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Imaging With 11C-erlotinib PET/CT to Identify Responders to Erlotinib Treatment in NSCLC

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01889212
Recruitment Status : Terminated (Due to technical problems)
First Posted : June 28, 2013
Last Update Posted : October 28, 2016
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

New treatment strategies have been developed in lung cancer targeting the Epidermal Growth Factor Receptor (EGFR). Patients with an activating mutation in the EGFR have high responds rates to the treatment and should be treated with a EGFR inhibitor as first line of treatment. Some wild type patients do as well respond but selection of these patients is more difficult.

Erlotinib has been labeling with 11C and used as a new PET tracer. Accumulation of the tracer (11C-erlotinib) in tumors has showed promising results for selection of responders.

The investigators now want to conduct a larger clinical study to evaluate if accumulation of tracer on a pre-treatment 11C-erlotinib PET/CT can predict responds to erlotinib.


Condition or disease Intervention/treatment Phase
Lung Cancer Other: 11C-erlotinib PET/CT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Imaging With 11C-erlotinib PET/CT to Identify Responders to Erlotinib Treatment in NSCLC
Study Start Date : April 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NSCLC, erlotinib treatment, 11C-erlotinib PET/CT Other: 11C-erlotinib PET/CT



Primary Outcome Measures :
  1. Accumulation of 11c-erlotinib in tumors before and after treatment with erlotinib [ Time Frame: From date of inclusion until the date of first documented progression on the erlotinib treatment or date of death, whichever came first, assessed up to 30 months ]
    Accumulation of 11c-erlotinib in tumors will be correlated to PFS on erlotinib treatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Lung Cancer patients with non-small cell histology and stage IV disease who are candidate for erlotinib treatment as first/ second/ third line of treatment

Exclusion Criteria:

  • pregnancy
  • severe dyspnoea

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): NCT01889212


Locations
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Denmark
Deparment of oncology, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
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Principal Investigator: Peter Meldgaard, Ph.D MD Aarhus University Hospital
Additional Information:
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01889212    
Other Study ID Numbers: 1-10-72-19-12
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: June 2013
Additional relevant MeSH terms:
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Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action