Benefits Study of Respiratory-gated PET Acquisition in Lung Disease

Not Applicable

Completed

• Conditions: Lung Cancer; Non Small Cell Lung Cancer; Chronic Obstructive Pulmonary Disease
• Interventions: Other: medical imaging

• Registration Number: NCT01812031
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

Fluorodeoxyglucose (FDG) positron emission tomography (PET) is now widely used for cancer imaging purpose, notably for preoperative work-up. It aims at visualizing organs metabolism. In case of cancer, metabolism is, classically, increased and some hot spots are visible on PET images. Because of respiratory motion some lung tumours (especially the smallest ones) can be falsely interpreted by the clinician.

The investigators developed a respiratory-gated PET method in order to reduce the motion issue. The investigators designed a study to investigate its effect on lung cancer (primary or metastasis) to check if it improves the sensitivity/specificity of PET imaging of the lungs.

To that aim, patients presenting a lung nodule on a CT examination can be proposed to participate this study. After the standard PET acquisition (acquired in free-breathing), an additional 10 minutes respiratory-gated PET acquisition is performed without additional injection. After that, a breath-hold (\~10s) CT is performed.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2013-02
• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-03-13
• Study First Posted: 2013-03-15
• Status Verified: 2015-02
• Study Completion: 2015-02
• Last Update Submitted: 2015-02-26
• Last Update Posted: 2015-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• patient has one or more lung lesion(s) less than 35 mm visible on a CT image
• age : over 18 years
• patients gave their written informed consent

Exclusion Criteria

• pregnancy
• patient has at least one lesion more than 35 mm in its great axis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lung nodules	medical imaging	"Medical imaging" intervention applied on patients included in the trial

Primary Outcome Measures

Name	Time	Method
Lesion SUVmax	Day 1	For each CT nodule, observer has to report the corresponding (maximum Standardized Uptake Value)SUVmax on ungated and CT-based images (even if there is no obvious uptake)

Secondary Outcome Measures

Name	Time	Method
Lung function test	Day 0	Patients undergo lung function test including measures of: * total lung capacity; * residual volume; * forced expiratory volume; * forced vital capacity

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, Picardie, France