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    Summary
    EudraCT Number:2022-000123-20
    Sponsor's Protocol Code Number:202200014
    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:2022-08-05
    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 number2022-000123-20
    A.3Full title of the trial
    Prospective, single-centre, feasibility study to evaluate the use of 18F-PSMA PET/CT in patients with biochemically active medullary thyroid cancer.
    Prospectieve, single-centre studie om de waarde van de 18F-PSMA PET/CT bij patienten met biochemisch actief medullair schildklierkanker te onderzoeken.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the value of the PSMA body scan in patients with medullary thyroid cancer.
    Onderzoek naar de waarde van de PSMA lichaamsscan bij patienten met medullair schildklier kanker.
    A.3.2Name or abbreviated title of the trial where available
    MIMETIC
    MIMETIC
    A.4.1Sponsor's protocol code number202200014
    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 Medical Centre Groningen
    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 supportUniversity Medical Centre Groningen
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Centre Groningen
    B.5.2Functional name of contact pointDepartment of Nuclear Medicine
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713 GZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31503613541
    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[18F]PSMA-1007
    D.3.2Product code Not applicable
    D.3.4Pharmaceutical form Solution for 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 INN[18F]-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 typerange
    D.3.10.3Concentration number125 to 450
    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
    The disease we will be studying is medullary thyroid carcinoma. This type of thyroid carcinoma constitutes approximately 10% of all thyroid cancers. Treatment consists of a total thyroidectomy and central lymph node compartment dissection, possibly with additional lateral neck dissection depending on disease extent. To establish disease extent at diagnosis or to evaluate for progression, PET imaging is used. This study aims to identify whether the 18F-PSMA tracer could be used for this.
    E.1.1.1Medical condition in easily understood language
    Medullary thyroid cancer.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate whether the 18F-PSMA tracer is capable of detecting medullary thyroid carcinoma lesions in patients with biochemically active and cytological/histological proven medullary thyroid cancer.
    E.2.2Secondary objectives of the trial
    • To compare the patient-based, regional-based and lesion-based sensitivity of 18F-PSMA PET/CT with the 18F-FDG PET/CT in patients with MTC.
    • To perform a quantitative comparison of tracer uptake (18F-FDG versus 18F-PSMA) in MTC lesions (using Standardized Uptake Values).
    • To evaluate the association between 18F-PSMA uptake on PET scanning and clinical parameters.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following inclusion criteria:
    - At least 18 years of age
    - Histological or cytological proven MTC
    - Biochemical evidence of disease activity (elevated/increasing calcitonin and/or CEA)
    - Clinical indication for an 18F-FDG PET/CT
    - Able to follow instructions to participate in the study
    - Able to give informed consent
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    - Patients with prostate cancer or renal cell carcinoma
    - Pregnant patients
    - Recent neck surgery (<3 months ago)
    E.5 End points
    E.5.1Primary end point(s)
    The performance of 18F-PSMA PET for the indication medullary thyroid carcinoma. This will be evaluated through the following parameters:
    - Patient-based sensitivity of 18F-PSMA PET/CT for MTC
    - Lesion-based sensitivity of 18F-PSMA PET/CT for MTC
    - Region-based sensitivity of 18F-PSMA PET/CT for MTC
    E.5.1.1Timepoint(s) of evaluation of this end point
    An interim analysis will be performed after 5 patients.

    The final analysis will take place after all 15 patients have undergone the 18F-PSMA PET/CT and 18F-FDG PET/CT.
    E.5.2Secondary end point(s)
    - Comparison of the performance of the 18F-PSMA PET/CT and the 18F-FDG PET/CT in terms of:
    o Patient-based sensitivity
    o Lesion-based sensitivity
    o Region-based sensitivity
    - Quantification of:
    o 18F-FDG uptake in tumor lesions (expressed as Standardized Uptake Values)
    o 18F-PSMA uptake in tumor lesions (expressed as Standardized Uptake Values)
    o Comparison of the 18F-FDG uptake and 18F-PSMA uptake in tumor lesions (comparison of Standardized Uptake Values)
    - Association between 18F-PSMA uptake in tumor lesions (expressed as Standardized Uptake Values) and clinical parameters (see below).
    E.5.2.1Timepoint(s) of evaluation of this end point
    After all patients have undergone the 18F-PSMA PET/CT and 18F-FDG PET/CT.
    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 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
    We intend to include 15 patients. Therefore, the study will end when the last patient, number 15, has undergone the 18F-PSMA PET/CT.
    However, an interim analysis will be performed after 5 patients. If there is no 18F-PSMA uptake in MTC lesions, we will terminate the study. If there is uptake in (a) lesion(s) suspicious for MTC on 18F-PSMA PET/CT imaging, we will continue inclusion until 15 patients have been included.
    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)
    Normal follow-up and treatment. No special plans for treatment or care after the subject has ended the participation in the trial.
    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 Decision2022-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-20
    P. End of Trial
    P.End of Trial StatusOngoing
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