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    Summary
    EudraCT Number:2019-002462-12
    Sponsor's Protocol Code Number:NL70085.058.19
    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:2019-08-08
    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 number2019-002462-12
    A.3Full title of the trial
    Imaging tumor angiogenesis using [18F]-PSMA-1007 PET/CT in patients with colon and gastric cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Specific PET scan for patients with bowel or gastric cancer.
    A.4.1Sponsor's protocol code numberNL70085.058.19
    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 SponsorLeiden Universitair Medisch Centrum
    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 supportEuropean Research Council
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden Universitair Medisch Centrum
    B.5.2Functional name of contact pointPhD student
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 3
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333RC
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031639885046
    B.5.6E-mailf.a.vuijk@lumc.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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[18F]PSMA-1007
    D.3.2Product code [18F]PSMA-1007
    D.3.4Pharmaceutical form Solution for injection/infusion
    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 INNF-18-PSMA-1007
    D.3.9.3Other descriptive nameF-18-PSMA-1007
    D.3.9.4EV Substance CodeSUB194628
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number150
    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
    Colon and gastric cancer patients
    E.1.1.1Medical condition in easily understood language
    Bowel and gastric cancer patients
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    Assess the feasibility of [18F]-PSMA-1007 PET/CT imaging to detect primary colon and gastric cancer.
    E.2.2Secondary objectives of the trial
    Assess association between the in vivo [18F]-PSMA-1007 PET/CT-imaging uptake in the tumor and histopathologic evidence of tumor tissue and PSMA expression determined on the resection specimen.

    Assess the agreement between different preoperative imaging modalities (e.g. [18F]-PSMA-1007 PET/CT-scan, [18F]-FDG-PET/CT, MR imaging, CT imaging, gastroscopy, colonoscopy).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients aged 18 years or older.
    • Diagnosis of primary T3-4N0-2M0-1 colorectal adenocarcinoma (cohort 1) or primary T3-4N0-2M0 gastric carcinoma (cohort 2) and eligible for surgery.
    • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
    • Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
    E.4Principal exclusion criteria
    • Any condition that in the opinion of the investigator could potentially jeopardize the health status of the patient.
    • Women who are pregnant and/or or lactating.
    • Diabetes Mellitus
    • 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.
    • Prior radiotherapy to the abdomen (cohort 1 and 2) and/or thorax (cohort 2).
    • Unacceptable known (clinically significant) cardiovascular or pulmonary disease, renal or liver dysfunction.
    • Known hypersensitivity to drugs comparative to PSMA-1007, or any of their excipients or to any component of [18F]-PSMA-1007.
    • Inability to undergo PET/CT scanning (e.g. claustrophobia, weight limits or inability to tolerate lying for the duration of a PET/CT scan (~30 min).
    • Inability to undergo routine MRI or CT scans as part of the diagnostic work up.
    E.5 End points
    E.5.1Primary end point(s)
    Quantification of the accumulation of [18F]-PSMA-1007 (by using TBR, SUV and/or RUV) in the primary tumor on PET/CT. Tumor imaging is feasible (positive) at a TBR ≥ 2.

    E.5.1.1Timepoint(s) of evaluation of this end point
    At early stopping rule and end of study
    E.5.2Secondary end point(s)
    Assess agreement between PET/CT-imaging signal in the cancer and histopathologic evidence of cancer and PSMA expression by the cancer cells or endothelial cells of newly formed capillaries.

    Assess the agreement between different preoperative imaging modalities (e.g. [18F]-PSMA-1007 PET/CT-scan, [18F]-FDG-PET/CT, MR imaging, CT imaging, gastroscopy, colonoscopy).
    E.5.2.1Timepoint(s) of evaluation of this end point
    At early stopping rule and end of study
    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 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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    [18F]FDG-PET
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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
    In case of enacting of the early stopping rule, otherwise after last subject inclusion.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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: 20
    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 state20
    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
    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 Decision2019-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-22
    P. End of Trial
    P.End of Trial StatusOngoing
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