Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43870   clinical trials with a EudraCT protocol, of which   7289   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2022-001867-29
    Sponsor's Protocol Code Number:1081HV
    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:2022-11-02
    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 number2022-001867-29
    A.3Full title of the trial
    [68Ga]Ga-FAPI-46 positron emission tomography in pancreaticobiliary cancers: a pharmacokinetics, repeatability and diagnostic accuracy study.
    [68Ga]Ga-FAPI-46 positron emissie tomografie in pancreaticobiliaire tumoren: een farmacokinetiek, herhaalbaarheid en diagnostiek studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    [68Ga]Ga-FAPI-46 positron emission tomography (PET) scan to improve the imaging of pancreatic and bile duct cancer.
    [68Ga]Ga-FAPI-46 positron emissie tomografie (PET) scan voor het beter zichtbaar maken van alvleesklier- en galwegkanker.
    A.3.2Name or abbreviated title of the trial where available
    PANSCAN-1
    PANSCAN-1
    A.4.1Sponsor's protocol code number1081HV
    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 supportKWF kankerbestrijding, young investigators grant (No. 11289)
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportCCA grant (No. CCA-2-29)
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportCholangiocarcinoma Foundation Research Fellowship
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmsterdam UMC, location VUmc
    B.5.2Functional name of contact pointR.B. Henrar
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310204444444
    B.5.6E-mailr.b.henrar@amsterdamumc.nl
    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]Ga-FAPI-46
    D.3.2Product code V09IX
    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 INN[68Ga]Ga-FAPI-46
    D.3.9.3Other descriptive name(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-cyano-4,4-difluoropyrrolidin-1-yl)-2-oxoethylcarbamoyl)-quinolin-6-yl)(methyl)amino)-propyl)piperazin-1-yl)-2-oxoethyl)-68Ga-[1,4,7,10]-tetraazacyclododecane-1,4,7-triyl)triacetate
    D.3.9.4EV Substance CodeSUB221944
    D.3.10 Strength
    D.3.10.1Concentration unit Bq/ml becquerel(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 100
    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
    Pancreatic carcinoma and cholangiocarcinoma
    Pancreascarcinoom en cholangiocarcinoom
    E.1.1.1Medical condition in easily understood language
    Cancer of the pancreas and cancer of the bile duct
    Alvleesklierkanker en galwegkanker
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A: To perform a full pharmacokinetic analysis of [68Ga]Ga-FAPI-46. Based on the pharmacokinetic analysis (reference method), simplified methods for quantification of [68Ga]Ga-FAPI-46 uptake will be identified and validated.
    Part B: To determine the repeatability of the most suitable simplified quantitative measurements (as derived from Part A) for quantification of [68Ga]Ga-FAPI-46 uptake.
    Part C:
    1. To determine the diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT to detect primary PDAC and (lymph node) metastases.
    2. To determine the diagnostic accuracy of response monitoring using [68Ga]Ga-FAPI-46 PET/CT.
    Deel A: Om een volledig farmacokinetische analyse van [68Ga]Ga-FAPI-46 te verrichten. Op basis van de farmacokinetische analyse (referentie methode), zal een gesimplificeerde methode voor kwantificatie [68Ga]Ga-FAPI-46 opname worden geïdentificeerd en gevalideerd.
    Deel B: Om de herhaalbaarheid van de gesimplificeerde kwantificatie methode (vastgesteld in deel A) voor kwantificatie van [68Ga]Ga-FAPI-46 opname.
    Deel C:
    1. Om de diagnostieke accuraatheid van [68Ga]Ga-FAPI-46 PET/CT voor primaire PDAC en (lymfeklier) metastasen vast te stellen.
    2. Om de diagnostieke accuraatheid van chemotherapie response door middel van [68Ga]Ga-FAPI-46 PET/CT vast te stellen.
    E.2.2Secondary objectives of the trial
    N/A
    n.v.t.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients aged 18 years or older.
    - Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
    - Additional Part A: patients with pancreaticobiliary cancer (pancreatic, intra- or extrahepatic cholangiocarcinoma) and a minimum tumor size of 20mm on CT.
    - Additional Part B: patients with primary pancreatic (or pancreaticobiliary) cancer (depending on the results of part A) with a minimum tumor size of 20mm on CT. No treatment may be given in between the two scans.
    - Additional Part C: patients with pathologically proven pancreatic ductal adenocarcinoma, eligible for neoadjuvant therapy before surgical resection.
    - Patienten van 18 jaar of ouder
    - Voor patiënt registratie moet schriftelijk informed consent gegeven worden, in overeenstemming met ICH/GCP en de nationale/lokale voorschriften.
    - Aanvullend Deel A: Patiënten met pancreaticobiliaire carcinoom (pancreas, intra- of extrahepatisch cholangiocarcinoom) en tumor grootte van minimaal 20mm op CT.
    - Aanvullend Deel B: Patiënten met pancreas (of pancreaticobiliaire) carcinoom (afhankelijk van resultaten in deel A) en een tumor grootte van minimaal 20mm op CT, zonder behandeling tussen de 2 scans.
    - Aanvullend Deel C: Patiënten met pathologisch bewezen ductaal adenocarcinoom van het pancreas, die in aanmerking komen voor neoadjuvante therapie voor chirurgische resectie.
    E.4Principal exclusion criteria
    - Women who are pregnant and/or lactating.
    - Medical or psychiatric conditions that compromise the patient’s ability to give informed consent. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
    - Impaired renal function (creatinine clearance ≤60 mL/min according to the Cockcroft-Gault equation
    - Leucocytes (WBC) ≤3.0 x 109/l
    - Platelets ≤ 100 x 109 /l
    - Hemoglobin ≤ 6 mmol/l
    - Known hypersensitivity to drugs comparative to [68Ga]Ga-FAPI-46, or any of the excipients of [68Ga]Ga-FAPI-46.
    - Inability to undergo PET/CT scanning (e.g. claustrophobia, weight limits or inability to tolerate lying for the duration of a PET/CT scan (~90 min).

    Additional Part A:
    - Contra-indication for arterial cannulation (e.g. inadequate circulation of extremity, positive Allen test, severe atherosclerosis, coagulant disorder (INR >1.4 or APTT >50)).

    Additional Part C:
    - Not eligible for surgery after neoadjuvant chemotherapy.
    - If based on the first FAPI-46 PET/CT, there is a suspicion of metastatic disease the images will be discussed in the multidisciplinary meeting and one additional imaging modality (and a biopsy, if this would lead to a change of treatment strategy) can be used to confirm the suspicion. If metastatic disease is confirmed the patient will be excluded.
    - Zwangere vrouwen of vrouwen die borstvoeding geven
    - Medische of psychiatrische aandoeningen die (mogelijk) voorkomen dat patiënt informed consent kan geven. Aanwezigheid van enige psychologisch, familiaire, sociologische of geografische aandoening of positie die potentieel in de weg staat met het volgen van het studie protocol of follow-up schema.
    - Verminderde nierfunctie (kreatinine klaring ≤60 mL/min volgens de Cockcroft-Gault formule)
    - Leucocyten getal ≤3.0 x109 /l
    - Trombocyten getal ≤100 x 109 /l
    - Hemoglobine waarde ≤6 mmol/l
    - Bekende overgevoeligheid voor medicatie vergelijkbaar met [68Ga]Ga-FAPI-46, of een van de gebruikte hulpstoffen van [68Ga]Ga-FAPI-46
    - Omstandigheden of eigenschappen welke voorkomen dat patient een PET/CT scan kan ondergaan (e.g. claustrofobie, gewicht limitaties or niet kunnen platliggen gedurende de PET/CT scan (~90 min).

    Aanvullend Deel A:
    - Contra-indication voor het plaatsen van een arteriele lijn (bijv. inadequate circulatie van een ledemaat, positieve test van Allen, ernstige arteriosclerose, stollingsstoornis (INR >1.4 of APTT >50)).

    Aanvullend Deel C:
    - Niet meer in aanmerking komen voor resectie na neoadjuvante chemotherapie.
    - Indien op basis van de eerste FAPI-46 PET/CT, er een verdenking van metastatische ziekte is, zullen de beelden besproken worden in het multidisciplinaire overleg en kan een aanvullende beeldvormend onderzoek verricht worden (en een biopsie indien dit zou lijden tot een beleids verandering) om de verdenking te bevestigen. Indien de metastase bevestigd is, zal de patient geëxcludeerd worden.
    E.5 End points
    E.5.1Primary end point(s)
    Part A: Pharmacokinetic analysis
    1. The optimal kinetic model to quantify [68Ga]Ga-FAPI-46 pharmacokinetics and tracer uptake.
    2. The most suitable simplified quantitative measurement, as a surrogate for the full kinetic model.

    Part B: Test-retest variation study
    1. The daily variability (average percentage of difference) of the preferred simplified method for quantification of [68Ga]Ga-FAPI-46.

    Part C: Diagnostic accuracy
    1. Per lesion analysis of diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT .
    2. Diagnostic accuracy of response monitoring using [68Ga]Ga-FAPI-46 PET/CT.
    Deel A: Farmacokinetische analyse
    1. Het optimale kinetische model te identificeren van [68Ga]Ga-FAPI-46 om de farmacokinetiek en binding van de tracer te kwantificeren.
    2. Het meeste passende gesimplificeerde kwantitatieve methode te vinden als surrogaat voor de volledige kinetische methode.

    Deel B: Test-retest variatie studie
    1. De dagelijkse variabiliteit (gemiddelde percentage verschil) in de geprefereerde gesimplificeerde methode (uit deel A) voor de kwantificatie van [68Ga]Ga-FAPI-46.

    Deel C: Diagnostische accuraatheid
    1. Per laesie analyse voor de diagnostische accuraatheid voor [68Ga]Ga-FAPI-46 PET/CT voor pancreas carcinoom
    2. Diagnostische accuraatheid voor respons monitoring na chemotherapie door middel van [68Ga]Ga-FAPI-46 PET/CT .
    E.5.1.1Timepoint(s) of evaluation of this end point
    The estimate is that part A will take approximately 6 months to finish inclusion.
    For part B the estimate is 12 months and part C is estimated at 24 months.
    De schatting is dat deel A ongeveer 6 maanden zal duren tot alle patienten zijn geincludeerd.
    Deel B wordt geschat op ongeveer 12 maanden en deel C op ongeveer 24 maanden.
    E.5.2Secondary end point(s)
    Part C:
    1. Percentage of agreement between tumor uptake on the [68Ga]Ga-FAPI-46 PET/CT scan, histopathologic evidence of tumor, and the expression of FAP (IHC).
    2. Percentage of potential change of therapy management enabled by [68Ga]Ga-FAPI-46 PET/CT.
    3. Percentage of agreement between different imaging modalities ([68Ga]Ga-FAPI-46 PET/CT and CT, MRI or FDG PET/CT).
    4. Sensitivity of response prediction based on the first [68Ga]Ga-FAPI-46 PET/CT.
    5. Accuracy of determining surgical resectability using [68Ga]Ga-FAPI-46 PET/CT.
    6. Correlation between [68Ga]Ga-FAPI-46 PET/CT signal to tumor regression (MDACC method).
    7. Diagnostic accuracy of incidental findings on [68Ga]Ga-FAPI-46 PET/CT.
    Deel C:
    1. Percentage overeenkomst tussen tumor opname op de [68Ga]Ga-FAPI-46 PET/CT scan, histopathologische aanwezigheid van tumor, en expressie van FAP (IHC).
    2. Percentage van potentiele beleidsverandering op basis van [68Ga]Ga-FAPI-46 PET/CT.
    3. Percentage overeenkomst tussen de verschillende beeldvormende onderzoeken ([68Ga]Ga-FAPI-46 PET/CT en CT, MRI of FDG PET/CT)
    4. Sensitiviteit van response predictie op basis van de eerste [68Ga]Ga-FAPI-46 PET/CT.
    5. Accuraatheid van [68Ga]Ga-FAPI-46 PET/CT voor het bepalen van de mogelijkheid tot chirurgisch resectie.
    6. Correlatie tussen [68Ga]Ga-FAPI-46 PET/CT signaal en tumor regressie (MDACC methode).
    7. Diagnostische accuraatheid van toevalsbevindingen op [68Ga]Ga-FAPI-46 PET/CT.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of inclusion of part C (estimated at 24 months after start of inclusion).
    Aan het einde van inclusie van deel C (geschat op 24 maanden na start van inclusie).
    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 No
    E.6.6Pharmacokinetic Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Development of pharmacokinetic model for Ga68-FAPI-46 uptake
    Ontwikkelen van farmacokinetisch model voor Ga68-FAPI-46 uptake
    E.7.2Therapeutic exploratory (Phase II) Yes
    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.8.3 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
    The study will be stopped in all study Parts in the setting of unacceptable AEs (adverse events) related to the PET-scans (grade III or higher).
    In part C there is a feasibility stopping rule if at the interim analysis after 15 patients the sensitivity for detection of pancreatic cancer is <60%.
    Otherwise the end of the trial will be last visit of the last subject.
    De studie zal gestopt worden in alle onderdelen van de studie indien er onacceptabele AE's gerelateerd aan de PET-scans optreden (graad III of hoger).
    In deel C is er een haalbaarheids toets bij de interim analyse als na 15 patienten de sensitiviteit voor detectie van pancreas carcinoom <60% is.
    Anders zal het einde van de studie laatste afspraak van laatste patient zijn
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 state63
    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)
    No extra follow-up appointments will be made outside of standard follow-up.
    Er zullen geen extra controle afspraken buiten standaard controle afspraken worden gemaakt.
    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 Decision2022-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-31
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Wed May 01 03:36:41 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA