Status:
COMPLETED
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
Lead Sponsor:
Nantes University Hospital
Conditions:
Tumor
Eligibility:
All Genders
18+ years
Phase:
NA
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 tho...
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 comp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT01485679
Start Date
January 1 2011
End Date
April 1 2015
Last Update
May 18 2016
Active Locations (12)
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1
CHU Nord
Amiens, France, France, 80080
2
Maison de Haut Lévêque CHU
Bordeaux, France, France, 33604
3
Hôpital Beaujon APHP
Clichy, France, France, 92110
4
Hôpital C Huriez
Lille, France, France, 59037