E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pelvic lymph node metastasis in rectal cancer. |
Lantion alueen imusolmukemetastasointi peräsuolisyövässä. |
|
E.1.1.1 | Medical condition in easily understood language |
Pelvic lymph node metastasis in rectal cancer. |
Lantion alueen imusolmukemetastasointi peräsuolisyövässä. |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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.2.2 | Secondary 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.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.4 | Principal 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.5.1 | Primary end point(s) |
Accuracy, spesificity and sensitivity of USPIO-MRI. |
USPIO-MRI tarkkuus, spesifisyys ja sensitiivisyys. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After TME-surgery. |
TME-leikkauksen jälkeen. |
|
E.5.2 | Secondary end point(s) |
After TME-surgery. |
TME-leikkauksen jälkeen. |
|
E.5.2.1 | Timepoint(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.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
USPIO-MK ja perinteinen MK verrattuna histopatologiaan. |
USPIO-MRI and Conventional MRI compared to histopatology |
|
E.8.2.4 | Number of treatment arms in the trial | 1 |
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.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |