Lung CancerPneumoTEPNCT01812031
Benefits Study of Respiratory-gated PET Acquisition in Lung Disease
A study testing medical imaging in people with Lung Cancer and Non Small Cell Lung Cancer, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non Small Cell Lung Cancer, Chronic Obstructive Pulmonary Disease
- What is being tested?
- medical imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2009to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnancy
- patient has at least one lesion more than 35 mm in its great axis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefits Study of a Respiratory Gating Protocol for Positron Emission Tomography: Application on the Lungs
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.
- Being tested
- medical imaging
- Keywords
- PET/CT, 18F-fluoro-2-deoxyglucose, lung neoplasms, respiratory motion
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical imagingOther
Also called Biograph, Siemens medical solutions, Anzai medical
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.
| Study group | Role | What they receive |
|---|---|---|
| Lung nodules | Experimental | "Medical imaging" intervention applied on patients included in the trial Receives: Other: medical imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 1
Secondary outcomes (1)
Lung function test
Patients undergo lung function test including measures of:
- total lung capacity
- residual volume
- forced expiratory volume
- forced vital capacity
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2013 (estimated)
- Study startAug 2009
- Primary completionFeb 2013
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc-Etienne MEYER, MD, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812031
- Sponsor's protocol ID
- AOL09-PR-MEYER
- Other IDs
- 2009-A00491-56
- Acronym
- PneumoTEP
- Status last verified
- Sep 2025
- First submitted
- 13 Mar 2013
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21511870Daouk 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.
PubMed 25567204Fin 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.
PubMed 18581114
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits Study of a Respiratory Gating Protocol for Positron Emission Tomography: Application on the Lungs
- ClinicalTrials.gov ID
- NCT01812031
- Acronym / sponsor ID
- PneumoTEP / AOL09-PR-MEYER
- Keywords
- PET/CT, 18F-fluoro-2-deoxyglucose, lung neoplasms, respiratory motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 15 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung nodules | Experimental | Other: medical imaging"Medical imaging" intervention applied on patients included in the trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- pregnancy
- patient has at least one lesion more than 35 mm in its great axis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical imagingAlso: Biograph, Siemens medical solutions, Anzai medicalAfter 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 | Lung nodules |
Primary outcome
Lesion SUVmax
Time frame: 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)
1 secondary outcome
Lung function test
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Results publication: PubMed 21511870Daouk 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.
- Results publication: PubMed 25567204Daouk 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.
- Results publication: PubMed 18581114Fin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc-Etienne MEYER, MD, PhD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medical imaging in people with Lung Cancer and Non Small Cell Lung Cancer, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion SUVmax (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01812031, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.