E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Lymph node metastases in patients with squamous cell head and neck carcinoma. |
Lymfekliermetastasen bij patiënten met plaveiselceltumoren van het hoofd-hals gebied. |
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E.1.1.1 | Medical condition in easily understood language |
Lymph node metastases in patients with head and neck cancer. |
Lymfeklieruitzaaiingen bij patiënten met hoofd-hals kanker. |
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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 | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To validate nano‐MRI with histopathology for the detection of lymph node metastases in head‐and‐neck squamous cell carcinoma. |
Valideren van nano-MRI met histopathologie voor het opsporen van lymfekliermetastasen bij plaveiselceltumoren van het hoofd-hals gebied. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Males and females aged >18 years.
- Patients with histopathologically proven cT0-4N0-2M0 squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or unknown primary.
- Patients planned for a neck dissection.
- Patients providing informed consent |
- Mannen en vrouwen, leeftijd > 18 jaar
- Patiënten met een histologisch bewezen cT0-4N0-2M0 plaveiselcelcarcinoom van de mondholte, orofarnx, hypofarynx of van onbekende origine.
- Patiënten die een halsklierdissectie ondergaan.
- Patiënten die toestemming geven voor deelname |
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E.4 | Principal exclusion criteria |
- Patients who underwent radio- and/or chemotherapy to the neck before surgery.
- Patients who had a previous lymphadenectomy in the head and neck region.
- Patients who are pregnant and/or breast-feeding.
Patients with contraindications to MRI:
- Epilepsy
- Metallic implants
Patients with contraindications to ferumoxtran-10:
- 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 |
- Patiënten die radio- en/of chemotherapie hebben ondergaan voorafgaand aan de halsklierdissectie.
- Patiënten die een eerdere halsklierdissectie hebben gehad in het verleden.
- Patiënten die zwanger zijn of borstvoeding geven.
Patiënten met contra-indicaties voor MRI:
- epilepsie
- metalen implantaten
Patiënten met contra-indicaties voor ferumoxtran-10:
- eerdere allergische reactie op ferumoxtran-10 of een ander ijzerhoudend (contrast)middel
- eerdere allergische reactie op dextran of een andere polysaccharide
- eerder allergische reactie op een contrastmiddel
- hereditaire hemochromatose, thalassemie, sikkelcelanemie |
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E.5 End points |
E.5.1 | Primary end point(s) |
Sensitivity and specificity of nano-MRI MRI in detection of (subclinical) lymph node metastases in head-and-neck carcinoma. |
Sensitiviteit en specificiteit van nano-MRI voor het opsporen van (occulte) lymfekliermetastasen bij hoofd-hals kanker. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
One day after intravenous administration of ferumoxtran-10 using MRI. |
Een dag na intraveneuze toediening van ferumoxtran-10 gebruikmakend van MRI. |
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E.5.2 | Secondary end point(s) |
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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.8.3 |
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
|
LVLS |
Laatste bezoek van laatste patiënt. |
|
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 | 6 |
E.8.9.1 | In the Member State concerned days | |