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

NCT02755675 | Unknown Phase 2

• 1 other identifier: AK-2015-LC-1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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)

Study Arms (1)

68Ga-NOTA-AE105 PET/CT

EXPERIMENTAL

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

Interventions

68Ga-NOTA-AE105 PET/CT OTHER

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

68Ga-NOTA-AE105 PET/CT

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Study I, II, III
• Pregnancy
• Lactation/breast feeding
• Treatment with neoadjuvant chemotherapy
• Weight above 140 kg
• Allergy to 68Ga-NOTA-AE105

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Mesothelioma, Malignant

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Pleural Neoplasms

Central Study Contacts

Malene M Clausen, MD, PhD

CONTACT

+4522524536; malene.martini.clausen@regionh.dk

Andreas Kjaer, MD,DMSc,PhD

CONTACT

+4535454011; akjaer@sund.ku.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, postdoc

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 29, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 21, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)