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
=================
Brief Summary
-----------------
The aim of the study is to evaluate whether the TEP-CT can be sensitive and specific in identifying degenerated intraductal papillary mucinous tumor of the pancreas.The results will be compared to those obtained by the pathological analysis of the removed piece of pancreas.

Detailed Description
-----------------
Before surgery is undertaken, a 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography (18-FDG TEP-CT ) will be performed. The primary outcome of this study is to compare results of the TEP-CT with those obtained by the pathological analysis of the removed piece of pancreas.

Official Title
-----------------
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

Conditions
-----------------
Tumor

Intervention / Treatment
-----------------
* Other: 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: positrons emission tomography<br> | Other: 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography<br>* 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography<br>|

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. | 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. | 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 | 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 |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
18 fluoro deoxy glucose positrons emission tomography combined with computed tomography,, Patients with intraductal papillary mucinous tumor of the pancreas, intraductal papillary mucinous, pancreas