Liver CancerRespiTEPNCT01219985
Benefits Study of Respiratory-gated Positron Emission Tomography Acquisitions of the Liver
A study testing standard and respiratory-gated PET acquisitions in people with Liver 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
- Liver Cancer
- What is being tested?
- standard and respiratory-gated PET acquisitions
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2008to Jun 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 planed to undergo any liver surgical intervention
- age : over 18
- patients gave their written informed consent
Who cannot join
- pregnancy
- liver surgical intervention cancel upon surgical or medical decision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefits Study of a Respiratory Gating Protocol for 18F-FDG PET: Application on the Liver
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 and because the liver is intrinsically FDG avid, some tumours (especially the smallest ones) can be occulted and missed by the clinician.
The investigators developed a respiratory-gated PET method in order to reduce the motion issue. This protocol has been validated on lung pathologies. The investigators designed a study to investigate its effect on liver cancer (primary or metastasis) to check if it allows the detection of a higher number of tumour lesions.
To that aim, patients who are planned to undergo a surgical intervention on the liver 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.
Read the detailed description
Introduction:
18-fluoro-2-deoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) became a major imaging modality for management of patients with suspected hepatic cancer notably because of its ability to detect distant metastases. Hepatic resection is known to be the only curative treatment in a subset of patients suffering liver neoplasm. Eligibility for hepatic surgery lays on conventional staging comprising contrast-enhanced CT, magnetic resonance imaging or ultrasonography of the liver. Recently, 18F-FGD PET/CT has been introduced as a staging modality in the preoperative work up.
However, many physiological issues could affect PET interpretation. Indeed, some lesions could be missed by the physician due to histology of the lesion (e.g. in case of moderate or well-differentiated hepatocellular carcinoma (HCC) or mucinous carcinoma). Unlike, local inflammations could be wrongly considered as malignant.
Another issue for liver examination with PET imaging is the respiratory motion as it produces blurring in reconstructed images. Therefore, some lesions may be missed or underestimated. This motion issue is well known for thoracic imaging and various methods were proposed to deal with it. We have developed a respiratory motion compensation method where gated PET events are selected on the base of a breath-hold CT (CT-based).
To our knowledge, no sensitivity study was performed to assess the usefulness of gated acquisitions in term of lesions detection at abdominal stage. W In this trial, we apply our gating method on the liver to compare lesion-per-lesion sensitivity of clinical (Ungated) and CT-based PET images.
PET/CT acquisitions:
All acquisitions (Ungated and CT-based) are performed on a whole-body PET/CT system.
- Whole-body PET/CT (Ungated session) The Ungated acquisition consists in a whole-body, free-breathing CT (110 kV; 85 mAs; pitch: 1) followed by standard multistep PET (3 minutes per step), as used in routine clinical practice in the department.
- Respiratory-gated PET/CT (CT-based session) The CT-based method consists in an additional single-step, 10-minute List Mode respiratory gated PET acquisition followed by an end-expiration breath-hold CT (110 kV; 50 mAs; pitch: 2) added to the end of the clinical protocol, with continuous respiratory signal recording during these examinations.
To summarize respiratory-gated PET processing, the breath-hold CT sequence is visible on the respiratory signal as a plateau. A selection range is placed around this plateau to select only the PET events which correspond to the same position as that of tissues at the time of breath-hold CT.
Image Reconstruction:
After compensation for random coincidences, all 3-dimensional (3D) sinograms are FORE-rebinned into two dimensions and scatter-corrected. The attenuation coefficients at 511 keV are calculated from the CT acquisition, in order to correct for tissue self-attenuation. Ungated volumes are corrected with the free-breathing whole-body CT scan and CT-based volumes are corrected with the end-expiration breath-hold CT. All PET volumes are reconstructed using AWOSEM with the following parameters: 4 iterations, 8 ordered subsets in 168 x 168 x 81 matrices (4.06 mm x 4.06 mm x 2 mm). Finally, a 3D isotropic Gaussian post filter with a full width at half maximum of 5 mm was applied.
Image analysis:
Each PET examination is blindly and independently analysed by experienced nuclear medicine physicians, i.e. neither the type of image nor the patients' information are known. Each clinician has to report the number of lesions detected in both Ungated and CT-based PET datasets. Should it be the case, for each lesion, they are asked to precise its location according to the Couinaud segmental classification and its maximum standardized uptake value (SUVmax).
Surgical procedure and histopathological analysis:
During surgery, intraoperative ultrasound are performed in order to detect and localize all liver lesions. Surgery is aimed at obtaining disease-free resection margins. The type of liver resection (hepatectomy or wedge(s)) is at the surgeon discretion as well as the use of radiofrequency tumour ablation. When available, surgical specimen are analysed in the department of histopathological analysis of our institution to determine the type of cancer and the location of the resected lesions.
- Conditions
- Liver Cancer
- Being tested
- standard and respiratory-gated PET acquisitions
- Keywords
- positron emission tomography / computed tomography, 18F-fluoro-2-deoxyglucose, liver neoplasm, respiratory motion
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard and respiratory-gated PET acquisitionsOther
Also called Biograph™, Siemens medical solutions, Anzai medical, Cisbio
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 |
|---|---|---|
| Investigation arm | Experimental | "standard and respiratory-gated PET acquisitions " for patients included in the trial. Receives: Other: standard and respiratory-gated PET acquisitions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Detected Uptakes on PET Images
Observers have to analyse Ungated and/or CT-based PET images. They have to report, for each uptake they see, the corresponding liver segment (according to Couinaud segmental classification).
Measured: day 1
Secondary outcomes (1)
Lesions Uptake Measurement (SUVmax)
For each detected uptake (in Ungated or CT-based PET images), observers have to report the corresponding maximum standardized uptake value (SUVmax). The SUVmax was obtained automatically in a volume of interest encompassing the entire lesion.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startApr 2008
- Primary completionDec 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver 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
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc-Etienne Meyer, Pr, Study director, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219985
- Sponsor's protocol ID
- PI07-PR-MEYER2
- Other IDs
- 2007-A01343-50
- Acronym
- RespiTEP
- Status last verified
- Apr 2016
- First submitted
- 12 Oct 2010
- Last updated
- 27 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Fin L, Daouk J, Bailly P, Slama J, Morvan J, El Esper I, Regimbeau JM, Chatelain D, Diouf M, Meyer ME. Improved imaging of intrahepatic colorectal metastases with 18F-fluorodeoxyglucose respiratory-gated positron emission tomography. Nucl Med Commun. 2012 Jun;33(6):656-62. doi: 10.1097/MNM.0b013e328351fce8.
PubMed 22382308Daouk J, Fin L, Bailly P, Slama J, Diouf M, Morvan J, El Esper I, Regimbeau J-M, Chatelain D, Meyer M-E. The Benefits of Respiratory Gating in 18F-FDG PET Imaging of the Liver, The International Journal of Nuclear Energy Science and Engineering 2(1):5-10, 2012
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits Study of a Respiratory Gating Protocol for 18F-FDG PET: Application on the Liver
- ClinicalTrials.gov ID
- NCT01219985
- Acronym / sponsor ID
- RespiTEP / PI07-PR-MEYER2
- Conditions
- Liver Cancer
- Keywords
- positron emission tomography / computed tomography, 18F-fluoro-2-deoxyglucose, liver neoplasm, respiratory motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Posted 10 Oct 2013
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 and because the liver is intrinsically FDG avid, some tumours (especially the smallest ones) can be occulted and missed by the clinician.
The investigators developed a respiratory-gated PET method in order to reduce the motion issue. This protocol has been validated on lung pathologies. The investigators designed a study to investigate its effect on liver cancer (primary or metastasis) to check if it allows the detection of a higher number of tumour lesions.
To that aim, patients who are planned to undergo a surgical intervention on the liver 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
Introduction:
18-fluoro-2-deoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) became a major imaging modality for management of patients with suspected hepatic cancer notably because of its ability to detect distant metastases. Hepatic resection is known to be the only curative treatment in a subset of patients suffering liver neoplasm. Eligibility for hepatic surgery lays on conventional staging comprising contrast-enhanced CT, magnetic resonance imaging or ultrasonography of the liver. Recently, 18F-FGD PET/CT has been introduced as a staging modality in the preoperative work up.
However, many physiological issues could affect PET interpretation. Indeed, some lesions could be missed by the physician due to histology of the lesion (e.g. in case of moderate or well-differentiated hepatocellular carcinoma (HCC) or mucinous carcinoma). Unlike, local inflammations could be wrongly considered as malignant.
Another issue for liver examination with PET imaging is the respiratory motion as it produces blurring in reconstructed images. Therefore, some lesions may be missed or underestimated. This motion issue is well known for thoracic imaging and various methods were proposed to deal with it. We have developed a respiratory motion compensation method where gated PET events are selected on the base of a breath-hold CT (CT-based).
To our knowledge, no sensitivity study was performed to assess the usefulness of gated acquisitions in term of lesions detection at abdominal stage. W In this trial, we apply our gating method on the liver to compare lesion-per-lesion sensitivity of clinical (Ungated) and CT-based PET images.
PET/CT acquisitions:
All acquisitions (Ungated and CT-based) are performed on a whole-body PET/CT system.
- Whole-body PET/CT (Ungated session) The Ungated acquisition consists in a whole-body, free-breathing CT (110 kV; 85 mAs; pitch: 1) followed by standard multistep PET (3 minutes per step), as used in routine clinical practice in the department.
- Respiratory-gated PET/CT (CT-based session) The CT-based method consists in an additional single-step, 10-minute List Mode respiratory gated PET acquisition followed by an end-expiration breath-hold CT (110 kV; 50 mAs; pitch: 2) added to the end of the clinical protocol, with continuous respiratory signal recording during these examinations.
To summarize respiratory-gated PET processing, the breath-hold CT sequence is visible on the respiratory signal as a plateau. A selection range is placed around this plateau to select only the PET events which correspond to the same position as that of tissues at the time of breath-hold CT.
Image Reconstruction:
After compensation for random coincidences, all 3-dimensional (3D) sinograms are FORE-rebinned into two dimensions and scatter-corrected. The attenuation coefficients at 511 keV are calculated from the CT acquisition, in order to correct for tissue self-attenuation. Ungated volumes are corrected with the free-breathing whole-body CT scan and CT-based volumes are corrected with the end-expiration breath-hold CT. All PET volumes are reconstructed using AWOSEM with the following parameters: 4 iterations, 8 ordered subsets in 168 x 168 x 81 matrices (4.06 mm x 4.06 mm x 2 mm). Finally, a 3D isotropic Gaussian post filter with a full width at half maximum of 5 mm was applied.
Image analysis:
Each PET examination is blindly and independently analysed by experienced nuclear medicine physicians, i.e. neither the type of image nor the patients' information are known. Each clinician has to report the number of lesions detected in both Ungated and CT-based PET datasets. Should it be the case, for each lesion, they are asked to precise its location according to the Couinaud segmental classification and its maximum standardized uptake value (SUVmax).
Surgical procedure and histopathological analysis:
During surgery, intraoperative ultrasound are performed in order to detect and localize all liver lesions. Surgery is aimed at obtaining disease-free resection margins. The type of liver resection (hepatectomy or wedge(s)) is at the surgeon discretion as well as the use of radiofrequency tumour ablation. When available, surgical specimen are analysed in the department of histopathological analysis of our institution to determine the type of cancer and the location of the resected lesions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigation arm | Experimental | Other: standard and respiratory-gated PET acquisitions"standard and respiratory-gated PET acquisitions " for 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 planed to undergo any liver surgical intervention
- age : over 18
- patients gave their written informed consent
Key exclusion criteria (2 listed)
- pregnancy
- liver surgical intervention cancel upon surgical or medical decision
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 |
|---|---|---|
| standard and respiratory-gated PET acquisitionsAlso: Biograph™, Siemens medical solutions, Anzai medical, CisbioAfter 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 | Investigation arm |
Primary outcome
Number of Detected Uptakes on PET Images
Time frame: day 1
Observers have to analyse Ungated and/or CT-based PET images. They have to report, for each uptake they see, the corresponding liver segment (according to Couinaud segmental classification).
1 secondary outcome
Lesions Uptake Measurement (SUVmax)
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22382308Fin L, Daouk J, Bailly P, Slama J, Morvan J, El Esper I, Regimbeau JM, Chatelain D, Diouf M, Meyer ME. Improved imaging of intrahepatic colorectal metastases with 18F-fluorodeoxyglucose respiratory-gated positron emission tomography. Nucl Med Commun. 2012 Jun;33(6):656-62. doi: 10.1097/MNM.0b013e328351fce8.
- Results publicationDaouk J, Fin L, Bailly P, Slama J, Diouf M, Morvan J, El Esper I, Regimbeau J-M, Chatelain D, Meyer M-E. The Benefits of Respiratory Gating in 18F-FDG PET Imaging of the Liver, The International Journal of Nuclear Energy Science and Engineering 2(1):5-10, 2012
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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, Pr study director
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 standard and respiratory-gated PET acquisitions in people with Liver 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 27 May 2016. 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?
Yes. Results are posted in the registry (first posted 10 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Detected Uptakes on PET Images (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 NCT01219985, 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 27 May 2016.