Clinical trial NCT01485679: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tumor
Keywords: 18 fluoro deoxy glucose positrons emission tomography combined with computed tomography,
Patients with intraductal papillary mucinous tumor of the pancreas
intraductal papillary mucinous
pancreas
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2011-12-05
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
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.
timeFrame: 3 months
Secondary outcomes:
measure: 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.
timeFrame: 3 months
measure: 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
timeFrame: 3 months
measure: Number of patients for which metastasis will be detected through TEP-CT and confirmed by biopsy and/or conventional specific device
timeFrame: 3 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Nord
city: Bordeaux
country: France
facility: Maison de Haut Lévêque CHU
city: Clichy
country: France
facility: Hôpital Beaujon APHP
city: Lille
country: France
facility: Hôpital C Huriez
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Marseille
country: France
facility: CHU Nord
city: Nantes
country: France
facility: CHU
city: Paris
country: France
facility: Hôpital St-Antoine
city: Rennes
country: France
facility: CHU Hôpital Pontchaillou
city: Strasbourg
country: France
facility: Hôpital de Hautepierre
city: Toulouse
country: France
facility: CHU Rangueil
Study officials:
References: