Assessment of 4D 18F-FDG PET-CT in Radiotherapy for Non Small Cell Lung Cancers (PULMOTEP)
Primary Purpose
Lung Cancer, Non-small-cell Lung Carcinoma
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CT-simulation and 4D PET-CT
Sponsored by
About this trial
This is an interventional supportive care trial for Lung Cancer focused on measuring Positron Emission Tomography, Computed Tomography, Lung cancer
Eligibility Criteria
Inclusion Criteria:
- age ≥ 18 years old
- patients with unresectable non small cell lung cancer having to be treated with radiotherapy or radio-chemotherapy
Exclusion Criteria:
- neo-adjuvant treatment
- patient treated previously with thoracic radiation
- patient unable to support 4D PET-CT
- pregnant or breast-feeding woman
Sites / Locations
- CHU Bordeaux - hôpital Pellegrin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients
Arm Description
Outcomes
Primary Outcome Measures
Quantitative and qualitative differences between CT-simulation and 4D PET-CT volumes
Quantitative and qualitative differences between the radiotherapy target volumes obtained from CT-simulation and from 4D-PET-CT.
The quantitative difference is expressed as a percentage of the total volume defined on CT simulation.
The qualitative difference is defined as the volumes defined only on CT-simulation or only on 4D-PET-CT, expressed as a percentage of the total volume defined on CT-simulation.
Secondary Outcome Measures
Dosimetrics differences between the dosimetries obtained from CT-simulation or from 4D-PET-CT.
Search of predictive criteria (histology, tumour localization, TNM staging) for 4D-PET-CT impact on the radiotherapy target volumes and on the dosimetries.
Full Information
NCT ID
NCT01421953
First Posted
August 11, 2011
Last Updated
October 22, 2014
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT01421953
Brief Title
Assessment of 4D 18F-FDG PET-CT in Radiotherapy for Non Small Cell Lung Cancers
Acronym
PULMOTEP
Official Title
Assessment of Four-dimensional (4D) 18F-fluoro-deoxy-glucose (FDG) Positron Emission Tomography and Computed Tomography System (PET-CT) in Radiotherapy for Non Small Cell Lung Cancers (NSCLC)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Computed tomography (CT) images, used for radiotherapy planning, are often caught out in lung target volumes delineation because of their inability to differentiate between neoplasia, inflammation and atelectasia. Positron Emission Tomography (PET) is a new functional imaging modality and is currently used in the diagnosis and the staging of lung cancers. The aim of this study is to evaluate the impact of 4D 18F-FDG-PET-CT on radiotherapy planning for lung cancers.
Detailed Description
Many PET studies have been interested in lung radiotherapy volumes definition, however lacking any standardisation. Effectively, the use of PET images is difficult because of the poor image quality resulting from noise and partial volume effects induced blurring. Moreover, due to the long duration of PET acquisitions, respiratory motions are inevitable and result in artifacts in the PET images affecting the volumes and contrast of the tumour: tumours may appear larger while their activity can be lower. To overcome these limitations, we propose to use a 4D PET-CT, ie a PET-CT acquisition system synchronized with respiration in order to compare CT-simulation target volumes and PET target volumes after application of different approaches for partial volume effect correction, respiratory motion correction and automatic segmentation method of functional volumes. For this purpose, patients with a non small cell lung cancer and having to be treated with radiotherapy or radio-chemotherapy underwent CT-simulation and 4D PET-CT in radiotherapy treatment position. The target volumes and the dosimetries obtained with both modalities were compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Non-small-cell Lung Carcinoma
Keywords
Positron Emission Tomography, Computed Tomography, Lung cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CT-simulation and 4D PET-CT
Intervention Description
Patients will do a CT-simulation and 4D PET-CT in radiotherapy treatment position. The target volumes and the dosimetries obtained with both modalities will be compared.
Primary Outcome Measure Information:
Title
Quantitative and qualitative differences between CT-simulation and 4D PET-CT volumes
Description
Quantitative and qualitative differences between the radiotherapy target volumes obtained from CT-simulation and from 4D-PET-CT.
The quantitative difference is expressed as a percentage of the total volume defined on CT simulation.
The qualitative difference is defined as the volumes defined only on CT-simulation or only on 4D-PET-CT, expressed as a percentage of the total volume defined on CT-simulation.
Time Frame
between day 7 and day 21 after inclusion
Secondary Outcome Measure Information:
Title
Dosimetrics differences between the dosimetries obtained from CT-simulation or from 4D-PET-CT.
Time Frame
between day 7 and day 21 after inclusion
Title
Search of predictive criteria (histology, tumour localization, TNM staging) for 4D-PET-CT impact on the radiotherapy target volumes and on the dosimetries.
Time Frame
between day 7 and day 21 after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age ≥ 18 years old
patients with unresectable non small cell lung cancer having to be treated with radiotherapy or radio-chemotherapy
Exclusion Criteria:
neo-adjuvant treatment
patient treated previously with thoracic radiation
patient unable to support 4D PET-CT
pregnant or breast-feeding woman
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe FERNANDEZ, Pr
Organizational Affiliation
University Hospital, Bordeaux, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Bordeaux - hôpital Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Assessment of 4D 18F-FDG PET-CT in Radiotherapy for Non Small Cell Lung Cancers
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