Early Changes in Positron Emissions Tomography (PET/CT) Scan as Predictors of Clinical Outcome in NSCLC Treated With EGFR Tyrosin Kinase Inhibitors (TKI)

Non-small Cell Lung Cancer Patients Clinical Trial

Official title:

Early Changes in 18F-fluorodeoxyglucose Positron Emissions Tomography (18F-FDG-PET/CT) Scan as Predictors of Clinical Outcome in NSCLC Treated With EGFR Tyrosin Kinase Inhibitors (TKI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043002
• Other study ID #: Thomas
• Status: Completed
• Phase: N/A
• First received: January 17, 2014
• Last updated: April 18, 2017
• Start date: April 2013
• Est. completion date: August 2015

Study information

• Verified date: January 2014
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Erlotinib, an anti-cancer agent targeting the epidermal growth factor receptor (EGFR), is an active treatment of patients with non-small cell lung cancer (NSCLC). Effect of treatment is primary seen in patients harboring a mutation in the EGFR. However, 10-15% of patients does not harbor a mutation but respond as well. Identifying these patients is a problem and methods are lacking.

Studies have shown that an early 18F FDG-PET might can predict response and outcome in these patients, but further studies are needed to confirm these findings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: August 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Lung Cancer patients with non-small cell histology and stage IV disease

• candidate for erlotinib treatment as first/ second/ third line of treatment

Exclusion Criteria:

• pregnancy

• severe dyspnoea

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer Patients

Intervention

Procedure:
• 18F-FDG-PET scan

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Jylland

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	18F-FDG-PET evaluation	Standardized Uptake Values (SUV) will be used as measurement of 18F-FDG uptake	Time to progression and latest april 2015 (up to 2 years)