Nonfunctional Pancreatic NET and PET Imaging
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|ClinicalTrials.gov Identifier: NCT02621541|
Recruitment Status : Unknown
Verified January 2016 by Turku University Hospital.
Recruitment status was: Recruiting
First Posted : December 3, 2015
Last Update Posted : January 6, 2016
Predicting aggressive behavior in the group of nonfunctional pancreatic neuroendocrine tumors (NF P-NET) remains a difficult problem in clinical practice. At present, the treatment planning in P-NET is significantly restricted by the limited results of conventional imaging. In addition, increasing use of multidetector computed tomography (MDCT) and magnetic resonance imaging (MRI) is increasing the number of NF P-NETs detected. Somatostatin receptor scintigraphy (SRS) combined with anatomical imaging are the conventional modalities in imaging of P-NET, but by these methods the diagnostic accuracy still remains compromised. Furthermore, recently encouraging results have been obtained in P-NET using 68Ga-labelled somatostatin analog, DOTA-1-NaI3-octreotide (68Ga-DOTANOC) positron emission tomography-computed tomography (PET-CT).
The aim of the current project is to evaluate the possibility to enhance the diagnostic accuracy by using dual trace functional imaging 18F-labelled fluorodeoxyglucose (18F-FDG) and 68Ga-DOTANOC PET-CT imaging in patients with NF P-NET. The study consists of 20 patients with NF P-NET. The patients enrolled in the study will be imaged 68Ga-DOTANOC and 18F-FDG PET-CT followed by surgery or follow-up with endoscopic ultrasonography (EUS) biopsies. The data will be collected between autumn 2015 and spring 2018.
|Condition or disease||Intervention/treatment||Phase|
|Diagnosis||Device: PET/CT||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dual Tracer Functional Imaging of Nonfunctional Pancreatic Neuroendocrine Tumors Using 68Ga-DOTA-NOC and 18F-FDG PET/CT|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||February 2019|
Experimental: Preoperative diagnosis
- The SUV of 68Ga-DOTANOC and 18F-FDG PET-CT predict the malignant potential of P-NETs [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02621541
|Contact: Saila Kauhanenfirstname.lastname@example.org|
|Contact: Hanna Seppänen, MD, PhD|
|Turku Division of Digestive Surgery and Urology||Recruiting|
|Contact: Saila Kauhanen, MD, PhD +358 503017010|
|Principal Investigator:||Saila Kauhanen, MD, PhD||Turku University Hospital|