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

NCT ID: NCT01485679

Last Updated: 2016-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-04-30

Brief Summary

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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

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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.

Conditions

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Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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positrons emission tomography

Group Type EXPERIMENTAL

18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography

Intervention Type OTHER

18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography

Interventions

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18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography

18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography

Intervention Type OTHER

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Nord

Amiens, France, France

Site Status

Maison de Haut Lévêque CHU

Bordeaux, France, France

Site Status

Hôpital Beaujon APHP

Clichy, France, France

Site Status

Hôpital C Huriez

Lille, France, France

Site Status

Hospices Civils de Lyon

Lyon, France, France

Site Status

Institut Paoli Calmettes

Marseille, France, France

Site Status

CHU Nord

Marseille, France, France

Site Status

CHU

Nantes, France, France

Site Status

CHU Hôpital Pontchaillou

Rennes, France, France

Site Status

Hôpital de Hautepierre

Strasbourg, France, France

Site Status

Hôpital St-Antoine

Paris, , France

Site Status

CHU Rangueil

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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BRD/10/06-P

Identifier Type: -

Identifier Source: org_study_id

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