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

Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01485679
• Other study ID #: BRD/10/06-P
• Status: Completed
• Phase: N/A
• First received: August 26, 2011
• Last updated: May 17, 2016
• Start date: January 2011
• Est. completion date: April 2015

Study information

• Verified date: October 2015
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Tumor

Intervention

Other:
• 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography
18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography

Locations

Country	Name	City	State
France	CHU Nord	Amiens
France	Maison de Haut Lévêque CHU	Bordeaux
France	Hôpital Beaujon APHP	Clichy
France	Hôpital C Huriez	Lille
France	Hospices Civils de Lyon	Lyon
France	CHU Nord	Marseille
France	Institut Paoli Calmettes	Marseille
France	CHU	Nantes
France	Hôpital St-Antoine	Paris
France	CHU Hôpital Pontchaillou	Rennes
France	Hôpital de Hautepierre	Strasbourg
France	CHU Rangueil	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	3 months	No
Secondary	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.	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.	3 months	No
Secondary	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	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.	3 months	No
Secondary	Number of patients for which metastasis will be detected through TEP-CT and confirmed by biopsy and/or conventional specific device		3 months	No