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

Non-small Cell Lung Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02755675
• Other study ID #: AK-2015-LC-1
• Status: Recruiting
• Phase: Phase 2
• First received: April 19, 2016
• Last updated: November 18, 2016
• Start date: April 2016
• Est. completion date: October 2023

Study information

• Verified date: November 2016
• Source: Rigshospitalet, Denmark
• Contact: Malene M Clausen, MD, PhD
• Phone: +4522524536
• Email: malene.martini.clausen[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Neuroendocrine
• Carcinoma, Non-Small-Cell Lung
• Large Cell Neuroendocrine Carcinoma of the Lung
• Lung Neoplasms
• Malignant Pleural Mesothelioma
• Mesothelioma
• Non-small Cell Lung Cancer

Intervention

Other:
• 68Ga-NOTA-AE105 PET/CT
Following injection of 68Ga-NOTA-AE105 the patients will be subjected to PET/CT

Locations

Country	Name	City	State
Denmark	Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study Ia: Overall survival (OS)		Study Ia: OS is evaluated after clinical follow-up for 18 months (stage IV disease)	No
Primary	Study Ib: Overall survival (OS)		Study Ib: OS is evaluated after clinical follow-up for 60 months (operable disease)	No
Primary	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	No
Secondary	Study Ia: Progression free survival (PFS)		Study Ia: PFS is evaluated after clinical follow-up for 18 months (stage IV disease)	No
Secondary	Study Ib: Disease free survival (DFS)		Study Ib: DFS is evaluated after clinical follow-up for 60 months (operable disease)	No