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

Not Applicable

Terminated

• Conditions: Lung Cancer
• Interventions: Other: 11C-erlotinib PET/CT

• Registration Number: NCT01889212
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-04
• Status Verified: 2013-06
• Study First Submitted: 2013-06-03
• Study First Submitted QC: 2013-06-25
• Study First Posted: 2013-06-28
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

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Exclusion Criteria

• pregnancy
• severe dyspnoea

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NSCLC, erlotinib treatment, 11C-erlotinib PET/CT	11C-erlotinib PET/CT	-

Primary Outcome Measures

Name	Time	Method
Accumulation of 11c-erlotinib in tumors before and after treatment with erlotinib	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.

Trial Locations

Locations (1)

Deparment of oncology, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark