Assessment of 4D 18F-FDG PET-CT in Radiotherapy for Non Small Cell Lung Cancers (PULMOTEP)
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.
Non-small-cell Lung Carcinoma
Device: CT-simulation and 4D PET-CT
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|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)|
- Quantitative and qualitative differences between CT-simulation and 4D PET-CT volumes [ Time Frame: between day 7 and day 21 after inclusion ] [ Designated as safety issue: No ]
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.
- Dosimetrics differences between the dosimetries obtained from CT-simulation or from 4D-PET-CT. [ Time Frame: between day 7 and day 21 after inclusion ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Device: CT-simulation and 4D PET-CT
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421953
|Contact: Philippe FERNANDEZ, Prfirstname.lastname@example.org|
|Contact: Sylvain LEDUREemail@example.com|
|CHU Bordeaux - hôpital Pellegrin||Recruiting|
|Bordeaux, France, 33000|
|Contact: Sylvain LEDURE firstname.lastname@example.org|
|Principal Investigator: Philippe FERNANDEZ, Pr|
|Sub-Investigator: Henri DE CLERMONT, Dr|
|Sub-Investigator: Bénédicte HENRIQUES DE FIGUEIREDO, Dr|
|Principal Investigator:||Philippe FERNANDEZ, Pr||University Hospital, Bordeaux, France|