PneumoTEP: Benefits Study of Respiratory-gated PET Acquisition in Lung Disease

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Completed

CT.gov ID

NCT01812031

Collaborator

(none)

103

Enrollment

Location

Arm

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Non Small Cell Lung Cancer Chronic Obstructive Pulmonary Disease	Other: medical imaging	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

103 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Single (Investigator)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Aug 1, 2009

Actual Primary Completion Date :

Feb 1, 2013

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lung nodules "Medical imaging" intervention applied on patients included in the trial	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. Other Names: Biograph Siemens medical solutions Anzai medical

Arm

Intervention/Treatment

Experimental: Lung nodules

"Medical imaging" intervention applied on patients included in the trial

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.

Other Names:

Biograph

Siemens medical solutions

Anzai medical

Outcome Measures

Primary Outcome Measures

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

Lung function test [Day 0]
Patients undergo lung function test including measures of: total lung capacity residual volume forced expiratory volume forced vital capacity

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens	Amiens	Picardie	France	80054

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

Principal Investigator: Marc-Etienne MEYER, MD, PhD, CHU Amiens

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire, Amiens

ClinicalTrials.gov Identifier:

NCT01812031

Other Study ID Numbers:

AOL09-PR-MEYER
2009-A00491-56

First Posted:

Mar 15, 2013

Last Update Posted:

Feb 27, 2015

Last Verified:

Feb 1, 2015

Keywords provided by Centre Hospitalier Universitaire, Amiens

PET/CT

18F-fluoro-2-deoxyglucose

lung neoplasms

respiratory motion

Additional relevant MeSH terms:

Lung Neoplasms

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Feb 27, 2015