E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Lymph node metastases in rectal cancer |
lymfekliermetastasen in rectumkanker |
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E.1.1.1 | Medical condition in easily understood language |
Lymph node metastases in rectal cancer |
lymfeklieruitzaaiingen in rectumkanker |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
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 |
Validate the results of Nano MRI (use of MRI in combination with ferumoxtran) with actual pathology in rectal cancer |
Valideren van de resultaten van Nano MRI met pathologie bij rectumcarcinoom |
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E.2.2 | Secondary objectives of the trial |
compare 7 tesla and 3 tesla MRI for lymph node detection in locally advanced rectal cancer |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
General criteria: - Age > 18 years
Inclusion criteria rectal cancer patients: - Patients with recently histologically proven rectal cancer, who are: o Planned to undergo neoadjuvant radiotherapy 50.4 Gy with concomitant chemotherapy consisting of capecitabin 825-1000 mg/m2 and/or oxaliplatin 85 mg/m² . and o Planned to undergo a total mesorectal excision.
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Algemene criteria: - leeftijd > 18 jaar
- Patienten met recente histologische bewezen rectum carcinoom, die zijn:
o Gepland om neoadjuvante radiotherapie 50.4 Gy met gelijktijdig chemotherapie bestaande uit capecitabine 825-1000 mg/m2 en-of oxaliplatin 85 mg/m² te ondergaan. en o Gepland staan om een totale mesorectale excisie te ondergaan. |
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E.4 | Principal exclusion criteria |
General exclusion criteria:
- Abdominal circumference > 120cm - Pregnancy
- Karnofsky score <= 70
- Contraindications for 3T MRI: o Epilepsy o Inability to provide informed consent o Metal implants that are not compatible with 3 Tesla MRI
- Contraindications to USPIO based contrast agents: o prior allergic reaction to ferumoxtran-10 or any other iron preparation o prior allergic reaction contributed to dextran or other polysaccharide, in any preparation o prior allergic reaction to contrast media of any type o hereditary hemochromatosis, thalassemia, sickle cell anemia;
- Contraindications to bisacodyl or butylscopolamine: o cardiac arrhythmia, o myasthenia gravis, o urinary retention, o gastrointestinal stenoses, o kidney failure o glaucoma,
- Inflammatory diseases of the abdomen (such as Crohn’s disease)
- Previous abdominal surgery or radiotherapy
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Algemene exclusie criteria: - Buikomtrek > 120cm
- Zwangergschap
- Karnofsky score <= 70
- Contraindicaties for 3T MRI: o Epilepsie o Niet in staat om informed consent te geven o Metalen implanten die niet 3 Tesla MRI compatibel zijn
- Contraindicaties voor USPIO contrastmiddelen: o Eerdere allergische reactie op ferumoxtran-10 of een ander ijzer preparaat o Eerdere allergische reactie op dextran of een andere polysaccharide, in elke bereiding o Eerdere allergische reactie op contrast medium van elk type o Erfelijke hemochromatosis, thalassemie of sikkelcel anemie;
- Contraindicaties voor bisacodyl or butylscopolamine: o hartritmestoornissen, o myasthenia gravis, o urine retentie, o gastrointestinale stenose, o nierinsufficientie o glaucoom,
- Inflammatoire buikziekten, zoals ziekte van Crohn - Eerder abdominale chirurgie of radiotherapie |
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E.5 End points |
E.5.1 | Primary end point(s) |
Sensitivity and specificity of 7T MRI scans with Sinerem enhancement for lymph node metastasis detection. We will make a subdivision into small (<5mm) and large nodes(≥5mm). |
Sensitiviteit en specificiteit van 3T en 7T MRI scans met ferumoxtran-10 voor de lymfeklier metastase detectie na chemoradiatie in lokaal uitgebreide rectum carcinoom patienten. Er zal een subdivisie gemaakt worden in kleine (<5mm) en grote lymfeklieren (≥5mm). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1-2 weeks before total mesorectal excision. |
1-2 weken voor totale mesorectale excisie |
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E.5.2 | Secondary end point(s) |
comparison between 3T and 7T on sensitivity and specificity |
vergelijk tussen 3T en 7T wat betreft sensitiviteit en specificiteit |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1-2 weeks before total mesorectal excision. |
1-2 weken voor totale mesorectale excisie |
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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 | No |
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 | 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.8.5 | 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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |