Benefits Study of Respiratory-gated PET Acquisition in Lung Disease

Lung Cancer Clinical Trial

— PneumoTEP  

Official title:

Benefits Study of a Respiratory Gating Protocol for Positron Emission Tomography: Application on the Lungs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01812031
• Other study ID #: AOL09-PR-MEYER
• Secondary ID: 2009-A00491-56
• Status: Completed
• Phase: N/A
• First received: March 13, 2013
• Last updated: February 26, 2015
• Start date: August 2009
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Centre Hospitalier Universitaire, Amiens
• 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: February 2015
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Chronic Obstructive Pulmonary Disease
• Lung Cancer
• Lung Diseases, Obstructive
• Lung Neoplasms
• Non Small Cell Lung Cancer
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• medical imaging
After fasting for at least 6 hours, normal glucose blood level was checked and each patient received an intravenous injection of 18F-FDG (5MBq/kg). After a 60-minute uptake phase in a quiet environment, patients underwent the PET/CT examination. Whole-body PET/CT (Ungated session) The Ungated acquisition consisted in a whole-body, free-breathing CT followed by standard multistep PET, used as routine clinical practice in the department. Respiratory-gated PET/CT (CT-based session) The CT-based method consisted in an additional single-step, 10-minute List Mode respiratory gated PET acquisition followed by an end-expiration breath-hold CT added to the end of the clinical protocol, with continuous respiratory signal recording during these examinations.

Locations

Country	Name	City	State
France	CHU Amiens	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

References & Publications (2)

Daouk J, Bailly P, Kamimura M, Sacksick D, Jounieaux V, Meyer ME. Positron emission tomography-based evidence of low-amplitude respiratory motion in patients with chronic obstructive pulmonary disease. Ann Nucl Med. 2015 May;29(4):319-24. doi: 10.1007/s12 — View Citation

Daouk J, Leloire M, Fin L, Bailly P, Morvan J, El Esper I, Saidi L, Moullart V, François G, Jounieaux V, Meyer ME. Respiratory-gated 18F-FDG PET imaging in lung cancer: effects on sensitivity and specificity. Acta Radiol. 2011 Jul 1;52(6):651-7. doi: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lesion SUVmax	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)	Day 1	No
Secondary	Lung function test	Patients undergo lung function test including measures of: total lung capacity; residual volume; forced expiratory volume; forced vital capacity	Day 0	No