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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Tumor

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

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.

Outcome Description:

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.

Outcome Time Frame:

3 months

Safety Issue:

No

Authority:

France: Ministry of Health

Study ID:

10/6-P

NCT ID:

NCT01485679

Start Date:

January 2011

Completion Date:

April 2014

Related Keywords:

  • Tumor
  • 18 fluoro deoxy glucose positrons emission tomography combined with computed tomography,
  • Patients with intraductal papillary mucinous tumor of the pancreas
  • intraductal papillary mucinous
  • pancreas
  • Pancreatic Neoplasms

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