A Phase 2 interventional study of 68Ga-NOTA-AE105 PET/CT in Non-small Cell Lung Cancer, Malignant Pleural Mesothelioma and Large Cell Neuroendocrine Carcinoma of the Lung, sponsored by Rigshospitalet, Denmark. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-11-21.
Sponsored by Rigshospitalet, Denmark · Phase 2 and Interventional
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 120 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
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Study I
Study II
Study III
Exclusion Criteria:
Study I, II, III
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.
Other: 68Ga-NOTA-AE105 PET/CT
Following injection of 68Ga-NOTA-AE105 the patients will be subjected to PET/CT
Study 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)
Plan to share: No
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This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Rigshospitalet, Denmark