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

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.

Study Overview

• Status: Completed
• Conditions: Tumor
• Intervention / Treatment: Other: 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography

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 Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • 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
    • Hopital de Hautepierre
  • Toulouse, France, 31059
    • CHU Rangueil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: positrons emission tomography	Other: 18 fluoro-deoxy-glucose positrons emission tomography combined with computed 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.	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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: August 26, 2011
• First Submitted That Met QC Criteria: December 1, 2011
• First Posted (Estimate): December 5, 2011

Study Record Updates

• Last Update Posted (Estimate): May 18, 2016
• Last Update Submitted That Met QC Criteria: May 17, 2016
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: pancreas; 18 fluoro deoxy glucose positrons emission tomography combined with computed tomography,; Patients with intraductal papillary mucinous tumor of the pancreas; intraductal papillary mucinous
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Deoxyglucose
• Other Study ID Numbers: BRD/10/06-P

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No