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

Not Applicable

Completed

• Conditions: Tumor
• Interventions: Other: 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography

• Registration Number: NCT01485679
• Lead Sponsor: Nantes University Hospital

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-08-26
• Study First Submitted QC: 2011-12-01
• Study First Posted: 2011-12-05
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-10
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
positrons emission tomography	18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
Number of patients for which metastasis will be detected through TEP-CT and confirmed by biopsy and/or conventional specific device	3 months

Trial Locations

Locations (11)

CHU Nord; 🇫🇷 Marseille, France

Maison de Haut Lévêque CHU; 🇫🇷 Bordeaux, France

Hôpital Beaujon APHP; 🇫🇷 Clichy, France

Hôpital C Huriez; 🇫🇷 Lille, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

CHU; 🇫🇷 Nantes, France

Hôpital St-Antoine; 🇫🇷 Paris, France

CHU Hôpital Pontchaillou; 🇫🇷 Rennes, France

Hôpital de Hautepierre; 🇫🇷 Strasbourg, France

CHU Rangueil; 🇫🇷 Toulouse, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France