PET-CT in Diagnosis of Pancreatic Cystic Neoplasms
Recruitment status was Recruiting
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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 |
- 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.
- To compare PET/CT to ERCP, MDCT and MRI-MRCP [ Time Frame: 1 mo ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 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 |
The study subjects will be recruited from gastroenterological surgery department of Turku University Hospital with clinical suspicion of pancreatic cystic neoplasm.
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| Contact: Saila Kauhanen, PhD | +358 2 313 0209 | saila.kauhanen@utu.fi |
| Contact: Jari Ovaska, PhD | +358 2 313 0000 | jari.ovaska@tyks.fi |
| Finland | |
| Turku University Hospital | Recruiting |
| Turku, Finland, 20521 | |
| Contact: Saila Kauhanen, PhD +358 2 313 0209 saila.kauhanen@utu.fi | |
| Contact: Jari Ovaska, PhD +358 2 313 0000 jari.ovaska@tyks.fi | |
| Principal Investigator: Saila Kauhanen, PhD | |
| Principal Investigator: | Saila Kauhanen, PhD | Turku University Hospital |
More Information
No publications provided
| Responsible Party: | Turku University Hospital, Turku (PhD Saila Kauhanen), Turku University Hospital |
| ClinicalTrials.gov Identifier: | NCT01317836 History of Changes |
| Other Study ID Numbers: | PANCYST |
| Study First Received: | March 16, 2011 |
| Last Updated: | March 16, 2011 |
| 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 May 16, 2013