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    Summary
    EudraCT Number:2021-000456-19
    Sponsor's Protocol Code Number:BC-09501
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-09-29
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-000456-19
    A.3Full title of the trial
    Use of 18F-PSMA-11 PET for detection of lesions in iodine refractory thyroid cancers
    Gebruik van 18F-PSMA PET voor detectie van letsels bij iodiumrefractaire schildkliertumoren.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Use of 18F-PSMA-11 PET for detection of lesions in iodine refractory thyroid cancers
    A.4.1Sponsor's protocol code numberBC-09501
    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 Ghent
    B.1.3.4CountryBelgium
    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 supportCancer Research Institute Ghent (CRIG)
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportUniversity Hospital Ghent
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Ghent
    B.5.2Functional name of contact pointHIRUZ CTU
    B.5.3 Address:
    B.5.3.1Street AddressC. Heymanslaan 10
    B.5.3.2Town/ cityGhent
    B.5.3.3Post code9000
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3293320500
    B.5.5Fax number+3293320520
    B.5.6E-mailhiruz.ctu@uzgent.be
    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-11
    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[18F]PSMA-11
    D.3.9.3Other descriptive name[18F]AlF-HBED-CC-PSMA
    D.3.10 Strength
    D.3.10.1Concentration unit GBq/ml gigabecquerel/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.1 to 2.5
    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 with a iodine refractory thyroid carcinoma, who received an 18F -FDG PET/CT scan in routine clinical practice.
    E.1.1.1Medical condition in easily understood language
    Patients with a iodine refractory thyroid carcinoma, who received an 18F -FDG PET/CT scan in routine clinical practice.
    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
    Demonstrate uptake of 18F-PSMA-11 in lesions in a radio-active iodine refractive thyroid carcinoma (RAI-RTC), either local recurrent disease, lymph nodes or distant metastasis.
    E.2.2Secondary objectives of the trial
    - Perform a semi-quantitative analysis of radiotracer uptake in lesions.
    - Perform a lesion detection rate analysis on organ level.
    - Compare uptake of 18F-PSMA-11 in these patients to the uptake of 18F-FDG, on a lesion basis as well as on a patient basis.
    - Evaluate the sufficiency of uptake of 18F-PSMA-11 to consider therapy with 177Lu-PSMA in a subset of patients.
    - Compare the histological expression of PSMA on the primary tumor with the uptake of lesions on PSMA PET.
    - Analyse the correlation between the serum level of PSMA and the uptake on PSMA PET.
    - Compare the histological expression of PSMA on the primary tumor with the serum level of PSMA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient is 18 years or older.
    - Signed Informed Consent.
    - Subject is diagnosed with a histologically confirmed differentiated thyroid carcinoma, that is considered RAI refractory.
    - Subject should have a routine clinical 18F-FDG PET/CT performed within two months prior to the study scan.
    - Female patients should be either post-menopausal, surgically sterile, or using effective contraceptive methods (failure rate less than 1% per year when used consistently and correctly: combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence).
    E.4Principal exclusion criteria
    - Patient has known other active malignancy.
    - Patient is potentially pregnant (urinary hCG test can be performed in case of doubt) or breastfeeding.
    - Patient is mentally or legally incapacitated.
    E.5 End points
    E.5.1Primary end point(s)
    Confirmation in PET-scan that lesions in RAI-RTC show uptake of 18F-PSMA-11, above background activity in the bloodpool.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 60 minutes (+- 5 minutes) post injection
    E.5.2Secondary end point(s)
    - Perform a semi-quantitative analysis of radiotracer uptake in lesions.
    o Standard uptake value (SUV) measurements will be performed: SUVmax for lesions and SUVmean for background areas.
    o Total metabolic tumor volume (MTV) measurements based on 41% of SUVpeak.
    - Perform a lesion detection rate analysis on organ level.
    o Lesion count per organ
    - Compare uptake of 18F-PSMA-11 in these patients to the uptake of 18F-FDG, on a lesion basis.
    o Comparison of SUV values of each lesion in both tracers.
    o Evaluation if any lesions are only visible with either FDG or PSMA.
    - Evaluate the sufficiency of uptake of 18F-PSMA-11 to consider therapy with 177Lu-PSMA in a subset of patients.
    o Lesions have an SUVmax value of at least 1.5 times the uptake in the liver and there is no major tumor load visible on FDG PET that is not PSMA avid. Criteria used by Hofmann et al. in a phase 2 study for prostate cancer (Hofman MS)
    - Compare the histological expression of PSMA on already available tumor samples with the uptake of lesions on PSMA PET.
    o Expression of PSMA defined as negative, score 0 (0-5% expression), moderately positive, score 1 (6-50%) or highly positive, score 2 (51-100%)
    o Comparison of this score with MTV values of PSMA PET.
    - Analyse the correlation between the serum level of PSMA and the uptake on PSMA PET.
    o Comparison of the value in the serum PSMA with MTV values of PSMA PET, grouped in male and female patient population (Beckett ML)
    - Compare the histological expression of PSMA on the primary tumor with the serum level of PSMA.
    o Expression of PSMA defined as negative, score 0 (0-5% expression), moderately positive, score 1 (6-50%) or highly positive, score 2 (51-100%)
    o Comparison of this score with PSMA values in the serum.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 60 minutes (+- 5 minutes) post injection.
    Analyses will be done within max. 1 year after LSLV.
    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 Yes
    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.8.2.4Number of treatment arms in the trial1
    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
    1 year after LSLV.
    To perform all histological analysis on the available tumor samples.
    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 months8
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 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)
    Standard of Care
    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 Decision2021-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-07-18
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