E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients of both gender are eligible for this study in case they present with the diagnosis of a primary squamous cell carcinoma of the head & neck after Magnevist-enhanced MRI, are scheduled for tumor biopsy or tumor surgery for clinical reasons, and meet all in- and exclusion criteria. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060121 |
E.1.2 | Term | Squamous cell carcinoma of head and neck |
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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 |
to assess the feasibility of perfusion measurements (permeability-surface product) with Vasovist-enhanced MR in tumors of the head and neck using immunohistochemistry of tumor tissue as the SOR |
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E.2.2 | Secondary objectives of the trial |
to compare further parameters of tumor perfusion (extravascular extracellular volume, blood flow, intravascular blood volume, mean transit time) with parameters of microvascular density in immunohistochemistry
to compare the intravascular contrast agent Vasovist and the conventional contrast agent Magnevist with regard to their capability to assess tumor perfusion
to assess the safety of Vasovist |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age: between 18 and 78 years 2. Primary squamous cell carcinoma of the epi-, oro-, hypopharynx or larynx considered for surgical resection or tumor biopsy within 21 days after Vasovist-enhanced MRI 3. Magnevist-enhanced MRI of the tumor in the head & neck region performed for clinical reasons within 3 days before the planned Vasovist-enhanced MRI 4. Willing and able to undergo all study procedures 5. Has personally provided written informed consent
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E.4 | Principal exclusion criteria |
1. Secondary cancer or history of cancer other than squamous cell carcinoma of the head & neck 2. Patients presenting with a contraindication to MRI such as pacemaker, aneurysm clip, or severe claustrophobia 3. History of severe allergic reaction or allergic reaction to MR contrast media 4. Patients requiring emergency treatment 5. Allergy to any of the ingredients of Vasovist 6. Patients with moderate to severe renal impairment (GFR below 60 mL/min/1.73 m2 according to MDRD or Cockcroft-Gault formula using a blood creatinine value determined within 3 days before contrast agent administration) 7. Pregnant and nursing woman (negative pregnancy test required in women of child-bearing potential – performed within 2 hours before the MR examination) 8. Having been previously enrolled in this study 9. Participating in another clinical trial
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point is the permeability-surface product as calculated from a distributed parameter analysis. |
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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 | Yes |
E.6.5 | Efficacy | Yes |
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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
intra-individual comparison |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
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 | Information not present in EudraCT |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 16 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 16 |