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    Summary
    EudraCT Number:2022-002751-19
    Sponsor's Protocol Code Number:82160
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-03-26
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2022-002751-19
    A.3Full title of the trial
    FAPi-PET imaging of in vivo fibrosis in inflammatory bowel disease patients
    FAPi-PET beeldvorming van in vivo fibrose in patiënten met inflammatoire darmziekten
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    FAPi-PET imaging of in vivo fibrosis in inflammatory bowel disease patients
    FAPi-PET beeldvorming van darmverlittekening in inflammatoire darmziekten
    A.3.2Name or abbreviated title of the trial where available
    PIMAFI
    PIMAFI
    A.4.1Sponsor's protocol code number82160
    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 SponsorAmsterdam UMC
    B.1.3.4CountryNetherlands
    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 supportAmsterdam UMC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmsterdam UMC
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+310205669111
    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 name[68Ga]FAPI-46
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Inflammatory Bowel Diseases
    Inflammatoire darmziekten
    E.1.1.1Medical condition in easily understood language
    Inflammatory Bowel Diseases
    Inflammatoire darmziekten
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Our main objectives are:
    1. To evaluate the feasibility of 68Ga-FAPi PET/CT in detecting intestinal fibrosis in patients with IBD
    2.To optimize the acquisition and reconstruction methodology and identifying simplistic uptake measurements for FAPi PET/CT for detecting and measuring intestinal fibrosis.
    Onze hoofddoelen zijn:
    1. Het beoordelen van de visibility (zichtbaarheid) van 68Ga-FAPi PET/CT voor het opsporen van darmfibrose bij patiënten met IBD
    2. De acquisitie- en reconstructiemethodologie optimaliseren en simplistische opnamemetingen voor FAPi PET/CT identificeren voor het detecteren en meten van darmfibrose.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    1. Visual and semi-quantitative evaluation of the pharmacokinetics (PK) of 68Ga-FAPi in patients with a) Crohn’s disease and b) ulcerative colitis compared to bowel uptake reference values as derived in other Amsterdam UMC 68Ga-FAPi imaging studies in patients not suffering from IBD (when signed informed consent is available).
    2. To define optimal (single and/or dual) time point(s) post injection for imaging FAP activity in Crohn’s disease and ulcerative colitis.
    3. Determine the minimal tracer injection dose required to have comparable disease detection performance on PET as to the full tracer injection dose PET.

    Exploratory endpoint:
    To determine to what extent 68Ga-FAPi bowel uptake in IBD patients corresponds to conventional imaging modalities and FAP protein and transcriptome expression levels.
    De secundaire doelen zijn:
    1. Visuele en semi-kwantitatieve evaluatie van de farmacokinetiek (PK) van 68Ga-FAPi bij patiënten met a) de ziekte van Crohn en b) colitis ulcerosa vergeleken met darmreferentiewaarden zoals afgeleid in andere Amsterdam UMC 68Ga-FAPi-beeldvormende onderzoeken bij patiënten die niet lijden van IBD (indien ondertekend geïnformeerde toestemming beschikbaar).
    2. Optimale (enkele en/of dubbele) tijdstippen na injectie definiëren voor het in beeld brengen van FAP-activiteit bij de ziekte van Crohn en colitis ulcerosa.
    3. Bepalen van de minimale tracer-injectedosis die nodig is om vergelijkbare ziektedetectie prestaties op PET te hebben

    Exploratief eindpunt:
    In vivo fibrose beoordelen met behulp van 68Ga-FAPi PET/CT-scanning en bepalen in welke mate dit overeenkomt met conventionele beeldvormingsmodaliteiten en FAP-eiwit- en transcriptoom expressieniveaus als verkennend onderzoek.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Group 1
    - Adults ≥18 years with confirmed diagnosis of Crohn’s disease
    AND one of the following:
    - Gastrointestinal complaints such as diarrhea, bloody and/ or lose stools and abdominal pain, or obstructive symptoms.
    - Increased CRP (>5 mg/L) and/or fecal calprotectin levels (>250 mg/kg)
    - Active disease confiremed by endoscopy ( endoscopic SES-CD score >3)
    - Active disease confirmed by IUS or MRI (bowel wall thickening, signs of active disease)

    Group 2
    - Adults ≥18 years with confirmed diagnosis of ulcerative colitis
    AND one of the following:
    - Active disease confirmed by endoscopy (endoscopic Mayo score ≥ 2) or
    - Active disease confirmed by intestinal ultrasound (BWT > 3 mm in atleast one bowel segment and atleast one other pathological IUS parameter)
    - Increased CRP (>5 mg/L) and/or fecal calprotectin levels (>250 mg/kg)
    Groep 1
    - Volwassenen ≥18 jaar met bevestigde diagnose van de ziekte van Crohn
    EN een van de volgende:
    - Maagdarmklachten zoals diarree, bloederige en/of dunne ontlasting en buikpijn, of obstructieve symptomen.
    - Verhoogde CRP (>5 mg/L) en/of fecale calprotectinespiegels (>250 mg/kg)
    - Actieve ziekte bevestigd door endoscopie (endoscopische SES-CD score >3)
    - Actieve ziekte bevestigd door IUS of MRI (darmwandverdikking, tekenen van actieve ziekte)

    Groep 2
    - Volwassenen ≥18 jaar met bevestigde diagnose van colitis ulcerosa
    EN een van de volgende:
    - Actieve ziekte bevestigd door endoscopie (endoscopische Mayo-score ≥ 2) of
    - Actieve ziekte bevestigd door intestinale echografie (BWT > 3 mm in ten minste één darmsegment en ten minste één andere pathologische IUS-parameter)
    - Verhoogde CRP (>5 mg/L) en/of fecale calprotectinespiegels (>250 mg/kg)
    E.4Principal exclusion criteria
    - Pregnancy
    - Unable to provide informed consent
    - IBD-related surgeries in medical history
    - Colorectal carcinoma
    - Zwangerschap
    - Niet in staat om geïnformeerde toestemming geven
    - IBD-gerelateerde operaties in de medische geschiedenis
    - Colorectaal carinoom
    E.5 End points
    E.5.1Primary end point(s)
    1. Detection of areas with increased 68Ga-FAPi uptake (both visually as semi-quantitatively) in the terminal ileum and colon on baseline PET/CT of active Crohn’s disease patients compared to bowel uptake reference values as derived in other Amsterdam UMC 68Ga-FAPi PET imaging studies in patients not suffering from IBD (when signed informed consent is available).
    2. Detection of areas with increased 68Ga-FAPi uptake (both visually as semi-quantitatively) in the terminal ileum and colon on baseline PET/CT of ulcerative colitis patients compared to bowel uptake reference values as derived in other Amsterdam UMC 68Ga-FAPi PET imaging studies in patients not suffering from IBD (when signed informed consent is available).
    1. Detectie van gebieden met verhoogde 68Ga-FAPi-opname (zowel visueel als semi-kwantitatief) in het terminale ileum en colon op baseline PET/CT van patiënten met actieve ziekte bij de ziekte van Crohn in vergelijking met referentiewaarden voor opname in de darm zoals afgeleid in andere Amsterdam UMC 68Ga-FAPi PET-beeldvormingsonderzoeken bij patiënten die niet aan IBD lijden (indien ondertekende geïnformeerde toestemming beschikbaar is).
    2. Detectie van gebieden met verhoogde 68Ga-FAPi-opname (zowel visueel als semi-kwantitatief) in het terminale ileum en colon op baseline PET/CT van patiënten met actieve colitis ulcerosa in vergelijking met referentiewaarden voor darmopname zoals afgeleid in andere Amsterdam UMC 68Ga-FAPi PET beeldvormingsonderzoeken bij patiënten die niet aan IBD lijden (indien ondertekende geïnformeerde toestemming beschikbaar is).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Two years
    Twee jaar
    E.5.2Secondary end point(s)
    1. Visual and semi-quantitative evaluation of the pharmacokinetics (PK) of 68Ga-FAPi in patients with a) Crohn’s disease and b) ulcerative colitis compared to bowel uptake reference values as derived in other Amsterdam UMC 68Ga-FAPi imaging studies in patients not suffering from IBD (when signed informed consent is available).
    2. To define optimal (single and/or dual) time point(s) post injection for imaging FAP activity in Crohn’s disease and ulcerative colitis.
    3. Determine the minimal tracer injection dose required to have comparable disease detection performance on PET as to the full tracer injection dose PET.
    1. Visuele en semi-kwantitatieve evaluatie van de farmacokinetiek (PK) van 68Ga-FAPi bij patiënten met a) de ziekte van Crohn en b) colitis ulcerosa vergeleken met referentiewaarden voor opname in de darm zoals afgeleid in andere beeldvormingsonderzoeken van Amsterdam UMC 68Ga-FAPi bij patiënten niet lijdend aan IBD (wanneer ondertekende geïnformeerde toestemming beschikbaar is).
    2. Optimale (enkele en/of dubbele) tijdstippen na injectie definiëren voor het in beeld brengen van FAP-activiteit bij de ziekte van Crohn en colitis ulcerosa.
    3. Bepaal de minimale tracer-injectedosis die nodig is om vergelijkbare ziektedetectieprestaties op PET te hebben als bij de volledige tracer-injectiedosis PET.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Two years
    Twee jaar
    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 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) 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    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 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: 15
    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 state15
    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)
    None
    Geen
    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 Decision2023-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-21
    P. End of Trial
    P.End of Trial StatusOngoing
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