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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01485679
First received: August 26, 2011
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Tumor
Other: 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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:
  • 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 ] [ Designated as safety issue: No ]

    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 106
Study Start Date: January 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485679

Contacts
Contact: Nicolas REGENET, MD +33 2 40 08 30 17 nicolas.regenet@chu-nantes.fr

Locations
France
CHU Nord Recruiting
Amiens, France, 80080
Contact: Jean Marc REGIMBEAU, Professor         
Principal Investigator: Jean-Marc REGIMBEAU, Pr         
Maison de Haut Lévêque CHU Recruiting
Bordeaux, France, 33604
Contact: Antonio SACUNHA, Professor         
Hôpital Beaujon APHP Recruiting
Clichy, France, 92110
Contact: Alain SAUVANET, Professor         
Hôpital C Huriez Recruiting
Lille, France, 59037
Contact: Christophe MARIETTE, Professor         
Hospices Civils de Lyon Recruiting
Lyon, France, 69437
Contact: Mustapha ADHAM, Professor         
CHU Nord Recruiting
Marseille, France, 13915
Contact: Vincent MOUTARDIER, Professor         
Institut Paoli Calmettes Recruiting
Marseille, France, 13273
Contact: Jean Robert DELPERO, Professor         
CHU Recruiting
Nantes, France, 44093
Contact: Nicolas REGENET, MD         
Principal Investigator: Nicolas REGENET, Dr         
Hôpital St-Antoine Recruiting
Paris, France, 75012
Contact: François PAYE, Pr    +33 1 49 28 25 38    francois.paye@sat.ap-hop-paris.fr   
Principal Investigator: François PAYE, Pr         
CHU Hôpital Pontchaillou Recruiting
Rennes, France, 35033
Contact: Bernard MEUNIER, Professor         
Hôpital de Hautepierre Recruiting
Strasbourg, France, 67098
Contact: Patrick PESSAUX, Professor         
CHU Rangueil Recruiting
Toulouse, France, 31059
Contact: Fabrice MUSCARI, Doctor    +33 5 61 32 27 41    muscari.f@chu-toulouse.fr   
Principal Investigator: Fabrice MUSCARI, Doctor         
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01485679     History of Changes
Other Study ID Numbers: 10/6-P
Study First Received: August 26, 2011
Last Updated: February 5, 2014
Health Authority: France: Ministry of Health

Keywords provided by Nantes University Hospital:
18 fluoro deoxy glucose positrons emission tomography combined with computed tomography,
Patients with intraductal papillary mucinous tumor of the pancreas
intraductal papillary mucinous
pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Deoxyglucose
Pancreatin
Pancrelipase
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 22, 2014