Patients with primary diagnosis of non small cell lung cancer considered for surgical resection MedDRA version: 9.1 Level: LLT Classification code 10025044 Term: Lung cancer
Conditions
Sponsors
Universität Heidelberg, Medizinische Fakultät Mannheim
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the value of Vasovist-enhanced MRI for N-staging in lung cancer in comparison to 18F FDG PET/CT;Secondary Objective: 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 ;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. | — |
Countries
Germany
Outcome results
None listed