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

Nantes University Hospital126 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

126

Conditions

Tumor

Interventions

18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomographyOTHER

18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

CHU Nord

Amiens, France, France

Maison de Haut Lévêque CHU

Bordeaux, France, France

Hôpital Beaujon APHP

Clichy, France, France

Hôpital C Huriez

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

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

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.

Time frame: 3 months

Data from ClinicalTrials.gov

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