Lung; NodulePETGATQUANTNCT05779865
Study of Different Gating Techniques for PET Image of Lung and Liver Lesions
An observational study of Lung; Nodule and Liver Metastases, run by Centre Hospitalier Princesse Grace at 1 site in Monaco.
Trial summary
Lesions blurred by respiratory motion are common in fluorine-18 PET/CT studies. To avoid these artefacts, several standard gating correction technics are available. the investigator aimed to compare the impact of different gating techniques based on phase, amplitude, elastic-motion monitored with and without pressurre… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung; Nodule, Liver Metastases
- How many people
- 29 participants
- Where
- 1 siteMonaco
- Study dates
- 15 Feb 2023to 21 Sep 2023
- Phase
- Observational
- 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
Study population: Patients with lung or liver nodules
Who may be able to join
- presence at least of one hepatic or lung nodule
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Different Gating Techniques of Positron Emission Tomography Acquisition Focus on Lung or Liver Nodules. Comparaison on Phantoms and a Series of Patients
Lesions blurred by respiratory motion are common in fluorine-18 PET/CT studies. To avoid these artefacts, several standard gating correction technics are available. the investigator aimed to compare the impact of different gating techniques based on phase, amplitude, elastic-motion monitored with and without pressurre sensor device on standardized uptake value (SUVmax and SUVpeak) and uptake volume (UV) measurements on different sizes of pulmonary and liver lesions. The feasability of this study will be done using anthropomorphic coupled with a motion phantom and on a series of patients.
Read the detailed description
PET-CT images will be acquired on a Biograph Vision600 PET/CT, fitted with 26cm axial field of view and time of flight.
Phantom study will use an anthropomorphic TORSO phantom with a programmable motion phantom, mimicking respiratory motion (QUASAR). Spheres with various internal diameters will be introduce into the lungs (air density) adding an axial mechanical device simulating breathing movement of +/-20mm. Concentration in the spheres will be the same for all diameters. The background and liver activities will be approximatively respectively 38 and 14 MBq. This phantom will be a simulating patient only for lung lesions.
The investigator will compare 6 different PET acquisitions: standard 3min acquisition without movement as our reference of "trues SUVmax and UV", 3min acquisition with simulated breathing movement without any gating and 3min with respectively gating techniques based on phase, amplitude, elastic-motion monitored with and without pressurre sensor device.
Patient study will be on 50 consecutive patients with lung or liver nodules. 18F-FDG injection will be around 2.5 MBq/kg.
The investigator will compare 5 different PET acquisitions: standard acquisition with free respiratory movement as our reference of "trues SUVmax and UV", acquisitions with respectively gating techniques based on phase, amplitude, elastic-motion monitored with and without pressurre sensor device.
- Conditions
- Lung; Nodule, Liver Metastases
- Keywords
- positron emission tomography, nodule uptake, gating, quantification
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the different gating systems in lung lesions visualization
Classification, based on a phantom and patients studies, of the different gating system in view of the volume and SUV (max and peak) modification for lung lesions
Measured: Inclusion
Secondary outcomes (1)
Comparison of the different gating systems in liver lesions visualization
Classification, based on a patients studies, of the different gating system in view of the volume and SUV (max and peak) modification for liver lesions
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start15 Feb 2023
- Primary completion1 Jun 2023
- Study completion21 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung; NoduleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Princesse Grace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779865
- Sponsor's protocol ID
- 23-04
- Acronym
- PETGATQUANT
- Status last verified
- Sep 2023
- First submitted
- 9 Feb 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Meier JG, Wu CC, Betancourt Cuellar SL, Truong MT, Erasmus JR, Einstein S, Mawlawi O. Evaluation of a novel elastic respiratory motion correction algorithm on quantification and image quality in abdomino-thoracic PET/CT. J Nucl Med. 2018 Aug 16;60(2):279-284. doi: 10.2967/jnumed.118.213884. Online ahead of print.
PubMed 30115689Soret M, Bacharach SL, Buvat I. Partial-volume effect in PET tumor imaging. J Nucl Med. 2007 Jun;48(6):932-45. doi: 10.2967/jnumed.106.035774. Epub 2007 May 15.
PubMed 17504879
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Different Gating Techniques of Positron Emission Tomography Acquisition Focus on Lung or Liver Nodules. Comparaison on Phantoms and a Series of Patients
- ClinicalTrials.gov ID
- NCT05779865
- Acronym / sponsor ID
- PETGATQUANT / 23-04
- Conditions
- Lung; Nodule, Liver Metastases
- Keywords
- positron emission tomography, nodule uptake, gating, quantification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Centre Hospitalier Princesse GraceUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 22 Mar 2023 (actual)
- 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.
Lesions blurred by respiratory motion are common in fluorine-18 PET/CT studies. To avoid these artefacts, several standard gating correction technics are available. the investigator aimed to compare the impact of different gating techniques based on phase, amplitude, elastic-motion monitored with and without pressurre sensor device on standardized uptake value (SUVmax and SUVpeak) and uptake volume (UV) measurements on different sizes of pulmonary and liver lesions. The feasability of this study will be done using anthropomorphic coupled with a motion phantom and on a series of patients.
Detailed description
PET-CT images will be acquired on a Biograph Vision600 PET/CT, fitted with 26cm axial field of view and time of flight.
Phantom study will use an anthropomorphic TORSO phantom with a programmable motion phantom, mimicking respiratory motion (QUASAR). Spheres with various internal diameters will be introduce into the lungs (air density) adding an axial mechanical device simulating breathing movement of +/-20mm. Concentration in the spheres will be the same for all diameters. The background and liver activities will be approximatively respectively 38 and 14 MBq. This phantom will be a simulating patient only for lung lesions.
The investigator will compare 6 different PET acquisitions: standard 3min acquisition without movement as our reference of "trues SUVmax and UV", 3min acquisition with simulated breathing movement without any gating and 3min with respectively gating techniques based on phase, amplitude, elastic-motion monitored with and without pressurre sensor device.
Patient study will be on 50 consecutive patients with lung or liver nodules. 18F-FDG injection will be around 2.5 MBq/kg.
The investigator will compare 5 different PET acquisitions: standard acquisition with free respiratory movement as our reference of "trues SUVmax and UV", acquisitions with respectively gating techniques based on phase, amplitude, elastic-motion monitored with and without pressurre sensor device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lung or liver nodules
Key inclusion criteria (1 listed)
- presence at least of one hepatic or lung nodule
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of the different gating systems in lung lesions visualization
Time frame: Inclusion
Classification, based on a phantom and patients studies, of the different gating system in view of the volume and SUV (max and peak) modification for lung lesions
1 secondary outcome
Comparison of the different gating systems in liver lesions visualization
Time frame: Inclusion
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 25 Sep 2023.
- Background: PubMed 30115689Meier JG, Wu CC, Betancourt Cuellar SL, Truong MT, Erasmus JR, Einstein S, Mawlawi O. Evaluation of a novel elastic respiratory motion correction algorithm on quantification and image quality in abdomino-thoracic PET/CT. J Nucl Med. 2018 Aug 16;60(2):279-284. doi: 10.2967/jnumed.118.213884. Online ahead of print.
- Background: PubMed 17504879Soret M, Bacharach SL, Buvat I. Partial-volume effect in PET tumor imaging. J Nucl Med. 2007 Jun;48(6):932-45. doi: 10.2967/jnumed.106.035774. Epub 2007 May 15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung; Nodule and Liver Metastases, run by Centre Hospitalier Princesse Grace at 1 site in Monaco.
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 1 inclusion and 1 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 25 Sep 2023. 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 Monaco. 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?
Comparison of the different gating systems in lung lesions visualization (time frame: Inclusion). 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 NCT05779865, which also lists 2 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 25 Sep 2023.