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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

Information source: Nantes University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tumor

Intervention: 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Nantes University Hospital

Overall contact:
Nicolas REGENET, MD, Phone: +33 2 40 08 30 17, Email: nicolas.regenet@chu-nantes.fr

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.

Clinical Details

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

Primary outcome: 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.

Secondary outcome:

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.

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

Number of patients for which metastasis will be detected through TEP-CT and confirmed by biopsy and/or conventional specific device

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Nicolas REGENET, MD, Phone: +33 2 40 08 30 17, Email: nicolas.regenet@chu-nantes.fr

CHU Nord, Amiens 80080, France; Recruiting
Jean Marc REGIMBEAU, Professor
Jean-Marc REGIMBEAU, Pr, Principal Investigator

Maison de Haut Lévêque CHU, Bordeaux 33604, France; Recruiting
Antonio SACUNHA, Professor

Hôpital Beaujon APHP, Clichy 92110, France; Recruiting
Alain SAUVANET, Professor

Hôpital C Huriez, Lille 59037, France; Recruiting
Christophe MARIETTE, Professor

Hospices Civils de Lyon, Lyon 69437, France; Recruiting
Mustapha ADHAM, Professor

CHU Nord, Marseille 13915, France; Recruiting
Vincent MOUTARDIER, Professor

Institut Paoli Calmettes, Marseille 13273, France; Recruiting
Jean Robert DELPERO, Professor

CHU, Nantes 44093, France; Recruiting
Nicolas REGENET, MD
Nicolas REGENET, Dr, Principal Investigator

Hôpital St-Antoine, Paris 75012, France; Recruiting
François PAYE, Pr, Phone: +33 1 49 28 25 38, Email: francois.paye@sat.ap-hop-paris.fr
François PAYE, Pr, Principal Investigator

CHU Hôpital Pontchaillou, Rennes 35033, France; Recruiting
Bernard MEUNIER, Professor

Hôpital de Hautepierre, Strasbourg 67098, France; Recruiting
Patrick PESSAUX, Professor

CHU Rangueil, Toulouse 31059, France; Recruiting
Fabrice MUSCARI, Doctor, Phone: +33 5 61 32 27 41, Email: muscari.f@chu-toulouse.fr
Fabrice MUSCARI, Doctor, Principal Investigator

Additional Information

Starting date: January 2011
Last updated: February 5, 2014

Page last updated: August 23, 2015

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