Completed

NCT Number: NCT02043002

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, Jylland, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18F-FDG-PET scan

Procedure

Primary outcomes

18F-FDG-PET evaluation

Time frame: Time to progression and latest april 2015 (up to 2 years)

Standardized Uptake Values (SUV) will be used as measurement of 18F-FDG uptake

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study 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)

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Jan 23, 2014
Registry last updated: Apr 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.