uPAR-PET for Prognostication in Patients With Non-small Cell Lung Cancer, Malignant Pleural Mesothelioma and Large Cell Neuroendocrine Carcinoma of the Lung

Rigshospitalet

Status and phase: Unknown; Phase 2

Conditions: Malignant Pleural Mesothelioma; Large Cell Neuroendocrine Carcinoma of the Lung; Non-small Cell Lung Cancer

Treatments: Other: 68Ga-NOTA-AE105 PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT02755675

AK-2015-LC-1

Details and patient eligibility

About

uPAR PET/CT as a prognostic marker in non-small cell lung cancer.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 1 patient group

68Ga-NOTA-AE105 PET/CT

Experimental group

Description:

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.

Treatment:

Other: 68Ga-NOTA-AE105 PET/CT