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    Summary
    EudraCT Number:2018-000726-63
    Sponsor's Protocol Code Number:PHPT2018
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-06-06
    Trial results View 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 ConcernedDenmark - DHMA
    A.2EudraCT number2018-000726-63
    A.3Full title of the trial
    Pre- and Postoperative Imaging and Monitoring of Patients with Primary Hyperparathyroidism:

    Preoperative imaging in primary hyperparathyroidism using dual-isotope subtraction scintigraphy (SPECT/CT) and 11C-Choline PET/CT
    Hyperparathyroidisme: Monitorering af patienter med primær hyperparathyroidisme før og efter operation samt diagnostiske metoder:

    Primær hyperparathyroidisme: Præoperativ diagnostik med dobbelt-isotop subtraktions skintigrafi (SPECT/CT) og 11C-Cholin PET/CT
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Imaging of parathyroid glands prior to surgical removal in patients with parathyroid disease.
    Billeddannelse af biskjoldbruskkirtlerne forud for kirirgusk fjernelse af disse hos patienter med biskjoldbruskkirtelsygdom.
    A.4.1Sponsor's protocol code numberPHPT2018
    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 SponsorDepartment of Clinical Physiology and Nuclear Medicine, Herlev and Gentofte Hospital
    B.1.3.4CountryDenmark
    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 supportDepartment of Clinical Physiology and Nuclear Medicine, Herlev and Gentofte Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Clinical Physiology and Nuclear Medicine, Herlev and Gentofte Hospital
    B.5.2Functional name of contact pointClinical Trial Info, PhD student
    B.5.3 Address:
    B.5.3.1Street AddressHerlev Ringvej 75
    B.5.3.2Town/ cityHerlev
    B.5.3.3Post code2730
    B.5.3.4CountryDenmark
    B.5.6E-mailheh-fysiologi@regionh.dk
    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 name11C-Choline "Herlev" Injection fluid
    D.3.2Product code 27415258713
    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 INN11C-Choline "Herlev" injection fluid
    D.3.9.1CAS number 62-49-7
    D.3.9.3Other descriptive nameCHOLINE
    D.3.9.4EV Substance CodeSUB13349MIG
    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 2.0
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Sodium Iodide
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare B.V.
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical 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 INNSodium Iodide
    D.3.9.1CAS number 41927-88-2
    D.3.9.3Other descriptive nameSODIUM IODIDE (123 I)
    D.3.9.4EV Substance CodeSUB15296MIG
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number11.1 to 14.8
    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.IMP: 3
    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 Yes
    D.2.1.1.1Trade name Technescan Sestamibi
    D.2.1.1.2Name of the Marketing Authorisation holderMallinckrodt Medical B.V.
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical 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 INNTECHNETIUM (99MTC) SESTAMIBI
    D.3.9.1CAS number 109581-73-9
    D.3.9.4EV Substance CodeSUB10857MIG
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number200 to 700
    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
    Primary hyperparathyroidism
    Primær hyperparathyroidisme
    E.1.1.1Medical condition in easily understood language
    Disease in the parathyroid gland(s) causing an overproduction of parathyroid hormome.
    Sygdom i biskjoldbruskkirtlen(/-rne) som resulterer i en overproduktion af biskjoldbruskkirtlens hormon.
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036693
    E.1.2Term Primary hyperparathyroidism
    E.1.2System Organ Class 100000004860
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this trial is to assess whether the sensitivity and specificity of 11C-Choline PET/CT is comparable to dual-isotope subtraction scintigraphy (SPECT/CT) in the preoperative location of hyperfunctioning parathyroid glands
    Det primære formål med dette forsøg er at undersøge om sensitivtet og specificitet for 11C-Choline PET/CT er sammenlignelig med dobbeltisotop subtraktionsskintigrafi ved præoperativ lokalisationsdiagnostik af hyperfungerende parathyroideavæv
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Version 3
    Date: 23-05-2018
    Title: Preoperative location of parathyroid-adenoma using ultrasound/SPECT/CT fusion – a method study
    Objective: This is an exploratory method study. The primary objective of this trial is to assess whether US fused with SPECT, PET and CT is feasible and if it can contribute information as to the location of a parathyroid adenoma. As such, the primary endpoint is description of the process including challenges as well as helpfulness of the results.
    Version 3
    Dato: 23-05-2018
    Titel: Præoperativ diagnostik med ultralyd fusioneret med SPECT/CT og PET/CT
    Formål: Dette er et eksplorativt metodestudie, og formålet er at vurdere om metoden kan bruges samt beskrive metoden og udfordringer hermed
    E.3Principal inclusion criteria
    Patients diagnosed with primary hyperparathyroidism are eligible for inclusion when referred for dual-isotope subtraction scintigraphy and parathyroidectomy.
    Patienter kan inkluderes når de er diagnosticeret med primær hyperparathyroidisme og henvist til dobbelt-isotop subtraktionsskintigrafi (SPECT/CT) forud for planlagt parathyroidektomi.
    E.4Principal exclusion criteria
    1) The patient does not wish to participate
    2) The patient is unable to give informed consent
    3) The patient is <18 years old
    4) The patient is unable to cooperate e.g. severe claustrophobia
    5) Other reason for secondary osteoporosis (e.g. treatment with glucocorticoids)
    6) Current pregnancy or breastfeeding
    7) Known hypothyroidism
    8) Known cancer (other than basal cell carcinoma)
    9) Hypersensitivity to the reseaerch drug
    1) Patienten ønsker ikke at deltage
    2) Patienten er ikke i stand til at afgive informeret samtykke
    3) Patienten er under 18 år gammel
    4) Patienten kan ikke samarbejde, fx grundet svær klaustrofobi
    5) Anden årsag til sekundær osteoporose (fx langvarrig behandling glucocorticoider)
    6) Aktuel graviditet eller anming
    7) Kendt hypothyroidisme
    8) Kendt cancer (andet end basalcellecarcinom)
    9) Hypersensitivitet overfor forsøgslægemidlet
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of correct 11C-Choline PET/CT assessments compared to the proportion of correct dual isotope subtraction scintigraphy (SPECT/CT) assessments with regard to location of hyperfunctioning parathyroid tissue.
    The surgical result (confirmed by perioperative PTH-measurements and postoperative pathology) will serve as the gold standard.
    Det primære endepunkt er andelen af korrekte 11C-Cholin PET/CT vurderinger i forhold til andelen af korrekt vurderes dobbelt-isotop subtraktionsskintigrafier når det kommer til lokalisation af hyperfungerende parathyroideavæv.
    Det kirurgiske resultat (bekræftet ved patologi og perioperativ PTH-målinger) er guldstandard.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Results will be evaluated after 60, 100 and 200 patients have undergone scintigraphy and PET/CT and possible parathyroidectomy where the removed tissue will be evaluated by a pathologist..
    Resultater evalueres når 60, 100 og 200 patienter har gennemført skintigrafi og PET/CT og mulig parathyroidektomi hvor det fjernede væv undersøges at patolog.
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Preoperative location of parathyroid(s)
    Præoperativ lokalisationsdiagnostik af gll parathyroidea
    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 Yes
    E.8.1.7.1Other trial design description
    Observationelt
    Observational
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Anden billeddannende modalitet (dobbeltisotop subtraktionsskintigrafi, SPECT/CT)
    Other imaging modality (i.e. dual isotope subtraction scintgraphy, SPECT/CT)
    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
    The trial ends when the last patient has undergone both scintigraphy, 11C-Choline PET/CT and surgery and the removed tissue has been evaluated by a pathologist.
    This is nedded in order to ensure results from the gold standard (i.e. surgery)
    Forsøget afsluttes når den sidste patient har gennemført både skintigrafi, 11C-Cholin PET/CT og kirurgi og den bortopererede væv er vurderet af patolog.
    Dette er nødvendigt mhp. at sikre resultatet fra guldstandarden (kirurgi)
    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 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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2018-06-06. Yes
    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 state200
    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
    Ingen
    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 Decision2018-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-04-30
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