18 Fluoro-deoxy-glucose Positrons Emission Tomography Combined With Computed Tomography (18-FDG TEP-CT ) in the Diagnosis of the Degeneration of Intraductal Papillary Mucinous Tumor of the Pancreas
Evaluation of 18 Fluoro-deoxy-glucose Positrons Emission Tomography Combined With Computed Tomography (18-FDG TEP-CT ) in the Diagnosis of the Degeneration of Intraductal Papillary Mucinous Tumor of the Pancreas
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Amiens, France, 80080
- CHU Nord
-
Bordeaux, France, 33604
- Maison de Haut Lévêque CHU
-
Clichy, France, 92110
- Hôpital Beaujon APHP
-
Lille, France, 59037
- Hôpital C Huriez
-
Lyon, France, 69437
- Hospices Civils de Lyon
-
Marseille, France, 13915
- CHU Nord
-
Marseille, France, 13273
- Institut Paoli Calmettes
-
Nantes, France, 44093
- CHU
-
Paris, France, 75012
- Hôpital St-Antoine
-
Rennes, France, 35033
- CHU Hôpital Pontchaillou
-
Strasbourg, France, 67098
- Hôpital de Hautepierre
-
Toulouse, France, 31059
- CHU Rangueil
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults with age equal or above 18
- Patients diagnosed with intraductal papillary mucinous tumor with surgical indication and for whom it will be possible to have the pathological analysis of the removed piece of pancreas.
- if woman being of childbearing potential, woman taking contraceptive measures
- Patient able to understand benefits and risks of protocol
- Subject affiliated to French health insurance (Social Security)
- Informed consent form signed
Exclusion Criteria:
- Patients not fulfilling inclusion criteria
- Pancreatic surgery or radiotherapy in the pancreatic zone within 4 the months preceding the TEP-CT
- Chemotherapy within 2 the months preceding the TEP-CT
- Acute pancreatitis within 2 the months preceding the TEP-CT
- Pregnant women or breast-feeding women refusing to temporary stop it
- Diabetes not equilibrated (checked by glycemia and glycosylated hemoglobin (HbA1c) at inclusion) or Fasting blood glucose below 7mmol/L (126 g/L before the TEP)
- Patients with claustrophobia
- Patients not accepted under the anesthesia point of view
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: positrons emission tomography
|
18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Specificity of TEP-CT to point out malignant lesions in pancreas, the gold standard being the anatomopathological analysis of the piece of pancreas removed during the surgery.
Time Frame: 3 months
|
TEP-CT of the different 5 parts of the pancreas (head, uncus, isthmi, body and tail) will be interpreted by nuclearity Doctors. TEP-CT will be considered positive if there is a pathological fixation of the 18-FDG , defined as any focal or diffuse fixation of 18-FDG above the background level of fixation in the pancreas. The anatomopathological analysis of the piece of pancreas removed during the ablative surgery will be considered as positive if the degree of dysplasia seen for each part of the pancreas is "infiltrating carcinoma". Results will then be compared in term of specificity. |
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitivity of TEP-CT to point out malignant lesions in pancreas, the gold standard being the anatomopathological analysis of the piece of pancreas removed during the surgery.
Time Frame: 3 months
|
TEP-CT of the different 5 parts of the pancreas (head, uncus, isthmi, body and tail) will be interpreted by nuclearity Doctors. TEP-CT will be considered positive if there is a pathological fixation of the 18-FDG , defined as any focal or diffuse fixation of 18-FDG above the background level of fixation in the pancreas. The anatomopathological analysis of the piece of pancreas removed during the ablative surgery will be considered as positive if the degree of dysplasia seen for each part of the pancreas is "infiltrating carcinoma". Results will then be compared in term of sensitivity. |
3 months
|
|
Comparison of specificity of the TEP-CT to detect malignant lesions in pancreas versus specificity of conventional devices, the gold standard being the anatomopathological analysis results
Time Frame: 3 months
|
Result of conventional devices (such as computed tomography, magnetic resonance cholangiopancreatography or endoscopic ultrasound) will be considered positive if diagnosis is "malignant lesion" or "probable malignant lesion".
The 5 parts of the pancreas will be examined.
|
3 months
|
|
Number of patients for which metastasis will be detected through TEP-CT and confirmed by biopsy and/or conventional specific device
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
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
- BRD/10/06-P
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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