 1,5x horní hranice normálu
    7.3. urea < 1,5x horní hranice normálu
    7.4. trombocyty > 50x 10 na 9 / l
    8. schopnost podstoupit vyšetření MR a PET/CT
    9. schopnost subjektu hodnocení spolupracovat dle požadavků protokolu
    10. účastníci klinického hodnocení v plodném věku musí souhlasit s používáním předepsaných metod antikoncepce minimálně jeden měsíc následující po jednorázovém podání studijní medikace

    ženy – dodržování sexuální abstinence nebo použití adekvátní antikoncepční metody (tj. kondomu) v případě pohlavního styku, ev. přítomnost oboustranné tubární okluze nebo vazektomie u partnera
    muži – dodržování sexuální abstinence nebo použití adekvátní antikoncepční metody (tj. kondomu) v případě pohlavního styku
    E.4Principal exclusion criteria
    1. known hypersensitivity to any component of the investigational product according to SPC
    2. history of severe forms of polyvalent allergy
    3. inability to undergo MR examination (neurostimulator, pacemaker, cochlear implant, metal implant of unclear anamnesis, metal chips in the eye)
    4. morbid obesity or deformity of the torso preventing passage through the opening of the CT or MR device
    5. claustrophobia or inability to lie down for 20 minutes without moving
    6. the presence of any mental, family, social or geographical facts that could impede the procedure in accordance with the protocol - these facts must be discussed with the subject before inclusion in the clinical trial
    1. známá hypersenzitivita na jakoukoliv součást hodnoceného přípravku dle SPC
    2. závažné formy polyvalentní alergie v anamnéze
    3. neschopnost absolvovat MR vyšetření (neurostimulátor, kardiostimulátor, kochleární implantát, kovový implantát nejasné anamnézy, kovové špony v oku)
    4. morbidní obezita nebo deformita trupu bránící prostupu přes otvor CT či MR přístroje
    5. klaustrofobie nebo neschopnost ležet 20 min bez pohnutí
    6. přítomnost jakýchkoli duševních, rodinných, sociálních či geografických skutečností, které by mohly být překážkou postupu v souladu s protokolem - tyto skutečnosti musí být se subjektem hodnocení před jeho zařazením do klinického hodnocení prodiskutovány
    E.5 End points
    E.5.1Primary end point(s)
    Visual identification of pathological (tumor) tissue using semi-quantitative evaluation of the ratio (T / B) of radiopharmaceutical accumulation in the lesion (SUVmaxTumor) to background (SUVmaxBackground)> 1.3; RT / B = SUVmaxT / SUVmaxB.
    Vizuální identifikace patologické (nádorové) tkáně za využití semikvantitativního hodnocení poměru (ratio T/B) akumulace radiofarmaka v ložisku (SUVmaxTumor) vzhledem k pozadí (SUVmaxBackground) > 1,3; RT/B = SUVmaxT/SUVmaxB.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 0 (day of examination)
    Den 0 (den aplikace hodnoceného léčivého přípravku)
    E.5.2Secondary end point(s)
    Volumetric comparison of positive areas according to [68Ga] -SomaKIT-TOC PET / CT (area with radiopharmaceutical accumulation T / B higher than 1.3 and MR (saturation area after contrast administration).
    We compare the correlation between tumor-positive regions according to [68Ga] -SomaKIT-TOC PET / CT T / B above 1.3 using the cranial base segmentation method and tumor-positive regions according to MR with a contrast agent based on the evaluation of an independent radiologist.
    Volumetrické porovnání pozitivních oblastí dle [68Ga]-SomaKIT-TOC PET/CT (oblast s akumulací radiofarmaka T/B vyšší než 1,3 a MR (oblast sycení po podání kontrastní látky).
    S využitím metody segmentace baze lební semi-kvantitativně porovnáme korelaci mezi tumor pozitivními oblastmi dle [68Ga]-SomaKIT-TOC PET/CT T/B nad 1,3 a tumor pozitivními oblastmi dle MR s kontrastní látkou za základě hodnocení nezávislého radiologa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 0 (day of examination)
    Den 0 (den aplikace hodnoceného léčivého přípravku)
    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 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 December 2023
    poslední návštěva posledního pacienta prosinec 2023
    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: 20
    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 No
    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 state30
    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 Decision2020-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-10
    P. End of Trial
    P.End of Trial StatusOngoing
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