E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with primary diagnosis of non small cell lung cancer considered for surgical resection |
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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 | 10025044 |
E.1.2 | Term | Lung cancer |
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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 value of Vasovist-enhanced MRI for N-staging in lung cancer in comparison to 18F FDG PET/CT |
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E.2.2 | Secondary objectives of the trial |
To assess the value of Vasovist®-enhanced MRI for T-staging and M-staging in comparison to 18F FDG PET/CT To assess the value of Vasovist-enhanced MRI for T- and N-staging using histological tissue examination as reference and 18F FDG PET/CT as comparator (only patients with mediastinoscopy and/or surgical exploration) To assess the value of Vasovist®-enhanced MRI for prediction of postoperative lung function using the postoperative forced expiratory volume in the first second of expiration (FEV1) as reference and – if available – lung perfusion scintigraphy as comparator To assess the diagnostic value of Vasovist®-enhanced MRI for the assessment of operability (detection of lymph node and organ metastasis and estimation of postoperative lung function) in comparison to the combined assessment with 18F FDG PET/CT and lung perfusion scintigraphy To assess image quality and diagnostic confidence of Vasovist-enhanced MRI
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients with lung cancer considered for surgical resection 2. PET/CT with 18F-FDG performed for clinical reasons within 3 weeks before the planned MR examination 3. Age: between 18 and 85 years. 4. Patients who have personally provided written informed consent
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E.4 | Principal exclusion criteria |
1. Secondary cancer or history of cancer other than lung cancer 2. Patients presenting with a contraindication to MRI such as pacemaker, aneurysm clip, or severe claustrophobia 3. Patients being unable to tolerate a MRI examination of approximately 60 min (e.g. patients with dyspnea at rest, severe back pain) 4. History of severe allergic reaction or allergic reaction to MR contrast agents 5. Allergy to any of the ingredients of Vasovist 6. If female, pregnant or nursing 7. Patients with moderate or sever renal impairment (GFR below 60 mL/min/1.73 m2 calculated according to MDRD or Cockroft-Gault formula using a blood creatinine value determined within 4 weeks before Vasovist®-enhanced MRI) 8. Uncooperative, in the investigator’s opinion 9. Having been previously enrolled in this study 10. Participating in another clinical trial
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary target variable is the number of concordant classifications (agreement rate) between Vasovist®-enhanced MRI and 18F FDG PET/CT regarding the classification as N3 or non-N3 (i.e., N0, N1, or N2) as assessed in an independent blinded read. |
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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.6.13.1 | Other scope of the trial description |
Phase IIa, Diagnostic Exploratory |
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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 | Yes |
E.7.1.3.1 | Other trial type description |
Phase IIa, Diagnostic Exploratory |
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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 | 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.8.2.3.1 | Comparator description |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | |
E.8.9.1 | In the Member State concerned months | 15 |
E.8.9.1 | In the Member State concerned days | |