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The Utility of PET/CT in the Planning of Stereotactic Body Radiotherapy for Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00380666
Recruitment Status : Withdrawn (Technical problems.)
First Posted : September 26, 2006
Last Update Posted : July 12, 2010
Sponsor:
Collaborator:
The Danish Medical Research Council
Information provided by:
University of Aarhus

Brief Summary:
The trial evaluates the utility of 18FDG-PET/CT scan in the target definition process when SBRT is planned for stage I NSCLC.

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Procedure: PET/CT scan

Detailed Description:
The trial aims to evaluate the utility of 18FDG-PET/CT in SBRT planning for NSCLC with particular emphasis on the definition of macroscopic and microscopic boundaries of malignant growth. Studies indicate that the definition of the gross tumor volume may gain in quality when CT and 18FDG-PET are combined. In about 30-60% of NSCLC patients considered for radiotherapy, alteration of CT-based treatment volumes is the consequence of a supplementary 18FDG-PET scan. Studies examining the effect of combined PET/CT scans on the delineation of the GTV generally show reduced intra- and inter-clinician variability. Whether this higher degree of consistency is an actual improvement remains to be proven. Pathological specimens from operated NSCLC patients may serve as a gold standard in this respect. To meet the need for tight margins, the clinical target volume in SBRT planning is generally presumed to correspond to the GTV. Whether this clinical practice rests on firm ground is also an issue that can be addressed in a PET-CT-pathology correlation study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2007
Primary Completion Date : July 2010
Estimated Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Concordance indices between CT-based and PET/CT-based target definitions versus volumes of surgical specimens

Secondary Outcome Measures :
  1. Intra- and inter-individual variability of target definition


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or above
  • Histologically or cytologically verified NSCLC
  • Disease stage I (T1-2 N0 M0)
  • Referred from the multi-disciplinary lung cancer conference at Aarhus University Hospital for operation at Skejby Hospital, Aarhus University Hospital
  • Oral and written informed consent

Exclusion Criteria:

  • Medically treated diabetes mellitus
  • Fasting blood-glucoses above 6,7 mM
  • Blood-creatinin above normal
  • Allergies to intravenous contrast
  • Detention according to the Danish laws on psychiatrics that does not comply with participation in a clinical trial
  • Employment at the Dept. of Oncology, Aarhus University Hospital
  • Pregnancy
  • Lactation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00380666


Sponsors and Collaborators
University of Aarhus
The Danish Medical Research Council
Investigators
Principal Investigator: Morten Hoyer, MD, PhD Aarhus University Hospital

Responsible Party: Morten Høyer, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00380666     History of Changes
Other Study ID Numbers: 20060021
First Posted: September 26, 2006    Key Record Dates
Last Update Posted: July 12, 2010
Last Verified: July 2010

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms