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    Summary
    EudraCT Number:2016-005182-31
    Sponsor's Protocol Code Number:RCCSCAN
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-01-10
    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 ConcernedSweden - MPA
    A.2EudraCT number2016-005182-31
    A.3Full title of the trial
    "An exploratory study regarding the use of the biomarker DAT for image diagnosis of clear cell renal cell carcinoma"
    ”En explorativ studie avseende användning av biomarkören DAT för bilddiagnostik av klarcellig njurcancer”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Diagnostic imagning for clear cell renal cell carcinoma
    Bilddiagnostik för klarcellig njurcancer
    A.3.2Name or abbreviated title of the trial where available
    RCCSCAN
    A.4.1Sponsor's protocol code numberRCCSCAN
    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 SponsorLund University
    B.1.3.4CountrySweden
    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 supportLund University
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportAkuru Pharma AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLund University
    B.5.2Functional name of contact pointHåkan Axelson
    B.5.3 Address:
    B.5.3.1Street AddressMedicon Village, Scheelevägen 2
    B.5.3.2Town/ cityLund
    B.5.3.3Post code22363
    B.5.3.4CountrySweden
    B.5.4Telephone number+460462226434
    B.5.6E-mailhakan.axelson@med.lu.se
    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 Yes
    D.2.1.1.1Trade name DaTSCAN
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    Renal Cell Carcinoma
    Njurcancer
    E.1.1.1Medical condition in easily understood language
    Kidney cancer
    Njurcancer
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10023400
    E.1.2Term Kidney cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to investigate whether DaTSCAN with subsequent SPECT can detect elevated DAT levels in at least a lesion identified with CT in patients with clear cell renal cell carcinoma, as assesed by pathologist?

    DaTSCAN signal will be seen as positive, displaying intensity ≥3ggr higher than the background and correlating anatomically with at least one lesion found with CT.

    DaTSCAN is used routinely to detect the loss of dopaminergic neurons in the striatum of patients with clinically uncertain Parkinsonian Syndromes. The active substance in DaTSCAN, Ioflupane specifically binds to DAT. By analyzing the focal uptake of Ioflupane (123I) with SPECT / CT the progression of the disease may be clarified. In light of our findings that clear cell renal cancer express significantly elevated levels of DAT, we postulate that DaTSCAN can be used for detection of clear cell ranal cell carcinoma.
    • Kan DaTSCAN med efterföljande SPECT detektera förhöjda DAT nivåer i minst en lesion identifierad med CT hos patienter med PAD-verifierad klarcellig njurcancer?

    DaTSCAN signal kommer att ses som positiv där den visar ≥3ggr högre intensitet än bakgrund och korrelerar anatomiskt med minst en lesion funnen med CT.

    DaTSCAN används rutinmässigt för att detektera förlust av dopaminerga nervceller i striatum hos patienter med kliniskt oklara Parkinsonsyndrom. Det aktiva ämnet i DaTSCAN, Ioflupane injiceras venöst och binder specifikt till DAT. Genom att analysera fokalt upptag av Ioflupane (123I) med SPECT/CT kan progressionen av sjukdomen klargöras. I ljuset av vårt fynd att klarcellig njurcancer uttrycker kraftigt förhöjda nivåer av DAT, postulerar vi att DaTSCAN kan användas för detektion av njurtumörer av klarcellig subtyp.
    E.2.2Secondary objectives of the trial
    The exploratory objective is to investigate whether:

    • DaTSCAN with subsequent SPECT, by detecting elevated levels of DAT in clear cell renal cancer, can be used to distinguish clear cell renal cancer from other subtypes of renal cancer such as papillary renal cell cancer, chromofob kidney cancer and benign tumors such as oncocytoma?

    • Surgically removed DaTSCAN positive lymph nodes exhibit infiltration of clear cell renal cell carcinoma cells, regardless of the CT status?

    • DAT-mRNA expression in primary tumor correlate with DaTSCAN signal where the surgically removed tumor material with high DaTSCAN intensity also exhibit high mRNA levels of DAT?
    Explorativa frågeställningar:
    • Kan DaTSCAN efterföljd av SPECT, genom att detektera förhöjda nivåer av DAT i klarcellig njurcancer, användas för att särskilja klarcellig njurcancer från andra subtyper av njurcancer så som papillär njurcancer, chromofob njurcancer samt benigna tumörer som t.ex. oncocytom?

    • Uppvisar bortopererade DaTSCAN positiva lymfkörtlar infiltration av klarcelliga njurcancerceller, oberoende av CT-status?

    • Korrelerar mRNA-uttrycket i primärtumören med DaTSCAN-signalen där bortopererat tumörmaterial med hög DaTSCAN intensitet också uppvisar höga mRNA nivåer av DAT?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -suspected kidney cancer diagnosis
    -suspected spread of the cancer
    -the patient is scheduled for surgery alternatively biopsy of kidney tumor
    -the patient is 18 years or older
    -the patient has given their consent to participate in the study
    -female patient of reproductive age displays negative pregnancy test
    Patienten/forskningspersonen har av läkare misstänkt njurcancerdiagnos
    Patienten/forskningspersonen har av läkare misstänkt sjukdomsspridning
    Patienten/forskningspersonen är planerad för operation alternativt biopsering av njurtumör
    Patienten/forskningspersonen är 18 år eller över
    Patienten/forskningspersonen har givit sitt samtycke till att deltaga i studien
    Kvinnlig patient/forskningsperson i fertil ålder uppvisar negativt graviditetstest
    E.4Principal exclusion criteria
    -known or suspected allergy to the active substance in DaTSCAN, ioflupane or any of the following ingredients:
    • Sodium acetate
    • Acetic acid
    • Ethanol

    -the patient suffers from moderate to severe liver disease or cholestasis with liver enzymes (total bilirubin, AST, ALT, ALP, GGT)> 2 times the upper limit

    -the patient suffers from moderate to severe renal impairment and exhibits GFR <40

    -the patient is medicated for Parkinson's disease

    -the patient is medicated with any of the following medications:
    • Amphetamine
    • benzatropine
    • Buproprion
    • Cocaine
    • mazindol
    • Methylphenidate
    • Phentermine
    • Sertraline
    • levodopa (Sinemet, Pharma Copa, Atamet, Stalevo, Madopar, Prolopa)
    Controlled by review of medical records and anamnesis

    -the patient is /or plans to become pregnant. Controlled by negative pregnancy test.

    -breastfeeding

    -the patient suffers from mental inability, unwillingness or language difficulties resulting difficulty in understanding the meaning of taking part in the study
    Patienten/forskningspersonen har känd eller misstänkt allergi mot det aktiva ämnet i DaTSCAN, ioflupan eller mot något av följande hjälpämnen:
    • Natriumacetat
    • Ättiksyra
    • Etanol

    Patienten/forskningspersonen lider av måttlig till grav leversjukdom eller gallstassjukdom med levervärden (totalt billirubin, ASAT, ALAT, GT, ALP) >2 gånger övre gränsvärdet

    Patienten lider av måttlig till grav njurfunktionsnedsättning och uppvisar eGFR<40 mL/min/1.73m2


    Patienten/forskningspersonen medicineras för Parkinsons sjukdom

    Patienten/forskningspersonen medicineras med något av följande läkemedel:
    • Amfetamin
    • Bensatropin
    • Buproprion
    • Kokain
    • Mazindol
    • Metylfenidat
    • Fentermin
    • Sertralin
    • L-DOPA (Sinemet, Pharmacopa, Atamet, Stalevo, Madopar, Prolopa)
    Kontrolleras med journalgenomgång och anamnes

    Patienten/forskningspersonen är eller planerar att bli gravid

    Patienten/forskningspersonen ammar

    Patienten/forskningspersonen lider av mental oförmåga, ovilja eller språksvårigheter som medför svårighet att förstå innebörden av att delta i studien
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is to investigate whether tumors detected by CT display DaTSCAN positivity in patients with verified clear cell renal cell carcinoma.
    DaTSCAN signal will be seen as positive when displaying ≥3ggr higher intensity than the background and correlating anatomically with at least one lesion found with CT.
    Primär endpoint är att undersöka om tumörer detekterade med CT uppvisar DaTSCAN positivitet hos patienter som har PAD-verifierad klarcellig njurcancer.
    DaTSCAN signal kommer att ses som positiv där den visar ≥3ggr högre intensitet än bakgrund och korrelerar anatomiskt med minst en lesion funnen med CT.
    E.5.1.1Timepoint(s) of evaluation of this end point
    All patients will be consequtively evaluated after completed examination. The inklusion of the 10 patients is expected to last around 10 months, and the results from the last enrolled patient is expected to be obtained one year after the initiation of the trial.
    Varje patient kommer att utvärderas kontinuerligt efter fullföljd undersökning. Inklusionen av de tio patienterna kommer att ske löpande under ca 10 månader. Resultaten från den sista inkluderade patienten beräknas fås ett år efter studiestart.
    E.5.2Secondary end point(s)
    The exploratory parameters will be:
    • DaTSCAN displays no positive signal in CT lesions in research subjects with tumors classified as non-clear cell renal cell carcinoma by the pathologist.
    • DaTSCAN positive lymph nodes are infiltrated by clear cell renal cell carcinoma cells.
    • mRNA levels of DAT in the primary tumor correlates with DaTSCAN signal from the primary tumor and tumors with high DaTSCAN intensity exhibit high levels of DAT mRNA.
    Explorativa effektparametrar kommer att vara:
    • DaTSCAN uppvisar ingen positiv signal i CT-lesioner hos forskningspersoner med tumörer som av patolog klassats som icke-klarcellig njurcancer.
    • DaTSCAN-positiva lymfkörtlar är infiltrerade av klarcelliga njurcancerceller.
    • mRNA nivåer av DAT i primärtumör korrelerar med DatSCAN signalen från primärtumören och tumörer med hög DaTSCAN intensitet uppvisar höga nivåer av DAT-mRNA.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All patients will be consequtively evaluated after completed examination. The inklusion of the 10 patients is expected to last around 10 months, and the results from the last enrolled patient is expected to be obtained one year after the initiation of the trial.
    Varje patient kommer att utvärderas kontinuerligt efter fullföljd undersökning. Inklusionen av de tio patienterna kommer att ske löpande under ca 10 månader. Resultaten från den sista inkluderade patienten beräknas fås ett år efter studiestart.
    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 Yes
    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 study will be completed when the following criteria are fulfilled:
    • All available samples from patients whose tissue is included in biobank under authorization number LU680-08 and LU289-07, analyzed for the mRNA levels of DAT.
    • The pahological assessment of the tumor from the last enrolled patient has been received
    Studien kommer att avslutas när följande är kriterier är uppfyllda:
    • Alla tillgängliga prover från patienter vars vävnad inkluderats i biobank enligt tillståndsnummer LU680-08 and LU289-07, analyserats med avseende på mRNA nivåer av DAT.
    • Den sista inkluderade patienten har fått svar från PAD.

    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 2017-01-10. 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 state10
    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
    Inga
    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 Decision2017-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-12
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