Large Cell Neuroendocrine Carcinoma of the Lung, Malignant Pleural Mesothelioma, Non-small Cell Lung Cancer
Conditions
Brief summary
uPAR PET/CT as a prognostic marker in non-small cell lung cancer.
Detailed description
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.
Interventions
Following injection of 68Ga-NOTA-AE105 the patients will be subjected to PET/CT
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Study I * Histologically verified NSCLC (Study I) * Stage IV disease * Operable disease * The participants must be capable of understanding and giving full informed written consent Study II * Histologically verified MPM (Study II) * The participants must be capable of understanding and giving full informed written consent Study III * Histologically verified LCNEC (Study III) * The participants must be capable of understanding and giving full informed written consent
Exclusion criteria
Study I, II, III * Pregnancy * Lactation/breast feeding * Treatment with neoadjuvant chemotherapy * Weight above 140 kg * Allergy to 68Ga-NOTA-AE105
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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) |
Countries
Denmark
Contacts
Primary ContactMalene M Clausen, MD, PhD
Backup ContactAndreas Kjaer, MD,DMSc,PhD
Outcome results
None listed