Assessment of 4D 18F-FDG PET-CT in Radiotherapy for Non Small Cell Lung Cancers

Lung Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01421953
• Other study ID #: CHUBX 2011/01
• Status: Completed
• Phase: N/A
• First received: August 11, 2011
• Last updated: October 22, 2014
• Start date: August 2011
• Est. completion date: November 2012

Study information

• Verified date: October 2014
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
France	CHU Bordeaux - hôpital Pellegrin	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	between day 7 and day 21 after inclusion	No
Secondary	Dosimetrics differences between the dosimetries obtained from CT-simulation or from 4D-PET-CT.		between day 7 and day 21 after inclusion	No
Secondary	Search of predictive criteria (histology, tumour localization, TNM staging) for 4D-PET-CT impact on the radiotherapy target volumes and on the dosimetries.		between day 7 and day 21 after inclusion	No