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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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

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

About this trial

This is an interventional diagnostic trial for Tumor focused on measuring 18 fluoro deoxy glucose positrons emission tomography combined with computed tomography,, Patients with intraductal papillary mucinous tumor of the pancreas, intraductal papillary mucinous, pancreas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

positrons emission tomography

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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

Full Information

NCT ID

NCT01485679

First Posted

August 26, 2011

Last Updated

May 17, 2016

Sponsor

Nantes University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01485679

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nantes University Hospital

4. Oversight

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tumor

Keywords

18 fluoro deoxy glucose positrons emission tomography combined with computed tomography,, Patients with intraductal papillary mucinous tumor of the pancreas, intraductal papillary mucinous, pancreas

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

126 (Actual)

8. Arms, Groups, and Interventions

Arm Title

positrons emission tomography

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

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.

Description

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.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

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.

Description

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.

Time Frame

3 months

Title

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

Description

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.

Time Frame

3 months

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Facility Information:

Facility Name

CHU Nord

City

Amiens

ZIP/Postal Code

80080

Country

France

Facility Name

Maison de Haut Lévêque CHU

City

Bordeaux

ZIP/Postal Code

33604

Country

France

Facility Name

Hôpital Beaujon APHP

City

Clichy

ZIP/Postal Code

92110

Country

France

Facility Name

Hôpital C Huriez

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

Hospices Civils de Lyon

City

Lyon

ZIP/Postal Code

69437

Country

France

Facility Name

Institut Paoli Calmettes

City

Marseille

ZIP/Postal Code

13273

Country

France

Facility Name

CHU Nord

City

Marseille

ZIP/Postal Code

13915

Country

France

Facility Name

CHU

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

Hôpital St-Antoine

City

Paris

ZIP/Postal Code

75012

Country

France

Facility Name

CHU Hôpital Pontchaillou

City

Rennes

ZIP/Postal Code

35033

Country

France

Facility Name

Hôpital de Hautepierre

City

Strasbourg

ZIP/Postal Code

67098

Country

France

Facility Name

CHU Rangueil

City

Toulouse

ZIP/Postal Code

31059

Country

France

Tumor

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial