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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01485679
First Posted: December 5, 2011
Last Update Posted: May 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nantes University Hospital
August 26, 2011
December 5, 2011
May 18, 2016
January 2011
April 2015   (Final data collection date for primary outcome measure)
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 ]

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.

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 ]

TEP-CT of the different 5 parts of the pancreas (head, uncus, isthm, body and tail) will be interpreted by nuclearist 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 backgrownd 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.

Complete list of historical versions of study NCT01485679 on ClinicalTrials.gov Archive Site
  • 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 ]

    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 ]
    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 ]
  • 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 ]

    TEP-CT of the different 5 parts of the pancreas (head, uncus, isthm, body and tail) will be interpreted by nuclearist 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 backgrownd 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 ]
    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 ]
Not Provided
Not Provided
 
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.
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Tumor
Other: 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography
18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography
Experimental: positrons emission tomography
Intervention: Other: 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
April 2015
April 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01485679
BRD/10/06-P
Not Provided
Not Provided
Not Provided
Nantes University Hospital
Nantes University Hospital
Not Provided
Not Provided
Nantes University Hospital
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP