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

NCT01421953 | Completed

• 2 other identifiers: CHUBX 2011/012011-A00299-32
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Non-small-cell Lung Carcinoma

Keywords

Positron Emission Tomography; Computed Tomography; Lung cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Patients

EXPERIMENTAL

Device: CT-simulation and 4D PET-CT

Interventions

CT-simulation and 4D PET-CT DEVICE

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.

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years old
• patients with unresectable non small cell lung cancer having to be treated with radiotherapy or radio-chemotherapy

You may not qualify if:

• neo-adjuvant treatment
• patient treated previously with thoracic radiation
• patient unable to support 4D PET-CT
• pregnant or breast-feeding woman

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU Bordeaux - hôpital Pellegrin

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Philippe FERNANDEZ, Pr

  University Hospital, Bordeaux, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: August 23, 2011
• Study Start: August 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: May 29, 2026

Record last verified: 2014-10

Locations

FR (1)