Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02755675
Recruitment Status : Recruiting
First Posted : April 29, 2016
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
Malene Martini Clausen, Rigshospitalet, Denmark

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

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Malignant Pleural Mesothelioma Large Cell Neuroendocrine Carcinoma of the Lung Other: 68Ga-NOTA-AE105 PET/CT Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : April 2016
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : October 2023


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




Primary Outcome Measures :
  1. Study Ia: Overall survival (OS) [ Time Frame: Study Ia: OS is evaluated after clinical follow-up for 18 months (stage IV disease) ]
  2. Study Ib: Overall survival (OS) [ Time Frame: Study Ib: OS is evaluated after clinical follow-up for 60 months (operable disease) ]
  3. 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 ]

Secondary Outcome Measures :
  1. Study Ia: Progression free survival (PFS) [ Time Frame: Study Ia: PFS is evaluated after clinical follow-up for 18 months (stage IV disease) ]
  2. Study Ib: Disease free survival (DFS) [ Time Frame: Study Ib: DFS is evaluated after clinical follow-up for 60 months (operable disease) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02755675


Contacts
Layout table for location contacts
Contact: Malene M Clausen, MD, PhD +4522524536 malene.martini.clausen@regionh.dk
Contact: Andreas Kjaer, MD,DMSc,PhD +4535454011 akjaer@sund.ku.dk

Locations
Layout table for location information
Denmark
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Malene M Clausen, MD, PhD    +4522524536    malene.martini.clausen@regionh.dk   
Contact: Andreas Kjaer, Professor, MD, DMSc, PhD    +4535454011    akjaer@sund.ku.dk   
Principal Investigator: Malene M Clausen, MD, PhD         
Sponsors and Collaborators
Rigshospitalet, Denmark
Layout table for additonal information
Responsible Party: Malene Martini Clausen, MD, PhD, postdoc, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02755675    
Other Study ID Numbers: AK-2015-LC-1
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Mesothelioma
Carcinoma, Neuroendocrine
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Adenoma
Neoplasms, Mesothelial
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue