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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
120
Following injection of 68Ga-NOTA-AE105 the patients will be subjected to PET/CT
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Copenhagen, Denmark
RECRUITINGStudy Ia: Overall survival (OS)
Time frame: Study Ia: OS is evaluated after clinical follow-up for 18 months (stage IV disease)
Study Ib: Overall survival (OS)
Time frame: 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 +/-)
Time frame: 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
Study Ia: Progression free survival (PFS)
Time frame: Study Ia: PFS is evaluated after clinical follow-up for 18 months (stage IV disease)
Study Ib: Disease free survival (DFS)
Time frame: Study Ib: DFS is evaluated after clinical follow-up for 60 months (operable disease)
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