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

This study has been withdrawn prior to enrollment.
(Technical problems.)
Sponsor:
Collaborator:
The Danish Medical Research Council
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00380666
First received: September 25, 2006
Last updated: July 9, 2010
Last verified: July 2010
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

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

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

Estimated Enrollment: 30
Study Start Date: June 2007
Estimated Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00380666

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

No publications provided

Responsible Party: Morten Høyer, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00380666     History of Changes
Other Study ID Numbers: 20060021
Study First Received: September 25, 2006
Last Updated: July 9, 2010
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

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

ClinicalTrials.gov processed this record on September 18, 2014