E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Detection of locoregional lymph node metastases in patients with resectable esophageal carcinoma |
Detectie van locoregionale lymfekliermetastasen bij patiënten met opereerbare slokdarmkanker |
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E.1.1.1 | Medical condition in easily understood language |
esophaguscarcinoom |
slokdarmkanker |
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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 | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the feasibility and diagnostic accuracy of nano-MRI in the evaluation of locoregional lymph nodes metastases in patients with esophageal cancer whom underwent nCRT and study the effect of nCRT on the detection of locoregional lymph nodes metastases with nano-MRI. |
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E.2.2 | Secondary objectives of the trial |
- Diagnostic accuracy of the nano-MRI under anesthesia and controlled mechanical ventilation motion in detecting metastases in locoregional lymph nodes in patients with esophageal cancer whom underwent nCRT - Diagnostic accuracy of the nano-MRI in detecting metastases in locoregional lymph nodes ex-vivo after nCRT - Identify the effect of CRT on the detection of lymph nodes metastases with nano-MRI - Identify the quantitative effect of anesthesia and controlled mechanical ventilation motion MRI compared with ‘breathhold’ MRI. - Compare the diagnostic accuracy of nano-MRI with clinical staging results of primary esophageal cancer (CT, PET, EUS)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients with recently biopsy proven esophageal cancer, who are planned to undergo a esophagectomy with nCRT • Patients with suspected lymph nodes metastases on EUS or CT before nCRT • Age > 18 years • Providing informed consent
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E.4 | Principal exclusion criteria |
• Unable to provide informed consent • Known pregnancy or breastfeeding • Contra-indications for MRI - Epilepsy - Metal implants that are not compatible with MRI • Contra-indications for USPIO based contrast agents - Prior allergic reaction to ferumoxtran-10 or any other iron preparation - Prior allergic reaction contributed to dextran or other polysaccharide, in any preparation - Prior allergic reaction to contrast media of any type - Hereditary hemochromatosis, thalassemia, sickle cell anemia - Known liver or renal insufficiency
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E.5 End points |
E.5.1 | Primary end point(s) |
Diagnostic accuracy of nano-MRI in detecting of locoregional lymph nodes metastases |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Diagnostic accuracy of ex-vivo nano-MRI in detecting locoregional lymph nodes metastases with ‘breathhold’
- Diagnostic accuracy of ex-vivo nano-MRI in detecting locoregional lymph nodes metastases with
- Diagnostic accuracy of ex-vivo nano-MRI in detecting locoregional lymph nodes metastases
- Effect of locoregional lymph nodes metastases before nCRT
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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.8.2.4 | 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
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LVLS |
Laatste bezoek van laatste patiënt |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |