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    EudraCT Number:2021-000827-11
    Sponsor's Protocol Code Number:T50/2021
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-04-19
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedFinland - Fimea
    A.2EudraCT number2021-000827-11
    A.3Full title of the trial
    Clinical use of USPIO contrast media in the assessment of pelvic lymph node metastasis in rectal cancer.
    USPIO-varjoaineen kliininen käyttö peräsuolisyövän lantion imusolmukemetastasoinnin arvioinnissa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical use of USPIO magnetic imaging contrast media in the assessment of pelvic lymph node metastasis in rectal cancer patients.
    USPIO-magneettikuvaus varjoaineen kliininen käyttö peräsuolisyövän lantion imusolmukemetastasoinnin arvioinnissa.
    A.4.1Sponsor's protocol code numberT50/2021
    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 SponsorTurku University Hospital
    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 supportSaving Patients' Lives Medical B.V.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTurku University Hospital
    B.5.2Functional name of contact pointDepartment of Radiology
    B.5.3 Address:
    B.5.3.1Street AddressKiinamyllynkatu 4-8
    B.5.3.2Town/ cityTurku
    B.5.3.3Post code20521
    B.5.4Telephone number+358023133950
    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 nameFerrotran Lyophilisate
    D.3.2Product code Ferumoxtran-10
    D.3.4Pharmaceutical form Powder for 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 INNFerumoxtran-10
    D.3.9.1CAS number 189047-99-2
    D.3.9.3Other descriptive nameFERUMOXTRAN-10
    D.3.9.4EV Substance CodeSUB31919
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number210.4
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 No
    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
    Pelvic lymph node metastasis in rectal cancer.
    Lantion alueen imusolmukemetastasointi peräsuolisyövässä.
    E.1.1.1Medical condition in easily understood language
    Pelvic lymph node metastasis in rectal cancer.
    Lantion alueen imusolmukemetastasointi peräsuolisyövässä.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    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
    Assessment of clinical nodal stage (cN-stage) accuracy of Ferumoxtran-10-enhanced (USPIO) Magnetic Resonance Imaging (MRI) compared to histopatologic pN-stage of newly-diagnosed rectal cancer (RC) patients
    Ferumoxtran-10 (USPIO) tehosteisen magneettikuvauksen (MK) kliinisen nodaalisen cN-stage levinneisyysarvion tarkkuus verrattuna histopatologiseen pN-stage levinneisyysarvioon.
    E.2.2Secondary objectives of the trial
    Effect of Ferumoxtran-10-enhanced (USPIO) Magnetic Resonance Imaging (MRI) cN-stage assesment on treatment planning compared to conventrional MRI.
    Ferumoxtran-10 (USPIO) magneettikuvauksen (MK) levinneisyysarvion vaikutus valittuun hoitolinjaan verrattuna perinteiseen magneettikuvaukseen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Voluntarily given and written informed consent.
    Over 18 years of age.
    Newly-diagnosed rectal cancer patients scheduled for direct surgery or short course radiotherapy (SCRT) followed by surgery.
    Vapaaehtoiset henkilöt, joilta saatu kirjallinen suostumus.
    Yli 18-vuotiaat henkilöt.
    Vasta-diagnosoidut peräsuolisyöpäpotilaat, joille suunnitellaan suoraa leikkausta tai lyhyttä sädehoitoa ennen leikkausta
    E.4Principal exclusion criteria
    Metastatic disease or T1-disease.
    Allergy to hypersensitivity to Ferumoxtran-10 or its components.
    Patients with any known history of drug allergy (including hypersensitivity) to other iron products.
    Clinically documented or risk of primary or secondary iron overloading (e.g. history of thalassemia, sickle cell anemia, hereditary hemochromatosis, multiple transfusions with any reason).
    Patients refusing or unable to give informed consent.
    Lactation or pregnant women.
    Women of childbearing potential cannot be included if they dont't take precautions against pregnancy.
    Prior abdominopelvic radiation.
    Prior abdominopelvic malignancies.
    Contraindications for MRI (ie. ferromagnetic metallic implants, claustrophobia, MR-incompatible pacemakers, MR-incompatible prosthetic heart valves, severe obesity etc.).
    Metastaattinen tauti tai T1-tauti.
    Allergia tai yliherkkyys Ferumoxtra-10:lle tai sen ainesosille.
    Allergia tai yliherkkyys muille rautalääkkeille.
    Kliinisesti todettu primaari tai sekundaarinen raudankertymäsairaus tai riski kehittää raudankertymäsairaus (esim. thalasemia, sirppisoluanemia, perinnöllinen hemokromatoosi, toistuvat punasolutipukset syystä riippumatta).
    Ei-täysvaltaiset henkilöt ja tutkittavat, jotka eivät voi antaa suostumusta.
    Imettävät tai raskaana olevan naiset.
    Lisääntymisikäiset naishenkilöt joilla ei ole käytössä olevaa ehkäisyä, eivät voi osallistua tutkimukseen.
    Aikaisempi lantion tai vatsan alueen sädehoito.
    Aikaisempi lantion tai vatsan alueen maligniteetti.
    Vasta-aiheet magneettikuvaukselle (esim. sydämen tahdistin ja muut kehon magneettiset vierasesineet, ahtaanpaikankammo sekä esimerkiksi vaikea liikalihavuus jne).
    E.5 End points
    E.5.1Primary end point(s)
    Accuracy, spesificity and sensitivity of USPIO-MRI.
    USPIO-MRI tarkkuus, spesifisyys ja sensitiivisyys.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After TME-surgery.
    TME-leikkauksen jälkeen.
    E.5.2Secondary end point(s)
    After TME-surgery.
    TME-leikkauksen jälkeen.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 to 4 week after USPIO-MRI.
    1-4 viikkoa USPIO-magneettikuvaksen jälkeen.
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E. description
    USPIO-MK ja perinteinen MK verrattuna histopatologiaan.
    USPIO-MRI and Conventional MRI compared to histopatology
    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
    Sample size is calculated and adjusted to 60. Recruitment phase will take up to years.
    If we need to increase our sample size, the recruitment period might be prolonged.
    Laskelmien ja adjustointien perusteella otoskoko on 60. Rekrytointivaihe voi kestää 3 vuotta.
    Mikäli otoskokoa pitää nostaa, voi rekrytointivaihe pidentyä.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state60
    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)
    Post trial treatment won't differ from expected normal treatment.
    Tutkimukseen osallistuminen ei vaikuta valittuun hoitolinjaan tai seurantaan.
    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 Decision2022-09-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-21
    P. End of Trial
    P.End of Trial StatusOngoing
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