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N/A
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

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Trial Information


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Concordance indices between CT-based and PET/CT-based target definitions versus volumes of surgical specimens

Principal Investigator

Morten Hoyer, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Aarhus University Hospital

Authority:

Denmark: The Danish National Committee on Biomedical Research Ethics

Study ID:

20060021

NCT ID:

NCT00380666

Start Date:

June 2007

Completion Date:

July 2010

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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