Benefits Study of Respiratory-gated PET Acquisition in Lung Disease

NCT ID: NCT01812031

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2015-02-28

Brief Summary

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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

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Conditions

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Lung Cancer Non Small Cell Lung Cancer Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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Lung nodules

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

Group Type EXPERIMENTAL

medical imaging

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Biograph Siemens medical solutions Anzai medical

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc-Etienne MEYER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

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CHU Amiens

Amiens, Picardie, France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 21511870 (View on PubMed)

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.

Reference Type RESULT
PMID: 25567204 (View on PubMed)

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.

Reference Type RESULT
PMID: 18581114 (View on PubMed)

Other Identifiers

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2009-A00491-56

Identifier Type: REGISTRY

Identifier Source: secondary_id

AOL09-PR-MEYER

Identifier Type: -

Identifier Source: org_study_id

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