NCT01485679

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 5, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 18, 2016

Status Verified

October 1, 2015

Enrollment Period

4.2 years

First QC Date

August 26, 2011

Last Update Submit

May 17, 2016

Conditions

Tumor

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • 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.

    3 months

  • 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

    3 months

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

    3 months

Study Arms (1)

positrons emission tomography

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

Interventions

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

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

positrons emission tomography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Patients with claustrophobia
  • Patients not accepted under the anesthesia point of view

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

CHU Nord

Amiens, France, 80080, France

Location

Maison de Haut Lévêque CHU

Bordeaux, France, 33604, France

Location

Hôpital Beaujon APHP

Clichy, France, 92110, France

Location

Hôpital C Huriez

Lille, France, 59037, France

Location

Hospices Civils de Lyon

Lyon, France, 69437, France

Location

Institut Paoli Calmettes

Marseille, France, 13273, France

Location

CHU Nord

Marseille, France, 13915, France

Location

CHU

Nantes, France, 44093, France

Location

CHU Hôpital Pontchaillou

Rennes, France, 35033, France

Location

Hôpital de Hautepierre

Strasbourg, France, 67098, France

Location

Hôpital St-Antoine

Paris, 75012, France

Location

CHU Rangueil

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2011

First Posted

December 5, 2011

Study Start

January 1, 2011

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

May 18, 2016

Record last verified: 2015-10

Locations

FR(12)