The Utility of PET/CT in the Planning of Stereotactic Body Radiotherapy for Non-small Cell Lung Cancer
Primary Purpose
Non-small Cell Lung Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PET/CT scan
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
PET/CT defined target
Arm Description
Target defined by use of fluoro-deoxy-glucose (FDG)-PET/CT scan for planning af stereotactic radiotherapy.
Outcomes
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
Full Information
NCT ID
NCT00380666
First Posted
September 25, 2006
Last Updated
May 4, 2021
Sponsor
University of Aarhus
Collaborators
The Danish Medical Research Council
1. Study Identification
Unique Protocol Identification Number
NCT00380666
Brief Title
The Utility of PET/CT in the Planning of Stereotactic Body Radiotherapy for Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Technical problems.
Study Start Date
June 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
Collaborators
The Danish Medical Research Council
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PET/CT defined target
Arm Type
Other
Arm Description
Target defined by use of fluoro-deoxy-glucose (FDG)-PET/CT scan for planning af stereotactic radiotherapy.
Intervention Type
Procedure
Intervention Name(s)
PET/CT scan
Primary Outcome Measure Information:
Title
Concordance indices between CT-based and PET/CT-based target definitions versus volumes of surgical specimens
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Intra- and inter-individual variability of target definition
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morten Hoyer, MD, PhD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Utility of PET/CT in the Planning of Stereotactic Body Radiotherapy for Non-small Cell Lung Cancer
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