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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01889212
• Other study ID #: 1-10-72-19-12
• Status: Terminated
• Phase: N/A
• First received: June 3, 2013
• Last updated: October 27, 2016
• Start date: April 2013
• Est. completion date: April 2015

Study information

• Verified date: June 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Other:
• 11C-erlotinib PET/CT

Locations

Country	Name	City	State
Denmark	Deparment of oncology, Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accumulation of 11c-erlotinib in tumors before and after treatment with erlotinib	Accumulation of 11c-erlotinib in tumors will be correlated to PFS on erlotinib treatment.	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	Yes

External Links

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