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

NCT ID: NCT02043002

Last Updated: 2017-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-08-31

Brief 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.

Conditions

Non-small Cell Lung Cancer Patients

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

18F-FDG-PET scan

An early evaluation 18F-FDG-PET scan after 7-10 days

Group Type: EXPERIMENTAL

18F-FDG-PET scan

Intervention Type: PROCEDURE

Interventions

18F-FDG-PET scan

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Aarhus University Hospital

Aarhus, Jylland, Denmark

Countries

Denmark

Other Identifiers

Thomas

Identifier Type: -

Identifier Source: org_study_id