Tumor
Conditions
Keywords
18 fluoro deoxy glucose positrons emission tomography combined with computed tomography,, Patients with intraductal papillary mucinous tumor of the pancreas, intraductal papillary mucinous, pancreas
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.
Interventions
OTHER18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography
18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography
Sponsors
Nantes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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 | 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. |
| Number of patients for which metastasis will be detected through TEP-CT and confirmed by biopsy and/or conventional specific device | 3 months | — |
Countries
France
Outcome results
None listed