PET-CT in Diagnosis of Pancreatic Cystic Neoplasms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01317836
First received: March 16, 2011
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

Preoperative diagnosis of pancreatic cystic lesions remains a difficult problem in clinical practice. At present, the treatment planning in pancreatic cystic neoplasms is significantly restricted by the limited preoperative diagnosis. Ultrasonography (US), multidetector computed tomography (MDCT) and magnetic resonance imaging (MRI) are the conventional modalities in imaging of pancreatic cystic neoplasms, but by these methods the diagnostic accuracy still remains compromised. Furthermore, recently encouraging results have been obtained in pancreatic cystic neoplasms using 18F-fluoro-2-deoxyglucose positron emission tomography (18F-FDG-PET) The aim of the current project is to evaluate the possibility to enhance the diagnostic accuracy by using the combined 18F-FDG-PET-CT imaging in patients with pancreatic cystic neoplasms by combining PET-CT with MRI and MDCT.


Condition
Neoplasms
Pancreatic Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PET-CT in Diagnosis of Pancreatic Cystic Neoplasms

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • Predictive Value of PET/CT imaging for Identifying Malignant and Benign Pancreatic Cystic Lesions [ Time Frame: 1 mo ] [ Designated as safety issue: No ]
    To determine sensitivities, specificities, accuracy and positive/negative predictive values of PET/CT imaging for differentiating malignant and benign cystic lesions in patients who are to undergo surgical resection.


Secondary Outcome Measures:
  • To compare PET/CT to ERCP, MDCT and MRI-MRCP [ Time Frame: 1 mo ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: March 2011
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients having pancreatic cystic lesion

Detailed Description:

Today, in clinical practice the diagnosis pancreatic cystic neoplasms are based on MDCT, MRI and ERCP followed by surgical exploration. The information gained by conventional imaging modalities is restricted to the morphological details, which usually is insufficient for the definitive staging of the pancreatic cystic neoplasms. Based on these previous studies, it seems that PET especially combined with CT modality could improve the diagnostic accuracy of the pancreatic cystic lesions.

So far, there are only few cases published concerning the role of 18F-FDG-PET-CT in the differential diagnosis of cystic pancreatic lesions. Therefore, more studies are needed to determine the role of combined 18F-FDG-PET-CT in the diagnosis of pancreatic cystic lesions.

The aim of the current project is to evaluate the possibility to enhance the diagnostic accuracy by using the combined 18F-FDG-PET-CT imaging in patients with pancreatic cystic neoplasms by combining PET-CT with MRI and MDCT.

The study consists of 20-30 patients with pancreatic cystic neoplasms. The patients enrolled in the study will be imaged by MDCT, MRI combined with magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography (ERCP) and 18F-FDG-PET-CT followed by surgery or follow-up. The data will be collected between 2011 and 2013.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study subjects will be recruited from gastroenterological surgery department of Turku University Hospital with clinical suspicion of pancreatic cystic neoplasm.

Criteria

Inclusion Criteria:

  • suspicion of pancreatic cystic neoplasm using US, MDCT, MRI and/or ERCP
  • laparotomy planned because of the lesion
  • signed informed consent

Exclusion Criteria:

-

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01317836

Locations
Finland
Turku University Hospital
Turku, Finland, 20521
Sponsors and Collaborators
Turku University Hospital
Investigators
Principal Investigator: Saila Kauhanen, PhD Turku University Hospital
  More Information

No publications provided

Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT01317836     History of Changes
Other Study ID Numbers: PANCYST
Study First Received: March 16, 2011
Last Updated: February 14, 2014
Health Authority: Finland: Ethics Committee

Keywords provided by Turku University Hospital:
pancreatic cystic lesion
PET
PET-CT
diagnosis

Additional relevant MeSH terms:
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 21, 2014