PET-CT in Diagnosis of Pancreatic Cystic Neoplasms

NCT ID: NCT01317836

Last Updated: 2014-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neoplasms Pancreatic Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients having pancreatic cystic lesion

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Saila Kauhanen, PhD

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Turku University Hospital

Turku, , Finland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Finland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PANCYST

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.