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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PET/CT defined target

Target defined by use of fluoro-deoxy-glucose (FDG)-PET/CT scan for planning af stereotactic radiotherapy.

Group Type OTHER

PET/CT scan

Intervention Type PROCEDURE

Interventions

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PET/CT scan

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No