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

November 18, 2016 updated by: Malene Martini Clausen, Rigshospitalet, Denmark
uPAR PET/CT as a prognostic marker in non-small cell lung cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Andreas Kjaer, MD,DMSc,PhD
  • Phone Number: +4535454011
  • Email: akjaer@sund.ku.dk

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
        • Contact:
        • Contact:
          • Andreas Kjaer, Professor, MD, DMSc, PhD
          • Phone Number: +4535454011
          • Email: akjaer@sund.ku.dk
        • Principal Investigator:
          • Malene M Clausen, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 68Ga-NOTA-AE105 PET/CT
Following injection of 68Ga-NOTA-AE105 the patients will be subjected to PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Study Ia: Overall survival (OS)
Time Frame: Study Ia: OS is evaluated after clinical follow-up for 18 months (stage IV disease)
Study Ia: OS is evaluated after clinical follow-up for 18 months (stage IV disease)
Study Ib: Overall survival (OS)
Time Frame: Study Ib: OS is evaluated after clinical follow-up for 60 months (operable disease)
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 +/-)
Time Frame: 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
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

Outcome Measure
Time Frame
Study Ia: Progression free survival (PFS)
Time Frame: Study Ia: PFS is evaluated after clinical follow-up for 18 months (stage IV disease)
Study Ia: PFS is evaluated after clinical follow-up for 18 months (stage IV disease)
Study Ib: Disease free survival (DFS)
Time Frame: Study Ib: DFS is evaluated after clinical follow-up for 60 months (operable disease)
Study Ib: DFS is evaluated after clinical follow-up for 60 months (operable disease)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

April 19, 2016

First Submitted That Met QC Criteria

April 28, 2016

First Posted (Estimate)

April 29, 2016

Study Record Updates

Last Update Posted (Estimate)

November 21, 2016

Last Update Submitted That Met QC Criteria

November 18, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK-2015-LC-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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