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uPAR PET/CT as a prognostic marker in non-small cell lung cancer.
Study I: uPAR PET/CT with 68Ga-NOTA-AE105 will be evaluated as a prognostic tool in patients with non-small cell lung cancer (NSCLC) (stage IV (Ia) operable disease (Ib)) by observer-blinded readings and compared to the prognostic performance of FDG PET/CT and prognostic biomarkers as uPAR.
Furthermore, uPAR PET/CT will be evaluated in a pilot study in patients with malignant pleural mesothelioma (MPM) (Study II) and large cell neuroendocrine carcinoma of the lung (LCNEC) (Study III) and correlated with immunohistochemical uPAR expression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-NOTA-AE105 PET/CT | Experimental | One injection of 68Ga-NOTA-AE105 followed by positron emission tomography/computed tomography (PET/CT scan) will be performed before treatment start to evaluate the prognostic value of uPAR PET/CT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-NOTA-AE105 PET/CT | Other | Following injection of 68Ga-NOTA-AE105 the patients will be subjected to PET/CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Study Ia: Overall survival (OS) | Study Ia: OS is evaluated after clinical follow-up for 18 months (stage IV disease) | |
| Study Ib: Overall survival (OS) | Study Ib: OS is evaluated after clinical follow-up for 60 months (operable disease) | |
| Study II and III: Uptake of 68Ga-NOTA-AE105 in primary tumor lesion (dichotomized +/-) | Study II and III: Uptake of 68Ga-NOTA-AE105 is evaluated based on PET/CT scans performed within 1 hour post injection of 68Ga-NOTA-AE105 |
| Measure | Description | Time Frame |
|---|---|---|
| Study Ia: Progression free survival (PFS) | Study Ia: PFS is evaluated after clinical follow-up for 18 months (stage IV disease) | |
| Study Ib: Disease free survival (DFS) | Study Ib: DFS is evaluated after clinical follow-up for 60 months (operable disease) |
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Inclusion Criteria:
Study I
Study II
Study III
Exclusion Criteria:
Study I, II, III
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Malene M Clausen, MD, PhD | Contact | +4522524536 | malene.martini.clausen@regionh.dk | |
| Andreas Kjaer, MD,DMSc,PhD | Contact | +4535454011 | akjaer@sund.ku.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000086002 | Mesothelioma, Malignant |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018301 | Neoplasms, Mesothelial |
| D010997 | Pleural Neoplasms |
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