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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Tumor |
Other: 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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 |
- 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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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.
- 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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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 sensitivity.
- 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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]Result of conventional devices (such as computed tomography, magnetic resonance cholangiopancreatography or endoscopic ultrasound) will be considered positive if diagnosis is "malignant lesion" or "probable malignant lesion". The 5 parts of the pancreas will be examined.
- Number of patients for which metastasis will be detected through TEP-CT and confirmed by biopsy and/or conventional specific device [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 154 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: positrons emission tomography |
Other: 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography
18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Nicolas REGENET, MD | +33 2 40 08 30 17 | nicolas.regenet@chu-nantes.fr |
| France | |
| CHU Nord | Recruiting |
| Amiens, France, 80080 | |
| Contact: Jean Marc REGIMBEAU, Professor | |
| Principal Investigator: Jean-Marc REGIMBEAU, Pr | |
| Maison de Haut Lévêque CHU | Recruiting |
| Bordeaux, France, 33604 | |
| Contact: Antonio SACUNHA, Professor | |
| Hôpital Beaujon APHP | Recruiting |
| Clichy, France, 92110 | |
| Contact: Alain SAUVANET, Professor | |
| Hôpital C Huriez | Recruiting |
| Lille, France, 59037 | |
| Contact: Christophe MARIETTE, Professor | |
| Hospices Civils de Lyon | Recruiting |
| Lyon, France, 69437 | |
| Contact: Mustapha ADHAM, Professor | |
| CHU Nord | Recruiting |
| Marseille, France, 13915 | |
| Contact: Vincent MOUTARDIER, Professor | |
| Institut Paoli Calmettes | Recruiting |
| Marseille, France, 13273 | |
| Contact: Jean Robert DELPERO, Professor | |
| CHU | Recruiting |
| Nantes, France, 44093 | |
| Contact: Nicolas REGENET, MD | |
| Principal Investigator: Nicolas REGENET, Dr | |
| Hôpital St-Antoine | Recruiting |
| Paris, France, 75012 | |
| Contact: François PAYE, Pr +33 1 49 28 25 38 francois.paye@sat.ap-hop-paris.fr | |
| Principal Investigator: François PAYE, Pr | |
| CHU Hôpital Pontchaillou | Recruiting |
| Rennes, France, 35033 | |
| Contact: Bernard MEUNIER, Professor | |
| Hôpital de Hautepierre | Recruiting |
| Strasbourg, France, 67098 | |
| Contact: Patrick PESSAUX, Professor | |
| CHU Rangueil | Recruiting |
| Toulouse, France, 31059 | |
| Contact: Fabrice MUSCARI, Doctor +33 5 61 32 27 41 muscari.f@chu-toulouse.fr | |
| Principal Investigator: Fabrice MUSCARI, Doctor | |
More Information
No publications provided
| Responsible Party: | Nantes University Hospital |
| ClinicalTrials.gov Identifier: | NCT01485679 History of Changes |
| Other Study ID Numbers: | 10/6-P |
| Study First Received: | August 26, 2011 |
| Last Updated: | September 19, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Nantes University Hospital:
|
18 fluoro deoxy glucose positrons emission tomography combined with computed tomography, Patients with intraductal papillary mucinous tumor of the pancreas intraductal papillary mucinous pancreas |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Pancreatic Diseases Digestive System Diseases Endocrine System Diseases Deoxyglucose |
Pancreatin Pancrelipase Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antiviral Agents Anti-Infective Agents Therapeutic Uses Gastrointestinal Agents |
ClinicalTrials.gov processed this record on June 13, 2013