- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01317836
PET-CT in Diagnosis of Pancreatic Cystic Neoplasms
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
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Turku, Finland, 20521
- Turku University Hospital
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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:
-
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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Patients having pancreatic cystic lesion
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Predictive Value of PET/CT imaging for Identifying Malignant and Benign Pancreatic Cystic Lesions
Tidsramme: 1 mo
|
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.
|
1 mo
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
To compare PET/CT to ERCP, MDCT and MRI-MRCP
Tidsramme: 1 mo
|
1 mo
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Saila Kauhanen, PhD, Turku University Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PANCYST
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