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    Summary
    EudraCT Number:2021-006295-17
    Sponsor's Protocol Code Number:MedTrace-002
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-01-27
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2021-006295-17
    A.3Full title of the trial
    A Phase 3, Multicenter, Open Label Study to Confirm the Diagnostic Potential of Intravenously Administered 15O- H2O to Identify Coronary Artery Disease During Pharmacological Stress and Resting Conditions Using PET Imaging
    Et fase 3, multicenter, åbent label forsøg der har til formål at undersøge det diagnostiske potentiale af det radioaktive sporstof 15O-H2O til udredning af kranspulsåresygdom ved brug af PET-skanning udført i hvile og ved induceret farmakologisk stress
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a unblinded Phase 3 multicenter study, investigating the diagnostic properties of 15O-H2O PET MPI in patients with suspected ischemic heart disease .
    Dette er et fase 3, prospektivt, ublindet, multicenterforsøg af 15O-H2O -PET MPI’s diagnostiske egenskaber hos personer med mistænkt iskæmisk hjertesygdom.
    A.3.2Name or abbreviated title of the trial where available
    RAPID-WATER-FLOW
    A.4.1Sponsor's protocol code numberMedTrace-002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05134012
    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 SponsorMedTrace Pharma
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMedTrace Pharma A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedTrace Pharma
    B.5.2Functional name of contact pointSandra Miran
    B.5.3 Address:
    B.5.3.1Street AddressAgern Alle 5 A
    B.5.3.2Town/ cityHørsholm
    B.5.3.3Post code2970
    B.5.3.4CountryDenmark
    B.5.4Telephone number4522167422
    B.5.6E-mailsandra@medtrace.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 nameP3 MT-100, 15O-Water, Sterile Solution for Injection
    D.3.2Product code 7732-18-5
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravascular use (Noncurrent)
    Intravenous bolus use (Noncurrent)
    Injection (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN15O H2O
    D.3.9.1CAS number 7732-18-5
    D.3.9.2Current sponsor code15-O water
    D.3.9.3Other descriptive name(15O) H2O
    D.3.9.4EV Substance CodeSUB12193MIG
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 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 Yes
    D.3.11.13.1Other medicinal product typeAuthorisation for contained use been granted by DKMA (Case no.: 2021062129, Ref: GSTP, Drugid: 27416501820: Title: O-15 vand (MedTrace) "Pet-Centret Aarhus", injektionsvæske 2-130 MBq/ml fra EØS-land
    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
    Coronary Artery Disease
    Kranspulsåre sygdom
    E.1.1.1Medical condition in easily understood language
    Coronary artery stenosis: Narrowing of blood vessels which supplies the heart muscle with blood, leading to ischemia of the heart muscle.
    Kranspulårer forsnævring: Forsnævring af blodårene der forsyner hjertemusklen med blod, der kan medføre iltmangel i hjertemusklen.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10006896
    E.1.2Term CAD
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective:
    Determine the sensitivity and specificity of the 15O-H2O positron emission tomography (PET) myocardial perfusion imaging (MPI) to detect coronary artery disease (CAD) using the truth-standard of invasive coronary angiogram (ICA) with fractional flow reserve (FFR) or instantaneous wave-Free Ration (iFR) coronary computed tomography angiogram (CCTA).
    Primært endepunkt
    Sensitiviteten og specificiteten af 15O-H2O PET til påvisning af koronararterteriesygdom (CAD) og iskæmisk hjertesygdom. Referencestandarden er enten invasiv KAG med FFR, iFR eller HCT.
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    1) Determine the sensitivity and specificity of 15O-H2O PET MPI in subjects of special clinical interest (female, BMI≥30, diabetics, multivessel disease); 2) Evaluation of the safety of 15O-H2O during PET MPI.
    Bestemme følsomheden og specificiteten af 150-H20 PET MPI hos personer af særlige klinisk interesse (kvinder, BMI ≥30, diabetikere, multikar-sygdom); 2)
    Evaluering af sikkerheden ved 150-H20 under PET MPI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female subjects ≥18 years;
    2. Informed consent form (ICF) read, signed, and dated prior to any study procedures being performed;
    3. Subjects who fall into any one of the following categories:
    a) Have been referred for an ICA directly after non-invasive testing (e.g., SPECT or PET MPI, stress echo, CCTA, ETT).
    b) Had an ICA with no intervention. However, if any stenosis >40% but ≤70% was observed, an FFR assessment was performed.
    c) Had a CCTA with normal coronaries or minimal CAD (Less than < 20% stenosis).

    The PET 15O-H2O study and ICA or CCTA testing need to be completed within a 30-day window, with time 0 defined as the date of the first of
    these three tests, or the screening visit for Pathway 1.

    4. Women of Child Bearing Potential (WOCBP) must be non-pregnant, and non-lactating. For women of childbearing potential, the results of a
    urine human chorionic gonadotropin (HCG) pregnancy test (with the result known on the day of drug administration) must be negative;
    these patients must be practicing appropriate birth control from time of the screening until end of the follow up period. For women who are either surgically sterile (have a documented bilateral tubal ligation or oophorectomy and/or hysterectomy) or are post-menopausal (cessation of menses for more
    than 1 year); enrollment in the study without a pregnancy test at screening is allowed.
    5. Male will need to use contraceptive methods until end of the follow-up period.
    6. Patients are able to comply with all study procedures as described in the protocol.
    1. Mandlige og kvindelige forsøgspersoner ≥18 år;
    2. Deltagerinformation og samtykkeerklæringen skal læses, underskrives og dateres, før der udføres forsøgsprocedurer;
    3. Personer, der falder ind under en af følgende kategorier (se ovenfor):
    a) Henvist til invasiv KAG direkte eller efter non-invasiv undersøgelse (ex. SPECT, 82Rb PET, stress ekkokarduiografi, ergometertest)
    b) Har fået foretaget en invasiv KAG uden intervention (PCI). Såfremt stenoser blev vurderet til at være mellem 40 og 70 % skal der foreligge FFR- måling af
    disse.
    c) Har fået foretaget en CT med kontrast med normale forhold eller minimale forandringer (mindre end <20 % stensose).

    PET 15O-H2O-forsøget og KAG eller CT-undersøgelsen skal gennemføres inden for et 30-dages vindue, hvor tidspunkt 0 er defineret som datoen for den første af disse tre tests, eller screening besøg for Pathway 1.

    4. Kvinder i fødedygtig alder må ikke være gravide og må ikke amme. For kvinder i fødedygtig alder skal resultaterne af en graviditetstest med
    humant choriongonadotropin (HCG) i urinen være negativ (med resultatet kendt på dagen for lægemiddeladministrationen); disse patienter
    skal
    praktisere passende prævention fra tidspunktet for screeningsbesøget til afsluttet follow-up.
    For kvinder, der enten er kirurgisk sterile (har en dokumenteret bilateral tuballigation eller ooporektomi og/eller hysterektomi) eller er
    postmenopausale (ophør af menstruation i mere end 1 år), er det tilladt at deltage i forsøget uden graviditetstest ved screening.
    5. Mænd skal bruge prævention indtil afsluttet follow-up.
    6. Patienterne er i stand til at overholde alle forsøgsprocedurer som beskrevet i protokollen.
    E.4Principal exclusion criteria
    1. Subjects are unable to undergo (even partially) any of the imaging procedures;
    2. Subjects with a known history of cardiac disease including:
    a. myocardial infarction, previous coronary revascularization, or chronic ischemic cardiomyopathy
    b. primary myocardial disease such as cardiac amyloidosis or hypertrophic cardiomyopathy
    c. known left ventricular dysfunction
    3. Subjects in whom adenosine stress testing is contraindicated, including but not limited to:
    a. Subjects with severe COPD or chronic asthma.
    b. Subjects with second- or third-degree atrioventricular block without a pacemaker.
    d. moderate or sever aortic or mitral stenosis or regurgitation.
    4. Subjects with claustrophobia to an extent that would limit their ability to undergo PET imaging
    (subjects whose claustrophobia is known to be readily controlled with drugs or psychological
    support may be enrolled).
    5. Subjects who are on sildenafil (Viagra) or oral dipyridamole (Persantine, Aggrenox) therapy and for
    whom its use cannot be terminated or suspended for ≥24 hours prior to treatment of study drug.
    6. Subjects with significant co-morbidities that would prevent appropriate completion of the
    protocol procedures.
    7. Subjects who have participated in another research study using investigational drugs within the 30
    days prior to enrollment (Day 0) or through the duration of the trial (subjects in observational studies with approved agents and
    subjects known to be on placebo may be enrolled).
    8. Subjects who have previously participated in this study.
    9. Subjects with a close affiliation with the investigational site, defined as a close relative to the
    Investigator, or a dependent person such as an employee, student or intern at the investigational
    site.
    10. Subjects scheduled for, or planning to undergo, any interventional cardiac procedures between enrolment and ICA (pathway 1) signing of informed consent (IC) or enrolment and 15O-H2O
    PET MPI (pathway 2 and 3)
    1. Patienterne er ikke i stand til at gennemgå (heller ikke delvist) nogen af
    2. Patienter med en kendt hjertesygdom, herunder:
    a) myokardieinfarkt, tidligere koronar revaskularisering eller kronisk iskæmisk kardiomyopati
    b) primær myokardiesygdom som f.eks. kardiel amyloidose eller hypertrofisk kardiomyopati
    c) kendt venstre ventrikulær dysfunktion
    3. Patienter, hos hvilke adenosin-stresstest er kontraindiceret, herunder, men ikke begrænset til, følgende:
    a) Patienter med svær kronisk obstruktiv lungesygdom (KOL) eller kronisk astma.
    b) Patienter med atrioventrikulær blok af anden- eller tredje grad uden pacemaker.
    d. moderate eller svær aorta- eller mitralstenose eller regurgitation.

    4. Patienter med klaustrofobi i et omfang, der begrænser deres evne til at gennemgå PET-skanning (patienter, hvis klaustrofobi vides at være let at
    kontrollere med medicin eller psykologisk støtte, kan deltage).
    5. Patienter, der er i behandling med sildenafil (Viagra) eller oral dipyridamol (Persantine, Aggrenox), og for hvem brugen heraf ikke kan afsluttes eller
    suspenderes i ≥24 timer før behandling med forsøgspræparatet.
    6. Patienter med betydelige co-morbiditeter, der kan forhindre en hensigtsmæssig gennemførelse af protokollens procedurer.
    7. Patienter, der har deltaget i et andet forskningsstudie med forsøgslægemidler inden for de sidste 30 dage før inklusionen (dag 0), eller under forsøgets
    varighed (patienter i observationsstudier med godkendte midler og patienter, der vides at være på placebo, kan inkluderes).
    8. Patienter, der tidligere har deltaget i dette forsøg.
    9. Patienter med en tæt tilknytning til forsøgsstedet, defineret som en nær slægtning til personen som gennemfører forsøget eller en afhængig
    person som f.eks. en ansat, studerende eller praktikant på forsøgsstedet.
    10. Personer som har planlagt eller planlægger at gennemgå en hvilke som helt inventionel hjerteprodurer mellem inklusion og ICA (Pathway 1) underskrift af deltagerinformationen/informed consent eller inklusion
    og 15O-H2O PET MPI (Pathway 2 og 3)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoints of the study are the sensitivity and specificity of 15O-H2O Injection PET MPI in the detection of significant CAD. The truth standard used in this study is the presence of clinically significant CAD as assessed by either ICA with FFR or CCTA.
    De primær effektmål i undersøgelsen er 15O-H2O-injektion PET MPI's sensitivitet og specificitet ved påvisning af signifikant CAD. Den sandhedsstandard, der anvendes i denne undersøgelse, er tilstedeværelse af klinisk signifikant CAD, som vurderet ved enten ICA med FFR eller CCTA.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Upon completion of either PET and ICA studies or PET and CCTA
    Efter afslutning af enten PET samt ICA eller PET samt CCTA
    E.5.2Secondary end point(s)
    None
    Ingen
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    NA
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA3
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    Denmark
    Netherlands
    Sweden
    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
    SBSS
    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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 85
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 215
    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)
    Treatment or care after the subject has ended the participation in the trial is not different from the expected normal treatment of that condition
    Behandling efter forsøgspersonen har afsluttet deltagelsen i dette forsøg, er ikke anderledes fra den forventede normale behandling af denne sygdom.
    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 Decision2022-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-08
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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