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

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)

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Non-small-cell Lung Carcinoma
• Intervention / Treatment: Device: CT-simulation and 4D PET-CT

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • CHU Bordeaux - Hôpital Pellegrin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Dosimetrics differences between the dosimetries obtained from CT-simulation or from 4D-PET-CT.	between day 7 and day 21 after inclusion
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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Philippe FERNANDEZ, Pr, University Hospital, Bordeaux, France

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: August 11, 2011
• First Submitted That Met QC Criteria: August 22, 2011
• First Posted (Estimated): August 23, 2011

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Positron Emission Tomography; Lung cancer; Computed Tomography
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CHUBX 2011/01; 2011-A00299-32 (Other Identifier: ANSM)