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

Non-small Cell Lung Cancer Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00380666
• Other study ID #: 20060021
• Status: Withdrawn
• Phase: N/A
• Start date: June 2007
• Est. completion date: July 2010

Study information

• Verified date: May 2021
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• PET/CT scan

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	The Danish Medical Research Council

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance indices between CT-based and PET/CT-based target definitions versus volumes of surgical specimens		1 month
Secondary	Intra- and inter-individual variability of target definition		1 month