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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01421953
First received: August 11, 2011
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Lung Cancer
Non-small-cell Lung Carcinoma
Device: CT-simulation and 4D PET-CT

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
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)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421953

Contacts
Contact: Philippe FERNANDEZ, Pr philippe.fernandez@u-bordeaux2.fr
Contact: Sylvain LEDURE sylvain.ledure@chu-bordeaux.fr

Locations
France
CHU Bordeaux - hôpital Pellegrin Recruiting
Bordeaux, France, 33000
Contact: Sylvain LEDURE       sylvain.ledure@chu-bordeaux.fr   
Principal Investigator: Philippe FERNANDEZ, Pr         
Sub-Investigator: Henri DE CLERMONT, Dr         
Sub-Investigator: Bénédicte HENRIQUES DE FIGUEIREDO, Dr         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Philippe FERNANDEZ, Pr University Hospital, Bordeaux, France
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01421953     History of Changes
Other Study ID Numbers: CHUBX 2011/01
Study First Received: August 11, 2011
Last Updated: July 31, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Positron Emission Tomography
Computed Tomography
Lung cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014