- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01219985
Benefits Study of Respiratory-gated Positron Emission Tomography Acquisitions of the Liver (RespiTEP)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Picardy
-
Amiens, Picardy, France, 80054
- Centre Hospitalier Universitaire d'Amiens
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patient planed to undergo any liver surgical intervention
- age : over 18
- patients gave their written informed consent
Exclusion Criteria:
- pregnancy
- liver surgical intervention cancel upon surgical or medical decision
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Investigation arm
"standard and respiratory-gated PET acquisitions " for patients included in the trial.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lesions Uptake Measurement (SUVmax)
Time Frame: Day 1
|
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.
|
Day 1
|
Collaborators and Investigators
Investigators
- Study Director: Marc-Etienne Meyer, Pr, CHU Amiens
Publications and helpful links
General 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.
- Daouk 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 record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI07-PR-MEYER2
- 2007-A01343-50 (Other Identifier: RCB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Liver Cancer
-
Slawa CwajnaNova Scotia Health AuthorityWithdrawnPrimary Liver Cancer | Metastatic Liver CancerCanada
-
Duke UniversityCompletedPrimary Liver Cancer | Metastatic Liver Cancer From Any Cancer SiteUnited States
-
University of HawaiiGlaxoSmithKlineRecruitingAdvanced Adult Primary Liver Cancer | Localized Unresectable Adult Primary Liver Cancer | Adult Primary Liver CancerUnited States
-
Célia TurcoCompletedPrimary Liver Cancer | Liver Metastases | Secondary Liver CancerFrance
-
University of CincinnatiActive, not recruitingLiver Metastases | Advanced Adult Primary Liver Cancer | Localized Unresectable Adult Primary Liver Cancer | Recurrent Adult Primary Liver CancerUnited States
-
Lisa H. Butterfield, Ph.D.National Cancer Institute (NCI)TerminatedHepatocellular Carcinoma | Liver Cancer | Cancer of Liver | Hepatoma | Hepatocellular Cancer | Hepatic Cancer | Liver Cell Carcinoma | Cancer, Hepatocellular | Liver Cancer, Adult | Liver Cell Carcinoma, Adult | Cancer of the Liver | Neoplasms, Liver | Hepatic Neoplasms | Neoplasms, HepaticUnited States
-
Radboud University Medical CenterTerumo Medical CorporationCompletedPrimary Liver Cancer | Liver Cancer | Liver Metastasis Colon CancerNetherlands
-
Cardiovascular and Interventional Radiological...RecruitingPrimary Liver Cancer | Secondary Liver CancerGermany
-
Shanghai Huihe Medical Technology Co., LtdEnrolling by invitation
-
Burzynski Research InstituteTerminatedPrimary Liver CancerUnited States
Clinical Trials on standard and respiratory-gated PET acquisitions
-
Philips Electronics Nederland B.V. acting through...CompletedPregnancy RelatedFrance
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Metastatic Malignant Neoplasm in the Liver | Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Metastatic...United States
-
Acibadem UniversityCompletedHeart Diseases | Robotic Surgical ProceduresTurkey
-
Heidelberg UniversityFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico; Great Ormond Street... and other collaboratorsCompletedPrimary Study Outcome: Sodium Clearance in Dialysis | Solute Removal | UltrafiltrationGermany
-
Yale UniversityTerminatedBrain MetastasisUnited States
-
National Cancer Center, KoreaTerminatedPancreatic CancerKorea, Republic of
-
M.D. Anderson Cancer CenterCompletedEsophageal Cancer | Lung Cancer | Gastrointestinal DiseaseUnited States
-
Michael Bau MortensenOdense University HospitalUnknownStomach Cancer | Pancreatic Cancer | Esophageal CancerDenmark
-
Assistance Publique Hopitaux De MarseilleCompleted
-
Qifu LiWest China Hospital; Tongji Hospital; Second Affiliated Hospital, School of Medicine... and other collaboratorsRecruitingPrimary AldosteronismChina