Non Small Cell Lung CancerSPI COHERENCENCT01720186
Evaluation of a Pneumotachograph (SPI) for the Production of PET and CT Acquisitions Synchronized With Breath for the Assessment of Extension of Lung Cancer
A study testing PET/CT 4D imaging in a synchronized mode centered on the thorax. in people with Non Small Cell Lung Cancer and Lung Nodule, run by Institut Claudius Regaud at 1 site in France.
Trial summary
This is a pilot study, single-center, prospective, open-label, to assess the acceptability and performance of the experimental medical device (SPI) used during an imaging examination (PET / CT 4D imaging in synchronized mode centered on the thorax). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Lung Nodule
- What is being tested?
- PET/CT 4D imaging in a synchronized mode centered on the thorax.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Sep 2014
- 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 for whom there is an indication of PET/CT 18FDG imaging for thoracic oncology ; this indication is consistent with the Standard Options Recommendations or was validated during Multidisciplinary Consultation Meeting :
- Either an extension assessment of non-small cell lung cancer;
- Either the characterization of single pulmonary nodule; Or - the definition of the target volume in radiotherapy.
- Patient who meets the following criteria to be eligible for an PET/CT imaging:
- Patient able to maintain a supine position for 60 minutes
- Patient with no bronchopulmonary infection and with no upper aero digestive tract acute infection in progress (increased risk of false positives)
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- Age ≥ 18 years
- WHO ≤ 1
- Well-informed written consent signed by the patient and collected before any specific procedure in the study
- Patient member in a national insurance scheme
Who cannot join
- Patient with a bronchial carcinoid or bronchoalveolar cancer
- Patient with acute bronchopneumopathy
- Not stabilized diabetic patient
- Patient with an absolute indication against spirometry: ongoing pneumothorax or within the previous month, pleural biopsy or puncture within the previous month, hemoptysis, severe asthma, tuberculosis
- Any usual relative indication against spirometry: ongoing bronchial infections, acute asthma, decompensation of chronic respiratory failure, respiratory pain
- Any usual formal indication against imaging examination PET/CT (important claustrophobia)
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- Patient unable to follow study procedures
- Pregnant women or nursing mothers can not participate in the study
- Men and women of childbearing age must use effective contraception at study entry and throughout the study
- Any other medical conditions making the inclusion of the patient in the study inappropriate in the opinion of the investigator
- Patient under legal guardianship
Trial locations and contacts
1 site in 1 country.
About this study
This is a pilot study, single-center, prospective, open-label, to assess the acceptability and performance of the experimental medical device (SPI) used during an imaging examination (PET / CT 4D imaging in synchronized mode centered on the thorax). Each patient will be its own control, since the imaging examination will be synchronized simultaneously with the two systems: tested Medical Device (SPI) and reference Medical Device(RPM).
- Conditions
- Non Small Cell Lung Cancer, Lung Nodule
- Being tested
- PET/CT 4D imaging in a synchronized mode centered on the thorax.
- Keywords
- Lung Cancer, PET/CT, FDG, Respiratory synchronization
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT 4D imaging in a synchronized mode centered on the thorax.Device
| Study group | Role | What they receive |
|---|---|---|
| SPI Medical device | Experimental | SPI medical device used during PET/CT 4D imaging in a synchronized mode centered on the thorax. Receives: Device: PET/CT 4D imaging in a synchronized mode centered on the thorax. |
| reference medical device : RPM | Active comparator | Reference medical device (RPM) used simultaneously during PET/CT 4D imaging in a synchronized mode centered on the thorax. Receives: Device: PET/CT 4D imaging in a synchronized mode centered on the thorax. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the PET/CT synchronized exam with SPI device ("success" or "failure" )
feasibility is evaluated in a composite end point (success will be obtained in case of concomitant success of the 4 sub-criteria assessment):
- Tolerance / acceptability of the patient to breathe into SPI throughout the examination)
- Detection of breath cycle of the patient by measuring dCycleSpi (dCycleSpi = Number of synchronization signals emitted by SPI / total number of breath cycle * 100).
- Accuracy of detection of inspiratory peak amplitudes with SPI medical device: by measuring dtSpi (dtSpi = standard deviation of the time lag between synchronization signals and maximum inspiratory amplitude for each cycle).
- Production of images with a correct segmentation of BTV during PET/CT synchronized exam with SPI device"
Measured: 2 years
Secondary outcomes (3)
Measure of dCycleRpm (dCycleRpmi = Number of synchronization signals emitted by RPM / total number of breath cycle * 100)
Measured: 2 years
Accuracy of detection of maximum inspiratory amplitudes with RPM medical device: evaluated by measuring dtRpm
dtRpm = standard deviation of the time lag between synchronization signals and maximum inspiratory amplitude for each cycle
Measured: 2 years
Measure of BTVrpm (= biologic tumoral volume)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startMay 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic COURBON, PhD, Principal investigator, Institut Claudius Regaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720186
- Sponsor's protocol ID
- 12POUM01
- Acronym
- SPI COHERENCE
- Status last verified
- Sep 2026
- First submitted
- 12 Oct 2012
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Jaudet C, Filleron T, Weyts K, Didierlaurent D, Vallot D, Ouali M, Zerdoud S, Dierickx OL, Caselles O, Courbon F. Gated 18F-FDG PET/CT of the Lung Using a Respiratory Spirometric Gating Device: A Feasibility Study. J Nucl Med Technol. 2019 Sep;47(3):227-232. doi: 10.2967/jnmt.118.223339. Epub 2019 Apr 24.
PubMed 31019044
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Pneumotachograph (SPI) for the Production of PET and CT Acquisitions Synchronized With Breath for the Assessment of Extension of Lung Cancer
- ClinicalTrials.gov ID
- NCT01720186
- Acronym / sponsor ID
- SPI COHERENCE / 12POUM01
- Conditions
- Non Small Cell Lung Cancer, Lung Nodule
- Keywords
- Lung Cancer, PET/CT, FDG, Respiratory synchronization
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 2 Nov 2012 (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.
This is a pilot study, single-center, prospective, open-label, to assess the acceptability and performance of the experimental medical device (SPI) used during an imaging examination (PET / CT 4D imaging in synchronized mode centered on the thorax). Each patient will be its own control, since the imaging examination will be synchronized simultaneously with the two systems: tested Medical Device (SPI) and reference Medical Device(RPM).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPI Medical device | Experimental | Device: PET/CT 4D imaging in a synchronized mode centered on the thorax.SPI medical device used during PET/CT 4D imaging in a synchronized mode centered on the thorax. |
| reference medical device : RPM | Active comparator | Device: PET/CT 4D imaging in a synchronized mode centered on the thorax.Reference medical device (RPM) used simultaneously during PET/CT 4D imaging in a synchronized mode centered on the thorax. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient for whom there is an indication of PET/CT 18FDG imaging for thoracic oncology ; this indication is consistent with the Standard Options Recommendations or was validated during Multidisciplinary Consultation Meeting :
- Patient who meets the following criteria to be eligible for an PET/CT imaging:
- Age ≥ 18 years
- WHO ≤ 1
- Well-informed written consent signed by the patient and collected before any specific procedure in the study
Key exclusion criteria (11 listed)
- Patient with a bronchial carcinoid or bronchoalveolar cancer
- Patient with acute bronchopneumopathy
- Not stabilized diabetic patient
- Patient with an absolute indication against spirometry: ongoing pneumothorax or within the previous month, pleural biopsy or puncture within the previous month, hemoptysis, severe asthma, tuberculosis
- Any usual relative indication against spirometry: ongoing bronchial infections, acute asthma, decompensation of chronic respiratory failure, respiratory pain
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 |
|---|---|---|
| PET/CT 4D imaging in a synchronized mode centered on the thorax. | Device | SPI Medical device, reference medical device : RPM |
Primary outcome
Feasibility of the PET/CT synchronized exam with SPI device ("success" or "failure" )
Time frame: 2 years
feasibility is evaluated in a composite end point (success will be obtained in case of concomitant success of the 4 sub-criteria assessment): 1. Tolerance / acceptability of the patient to breathe into SPI throughout the examination) 2. Detection of breath cycle of the patient by measuring dCycleSpi (dCycleSpi = Number of synchronization signals emitted by SPI / total number of breath cycle * 100). 3. Accuracy of detection of inspiratory peak amplitudes with SPI medical device: by measuring dtSpi (dtSpi = standard deviation of the time lag between synchronization signals and maximum inspiratory amplitude for each cycle). 4. Production of images with a correct segmentation of BTV during PET/CT synchronized exam with SPI device"
3 secondary outcomes
Measure of dCycleRpm (dCycleRpmi = Number of synchronization signals emitted by RPM / total number of breath cycle * 100)
Time frame: 2 years
Accuracy of detection of maximum inspiratory amplitudes with RPM medical device: evaluated by measuring dtRpm
Time frame: 2 years
Measure of BTVrpm (= biologic tumoral volume)
Time frame: 2 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Results publication: PubMed 31019044Jaudet C, Filleron T, Weyts K, Didierlaurent D, Vallot D, Ouali M, Zerdoud S, Dierickx OL, Caselles O, Courbon F. Gated 18F-FDG PET/CT of the Lung Using a Respiratory Spirometric Gating Device: A Feasibility Study. J Nucl Med Technol. 2019 Sep;47(3):227-232. doi: 10.2967/jnmt.118.223339. Epub 2019 Apr 24.
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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.
Frederic COURBON, PhD principal investigator
Institut Claudius Regaud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/CT 4D imaging in a synchronized mode centered on the thorax. in people with Non Small Cell Lung Cancer and Lung Nodule, run by Institut Claudius Regaud 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 10 inclusion and 11 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: stopped early, as of the sponsor's last update on 18 Sep 2026. 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 was stopped early. Results are not available in the source record.
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?
Feasibility of the PET/CT synchronized exam with SPI device ("success" or "failure" ) (time frame: 2 years). 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 NCT01720186, which also lists 1 linked publication.
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 18 Sep 2026.