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    Summary
    EudraCT Number:2021-000148-23
    Sponsor's Protocol Code Number:FAPI-PET-Trial
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-03-09
    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 ConcernedGermany - BfArM
    A.2EudraCT number2021-000148-23
    A.3Full title of the trial
    68Ga-FAPI-46 PET for imaging of FAP expressing cancer: A single-center prospective interventional single-arm clinical Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    68Ga-FAPI-46 PET for imaging of FAP expressing cancer: A single-center prospective interventional single-arm clinical Trial
    A.4.1Sponsor's protocol code numberFAPI-PET-Trial
    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 SponsorUniversity Hospital Essen
    B.1.3.4CountryGermany
    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 supportUniversitätsklinikum Essen, Klinik für Nuklearmedizin
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsmedizin Essen - Studienzentrum GmbH
    B.5.2Functional name of contact pointStudy Coordination
    B.5.3 Address:
    B.5.3.1Street AddressHufelandstr. 55
    B.5.3.2Town/ cityEssen
    B.5.3.3Post code45147
    B.5.3.4CountryGermany
    B.5.4Telephone number+4920172377411
    B.5.5Fax number+492017239477411
    B.5.6E-mailume-studienzentrum@uk-essen.de
    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-FAPI-46
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPAuricular use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN68Ga-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 MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number116
    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
    Patients receiving 68Ga-FAPI-46 PET both at initial diagnosis and restaging before treatment decisions
    E.1.1.1Medical condition in easily understood language
    Patients receiving 68Ga-FAPI-46 PET both at initial diagnosis and restaging before treatment decisions
    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
    To assess the positive predictive value, association between 68Ga-FAPI-46 PET uptake intensity and histopathologic FAP expression, detection rate, reproducibility and impact on clinical management of 68Ga-FAPI-46 PET /CT or PET/MRI
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Proven or suspected tumor type:
    • Breast
    • Colorectal
    • Endometrial
    • Esophageal
    • Glioma/GBM
    • Head and neck
    • Hepatocellular carcinoma
    • Lymphoma
    • Melanoma
    • Multiple Myeloma
    • Neuroendocrine
    • NSCLC
    • Ovarian
    • Pancreatic
    • Prostate
    • Renal cell carcinoma
    • Sarcoma
    • SCLC
    • Seminoma
    • Thyroid
    • Unknown primary
    • Other
    2. At initial staging or re-staging of disease
    3. At least one detectable tumor lesion with any diameter >1 cm
    4. Intended or performed surgery or biopsy of tumor within 8 weeks before or after enrollment
    5. Age ≥18 years
    6. Patient Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
    7. Women of child bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, can only be included after a confirmed menstrual period and a negative highly sensitive urine or serum pregnancy test within 24 h before radiopharmaceutical application.
    E.4Principal exclusion criteria
    1. Patient cannot give consent for the study
    2. Patient can not lie flat or tolerate 68Ga-FAPI-46 PET imaging
    3. Prior external beam radiation therapy (EBRT) within 1 month of enrollment to tumor lesions intended for surgery or biopsy
    4. Prior chemotherapy, immunotherapy, biologic or targeted oncologic therapy within 1 month of enrollment
    5. Unwillingness or inability to comply with study and follow-up procedures
    6. History of disease or condition that may critically interfere with participation in this study at the discretion of the investigators
    7. Pregnant, lactating, or breast-feeding women
    8. Women of child bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, are not allowed to participate in this study, unless they are using highly effective methods of contraception during the interventional period. Highly effective contraception methods include:
    • True sexual abstinence: defined as refraining from heterosexual intercourse, when this is in line with the
    preferred and usual lifestyle of the patient. Periodic
    abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods), declaration of abstinence for the duration of exposure to IMP, and withdrawal are not acceptable methods of contraception.
    • Vasectomised partner is a highly effective birth control method if the partner is the sole sexual partner of the study participant and the vasectomised partner has received medical assessment of the surgical success.
    • Bilateral tubal occlusion.
    • Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation:
    - oral
    - intravaginal
    - transdermal
    • Progestogen-only hormonal contraception associated with inhibition of ovulation:
    - oral
    - injectable
    - implantable
    • Placement of an intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
    9. Post-menopausal women are allowed to participate in this study. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms), or six months of spontaneous amenorrhea with serum folliclestimulating hormone (FSH) levels > 40mIU/mL or have had surgical bilateral ophorectomy or bilateral salpingectomy or hysterectomy or tubal ligation at least six weeks prior to screening. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
    10. Sexually active males must use a condom during intercourse during the interventional period. A condom is required to be used also by vasectomized men in order to prevent delivery of the study compound via seminal fluid
    11. QTcF >470 msec for females and QTcF >450 msec for males on screening electrocardiogram (ECG) or history of congenital long QT syndrome
    12. Known or expected hypersensitivity to 68Ga-68-FAPI-46 or any
    of the relevant excipients.
    E.5 End points
    E.5.1Primary end point(s)
    Positive predictive value (PPV) on a per-region- and per-patient-basis (table 3) of 68Ga-FAPI-46 PET for detection of histopathology-FAP-positive tumor lesions, confirmed by histopathology/biopsy (reached for ≥ 75%).
    E.5.1.1Timepoint(s) of evaluation of this end point
    WIthin 8 weeks after Patient enrolment
    E.5.2Secondary end point(s)
    1) Association between 68Ga-FAPI-46 PET uptake intensity and histopathologic FAP expression
    2) Sensitivity and specificity of 68Ga-FAPI-46 PET on a per-patient and per-region-basis for detection of histopathology-FAP-positive tumor lesions confirmed by histopathology/biopsy (separate for regional, extra-regional and distant locations)
    3) Detection rate of 68Ga-FAPI-46 PET versus previous standard imaging on a per-patient and per-region-basis for detection of tumor location, also stratified by tumor maker serum level
    4) Sensitivity and specificity of 68Ga-FAPI-46 PET versus previous standard imaging on a per-patient and per-region-basis for detection of tumor lesions confirmed by combined histopathology/biopsy/follow-up imaging/clinical follow-up reference standard (separate for regional, extra-regional and distant locations)
    5) Impact on management
    6) Inter-reader reproducibility
    7) Safety
    8) Change in staging/prognostic groups.
    E.5.2.1Timepoint(s) of evaluation of this end point
    WIthin 8 weeks after Patient enrolment
    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 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 No
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state155
    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)
    Following completion of this study, all treatments and interventions will be at the investigator’s discretion according to clinical practice and patients’ needs.
    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 Decision2021-06-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-30
    P. End of Trial
    P.End of Trial StatusOngoing
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