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due to difficulties with recruiting
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| Name | Class |
|---|---|
| Norwegian University of Science and Technology | OTHER |
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The overall aim of this study is to compare standard staging of lung cancer (which includes clinical examination, CT, MRI, bone scan and PET-CT) with comprehensive staging - which includes the new staging methods (PET-MRI and systematic mapping of mediastinal and hilar lymph nodes using endobronchial ultrasound) with respect to disease stage and outcomes of therapy.
The trial is a randomized, explorative study. Patients undergoing examinations for suspicions of lung cancer (Stage I-III) are randomized to either standard diagnostic work-up for lung cancer (Arm A, n=75) or comprehensive diagnostic work-up (Arm B, n=75) with standard examinations plus endobronchial-screening for metastatic lymph nodes (EBUS-TBNA) and PET-MRI.
All patients will undergo todays' standard examination for diagnosing and staging lung cancer. This will be individualized for each patient according to current guidelines. In addition to the standard diagnostic work-up, patients in the interventional group (ArmB) will undergo
1) PET-MRI 2) systematic mediastinal and hilar lymph node mapping using EBUS-TBNA (endobronchial ultrasound transbronchial needle aspiration of lymph nodes)
After the initial diagnostic work-up is completed, the patient will be given treatment according to existing guidelines for lung cancer based on the given clinical stage.
For patients undergoing surgery all accessible lymph nodes will be resected according to standard practice. Every resected lymph node will be carefully named according to the standard lymph station for comparison with clinical findings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard diagnostic work-up | No Intervention | All patients will undergo todays' standard work-up (examination for diagnosing and staging) of lung cancer. This will be individualized for each patient according to current guidelines. | |
| Extensive diagnostic work-up | Experimental | All patients will in addition to standard diagnostic work-up undergo PET-MRI and systematic mediastinal and hilar lymph node mapping using EBUS-TBNA (endobronchial ultrasound transbronchial needle aspiration of lymph nodes). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET-MRI and EBUS-TBNA | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Progression free survival in one year |
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| Name | Affiliation | Role |
|---|---|---|
| Sveinung Sørhaug, MD PhD | St. Olavs Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St.Olavs Hospital, Trondheim University Hospital, Dept of Thoracic Medicine | Trondheim | 7006 | Norway |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |