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

April 18, 2017 updated by: University of Aarhus

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Jylland
      • Aarhus, Jylland, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 18F-FDG-PET scan
An early evaluation 18F-FDG-PET scan after 7-10 days
Procedure: 18F-FDG-PET scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time to progression and latest april 2015 (up to 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

January 17, 2014

First Submitted That Met QC Criteria

January 22, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Actual)

April 19, 2017

Last Update Submitted That Met QC Criteria

April 18, 2017

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Thomas

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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