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
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