Back to resultsPET Enhanced CT Scan Performance in Cancer (COMBITEP)
Primary Purpose
Cancer Disease Progression
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
COMBI TEP : PET / enhanced CT scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Cancer Disease Progression focused on measuring PET scan, CT scan, Diagnostic performance
Eligibility Criteria
Inclusion Criteria:
Any patient with a cancerous disease for which PET scan is indicated in the SOR (Standards - Options - Recommendations) FDG PET 2003 updated in 2006 must be included in the trial, in the following locations:
Digestive cancers
Colorectal cancer
- Preoperative evaluation in local and metastatic recurrence
- Location of recurrences, in case of ACE increase in a previously operated patient.
- Esophageal cancer: initial staging.
Pancreatic cancer
- Initial staging,
- Differential diagnosis with chronic pancreatitis.
- Liver cancer: differential diagnosis of liver metastases, cholangiocarcinoma and benign tumors in the case of an isolated hepatic localization.
- Digestive Endocrine tumors: staging in case of normal pentetreotide scintigraphy.
Lung cancer
- Initial staging,
- Diagnosis of lung isolated lesion > 1 cm.
Head and neck cancer
- Initial pretreatment staging,
- Recurrence diagnosis
Lymphoma
- Initial staging of Hodgkin's disease (HD), non-Hodgkin's lymphoma (NHL) and aggressive follicular lymphomas,
- Diagnosis of minimal residual disease of HD and aggressive NHL,
- Early assessment of treatment response.
- Thyroid cancer: suspicion of residual disease or relapse when conventional imaging data are insufficient.
- Ovarian cancer recurrence
- Age ≥ 18 years.
- Chest-abdomen-pelvis enhanced CT scan achieved within 4 weeks before enrollment (with cuts of less than 5 mm).
- Woman of childbearing age with negative pregnancy test and / or contraception.
- Patient with informed consent signed.
- Patient affiliated to social security schemes.
Exclusion Criteria:
- Iodine known allergy.
- Diabetes, excepted if controlled (hemoglucotest ≤ 1.6 g).
- Known renal failure (creatinine clearance <60ml/min).
Indications against Xenetix ®:
- Hypersensitivity to Xenetix ® or any of the excipients,
- History of an immediate response or delayed cutaneous reaction to Xenetix ® injection.
- Thyrotoxicosis.
- Pregnant or lactating women.
- Unable to undergo medical follow up for geographical, social or psychological reasons,
- Private of freedom patient and adult under a legal guardianship or unable to consent.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
COMBI TEP : PET / enhanced CT scan
Arm Description
COMBI TEP : PET / enhanced CT scan
Outcomes
Primary Outcome Measures
Inter-observer (B1 and B2) Reproducibility of the PET-CT by Anatomical Regions
The primary endpoint was the inter-observer reproducibility of the interpretation of the combined PET / enhanced CT scan (PET-CT) by anatomical region. Reproducibility was assessed for each of the 5 anatomical regions (thorax, abdomen, pelvis, bone, nervous system). Two independant pairs (B1 and B2), each composed of one nuclear physician and one radiologist interpreted the PET-CT examination and described each of the 5 anatomical régions according to 3 modalities (Presence of suspicious lesion(s); Presence of dubious lesion(s); Absence of suspicious and dubious lesion). The inter-observer reproducibility (inter-pairs of observers) was evaluated for each anatomical region by comparing the interpretations of the two pairs, using the weighted kappa concordance coefficient [ref = Fleiss J, Levin B, Cho Paik M. Statistical methods for rates and proportions. Third ed. 2003.].Interpretation by B1 after PET-CT examination (1 month after). Interpretation by B2 at the end of the study
Secondary Outcome Measures
Inter-observer (B1 and B2) Reproducibility of the PET-CT at a Patient Level
The inter-observer reproducibility of combined PET-CT interpretations has been assessed globally for each patient. Same pairs of observer (B1 and B2) than for the primary endpoint evaluation interpreted the PET-CT examination in a global way and concluded for each patient. A weighted Kappa coefficient has been calculated from an identical methodology to that described for the primary endpoint evaluation. Interpretation by B1 was performed at least 1 month and 1 week after PET-CT examination. Interpretation by B2 was performed at the end of the study
Inter-observer (N1 and B2) Reproducibility of the PET-CT by Anatomical Regions
For each of the 5 anatomical régions (thorax, abdomen, pelvis, bone, nervous system), we evaluated the reproducibility between the interpretations of the PET-CT by the nuclear physician alone (N1) and the independent pair (B2) composed by one nuclear physician and one radiologist . The nuclear physician alone (N1) and the independent pair (B2) interpreted the PET-CT examination independently and described each anatomical region.The inter-observer reproducibility has been evaluated for each anatomical region by comparing the interpretations of the nuclear physician alone and that one of independent pair of nuclear physician and radiologist, using the weighted kappa concordance coefficient [ref = Fleiss J, Levin B, Cho Paik M. Statistical methods for rates and proportions. Third ed. 2003.].Interpretation by nuclear physician alone (N1) was performed within 1 week of PET-CT examination. Interpretation by B2 was performed at the end of the study
Inter-observer (N1 and B2) Reproducibility of the PET-CT at a Patient Level
The inter-observer reproducibility of combined PET-CT interpretations has been assessed globally for each patient. The nuclear physician alone (N1) and the independent pair (B2) interpreted the PET-CT examination independently in a global way and concluded for each patient. The inter-observer reproducibility has been evaluated at patient level by comparing the interpretations of the nuclear physician alone and that one of independent pair of nuclear physician and radiologist, using the weighted kappa concordance coefficient [ref = Fleiss J, Levin B, Cho Paik M. Statistical methods for rates and proportions. Third ed. 2003.]. Interpretation by nuclear physician alone (N1) was performed within 1 week of PET-CT examination. Interpretation by B2 was performed at the end of the study
Intra-observer Reproducibility of Injected CT Scan by Anatomical Regions
For each anatomical region, the reproducibility of the injected CT scan was evaluated. The same radiologist evaluated the two injected CT scans (CT1 and CT2) and interpreted them (Presence of suspicious lesion(s) OR presence of dubious lesion(s) OR absence of suspicious and dubious lesion). Intra-observer reproducibility was analyzed by using the individual analysis by each radiologist. A weighted Kappa concordance coefficient was calculated per anatomical region using a methodology identical to that described for the evaluation of the proncipal endpoint. Interpretation of CT1 was performed befor inclusion. Interpretation of CT2 was performed at the end of the study.
Intra-observer Reproducibility of Injected CT Scanat a Patient Level
The reproducibility of the injected CT scan was evaluated globally for each patient. The same radiologist evaluated the two injected CT scans (CT1 and CT2) and interpreted them (Presence of suspicious lesion(s) OR presence of dubious lesion(s) OR absence of suspicious and dubious lesion). Intra-observer reproducibility was analyzed by using the individual analysis by each radiologist. A weighted Kappa concordance coefficient was calculated using a methodology identical to that described for the evaluation of the proncipal endpoint. Interpretation of CT1 was performed befor inclusion. Interpretation of CT2 was performed at the end of the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01881620
Brief Title
PET Enhanced CT Scan Performance in Cancer
Acronym
COMBITEP
Official Title
PET / Enhanced CT Scan Performance in Cancer (Positron Emission Tomography Combined With Computed Tomography or Vascular Contrast CT Scan). COMBI TEP Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 19, 2010 (Actual)
Primary Completion Date
July 19, 2012 (Actual)
Study Completion Date
July 15, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Bergonié
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hypothesis:
The investigators would like to demonstrate that diagnosis performance of PET/CT scan without and with contrast agent (COMBI TEP), are equivalent or better than those of PET/ non enhanced CT scan (PET scan) associated with an enhanced CT scan. This research project is a pilot study given the few available data concerning this imaging exam reproducibility.
This study is a prospective single center study.
Detailed Description
Hypothesis:
We would like to demonstrate that diagnosis performance of PET/CT scan without and with contrast agent (COMBI TEP), are equivalent or better than those of PET/ non enhanced CT scan (PET scan) associated with an enhanced CT scan. This research project is a pilot study given the few available data concerning this imaging exam reproducibility. This study allows us to assess the feasibility of such a large-scale study, but also to evaluate COMBI TEP performance. From these estimates, we can then consider a comparative study to evaluate the performance of COMBI PET.
This study is a prospective single center study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Disease Progression
Keywords
PET scan, CT scan, Diagnostic performance
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COMBI TEP : PET / enhanced CT scan
Arm Type
Experimental
Arm Description
COMBI TEP : PET / enhanced CT scan
Intervention Type
Device
Intervention Name(s)
COMBI TEP : PET / enhanced CT scan
Other Intervention Name(s)
diagnostic imaging exam
Intervention Description
diagnostic imaging exam
Primary Outcome Measure Information:
Title
Inter-observer (B1 and B2) Reproducibility of the PET-CT by Anatomical Regions
Description
The primary endpoint was the inter-observer reproducibility of the interpretation of the combined PET / enhanced CT scan (PET-CT) by anatomical region. Reproducibility was assessed for each of the 5 anatomical regions (thorax, abdomen, pelvis, bone, nervous system). Two independant pairs (B1 and B2), each composed of one nuclear physician and one radiologist interpreted the PET-CT examination and described each of the 5 anatomical régions according to 3 modalities (Presence of suspicious lesion(s); Presence of dubious lesion(s); Absence of suspicious and dubious lesion). The inter-observer reproducibility (inter-pairs of observers) was evaluated for each anatomical region by comparing the interpretations of the two pairs, using the weighted kappa concordance coefficient [ref = Fleiss J, Levin B, Cho Paik M. Statistical methods for rates and proportions. Third ed. 2003.].Interpretation by B1 after PET-CT examination (1 month after). Interpretation by B2 at the end of the study
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Inter-observer (B1 and B2) Reproducibility of the PET-CT at a Patient Level
Description
The inter-observer reproducibility of combined PET-CT interpretations has been assessed globally for each patient. Same pairs of observer (B1 and B2) than for the primary endpoint evaluation interpreted the PET-CT examination in a global way and concluded for each patient. A weighted Kappa coefficient has been calculated from an identical methodology to that described for the primary endpoint evaluation. Interpretation by B1 was performed at least 1 month and 1 week after PET-CT examination. Interpretation by B2 was performed at the end of the study
Time Frame
1 year
Title
Inter-observer (N1 and B2) Reproducibility of the PET-CT by Anatomical Regions
Description
For each of the 5 anatomical régions (thorax, abdomen, pelvis, bone, nervous system), we evaluated the reproducibility between the interpretations of the PET-CT by the nuclear physician alone (N1) and the independent pair (B2) composed by one nuclear physician and one radiologist . The nuclear physician alone (N1) and the independent pair (B2) interpreted the PET-CT examination independently and described each anatomical region.The inter-observer reproducibility has been evaluated for each anatomical region by comparing the interpretations of the nuclear physician alone and that one of independent pair of nuclear physician and radiologist, using the weighted kappa concordance coefficient [ref = Fleiss J, Levin B, Cho Paik M. Statistical methods for rates and proportions. Third ed. 2003.].Interpretation by nuclear physician alone (N1) was performed within 1 week of PET-CT examination. Interpretation by B2 was performed at the end of the study
Time Frame
1 year
Title
Inter-observer (N1 and B2) Reproducibility of the PET-CT at a Patient Level
Description
The inter-observer reproducibility of combined PET-CT interpretations has been assessed globally for each patient. The nuclear physician alone (N1) and the independent pair (B2) interpreted the PET-CT examination independently in a global way and concluded for each patient. The inter-observer reproducibility has been evaluated at patient level by comparing the interpretations of the nuclear physician alone and that one of independent pair of nuclear physician and radiologist, using the weighted kappa concordance coefficient [ref = Fleiss J, Levin B, Cho Paik M. Statistical methods for rates and proportions. Third ed. 2003.]. Interpretation by nuclear physician alone (N1) was performed within 1 week of PET-CT examination. Interpretation by B2 was performed at the end of the study
Time Frame
1 year
Title
Intra-observer Reproducibility of Injected CT Scan by Anatomical Regions
Description
For each anatomical region, the reproducibility of the injected CT scan was evaluated. The same radiologist evaluated the two injected CT scans (CT1 and CT2) and interpreted them (Presence of suspicious lesion(s) OR presence of dubious lesion(s) OR absence of suspicious and dubious lesion). Intra-observer reproducibility was analyzed by using the individual analysis by each radiologist. A weighted Kappa concordance coefficient was calculated per anatomical region using a methodology identical to that described for the evaluation of the proncipal endpoint. Interpretation of CT1 was performed befor inclusion. Interpretation of CT2 was performed at the end of the study.
Time Frame
1 year
Title
Intra-observer Reproducibility of Injected CT Scanat a Patient Level
Description
The reproducibility of the injected CT scan was evaluated globally for each patient. The same radiologist evaluated the two injected CT scans (CT1 and CT2) and interpreted them (Presence of suspicious lesion(s) OR presence of dubious lesion(s) OR absence of suspicious and dubious lesion). Intra-observer reproducibility was analyzed by using the individual analysis by each radiologist. A weighted Kappa concordance coefficient was calculated using a methodology identical to that described for the evaluation of the proncipal endpoint. Interpretation of CT1 was performed befor inclusion. Interpretation of CT2 was performed at the end of the study.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any patient with a cancerous disease for which PET scan is indicated in the SOR (Standards - Options - Recommendations) FDG PET 2003 updated in 2006 must be included in the trial, in the following locations:
Digestive cancers
Colorectal cancer
Preoperative evaluation in local and metastatic recurrence
Location of recurrences, in case of ACE increase in a previously operated patient.
Esophageal cancer: initial staging.
Pancreatic cancer
Initial staging,
Differential diagnosis with chronic pancreatitis.
Liver cancer: differential diagnosis of liver metastases, cholangiocarcinoma and benign tumors in the case of an isolated hepatic localization.
Digestive Endocrine tumors: staging in case of normal pentetreotide scintigraphy.
Lung cancer
Initial staging,
Diagnosis of lung isolated lesion > 1 cm.
Head and neck cancer
Initial pretreatment staging,
Recurrence diagnosis
Lymphoma
Initial staging of Hodgkin's disease (HD), non-Hodgkin's lymphoma (NHL) and aggressive follicular lymphomas,
Diagnosis of minimal residual disease of HD and aggressive NHL,
Early assessment of treatment response.
Thyroid cancer: suspicion of residual disease or relapse when conventional imaging data are insufficient.
Ovarian cancer recurrence
Age ≥ 18 years.
Chest-abdomen-pelvis enhanced CT scan achieved within 4 weeks before enrollment (with cuts of less than 5 mm).
Woman of childbearing age with negative pregnancy test and / or contraception.
Patient with informed consent signed.
Patient affiliated to social security schemes.
Exclusion Criteria:
Iodine known allergy.
Diabetes, excepted if controlled (hemoglucotest ≤ 1.6 g).
Known renal failure (creatinine clearance <60ml/min).
Indications against Xenetix ®:
Hypersensitivity to Xenetix ® or any of the excipients,
History of an immediate response or delayed cutaneous reaction to Xenetix ® injection.
Thyrotoxicosis.
Pregnant or lactating women.
Unable to undergo medical follow up for geographical, social or psychological reasons,
Private of freedom patient and adult under a legal guardianship or unable to consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CAZEAU Anne Laure, MD
Organizational Affiliation
Institut Bergonié
Official's Role
Study Chair
12. IPD Sharing Statement
Links:
URL
https://www.bergonie.fr/les-essais-cliniques/
Description
Site internet du promoteur, l'Institut Bergonié
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PET Enhanced CT Scan Performance in Cancer
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