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

Phase 2

• Conditions: Non-small Cell Lung Cancer; Malignant Pleural Mesothelioma; Large Cell Neuroendocrine Carcinoma of the Lung
• Interventions: Other: 68Ga-NOTA-AE105 PET/CT

• Registration Number: NCT02755675
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-28
• Study First Posted: 2016-04-29
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-18
• Last Update Posted: 2016-11-21
• Primary Completion: 2023-04
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-NOTA-AE105 PET/CT	68Ga-NOTA-AE105 PET/CT	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet; 🇩🇰 Copenhagen, Denmark