Benefits Study of Respiratory-gated PET Acquisition in Lung Disease

NCT01812031 | Completed

• 2 other identifiers: AOL09-PR-MEYER2009-A00491-56
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Non Small Cell Lung Cancer; Chronic Obstructive Pulmonary Disease

Keywords

PET/CT; 18F-fluoro-2-deoxyglucose; lung neoplasms; respiratory motion

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Lung function test

  Day 0

Study Arms (1)

Lung nodules

EXPERIMENTAL

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

Other: medical imaging

Interventions

medical imaging OTHER

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.

Also known as: Biograph, Siemens medical solutions, Anzai medical

Lung nodules

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, Picardie, 80054, France

Location

Related Publications (3)

• Daouk J, Leloire M, Fin L, Bailly P, Morvan J, El Esper I, Saidi L, Moullart V, Francois 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: 10.1258/ar.2011.110018. Epub 2011 Apr 21.

  PMID: 21511870 RESULT

• 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/s12149-014-0945-3. Epub 2015 Jan 8.

  PMID: 25567204 RESULT

• Fin L, Daouk J, Morvan J, Bailly P, El Esper I, Saidi L, Meyer ME. Initial clinical results for breath-hold CT-based processing of respiratory-gated PET acquisitions. Eur J Nucl Med Mol Imaging. 2008 Nov;35(11):1971-80. doi: 10.1007/s00259-008-0858-2. Epub 2008 Jun 26.

  PMID: 18581114 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Pulmonary Disease, Chronic Obstructive

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Marc-Etienne MEYER, MD, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: March 15, 2013
• Study Start: August 1, 2009
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2015
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

FR (1)