Clinical trial NCT02621541: Nonfunctional Pancreatic NET and PET Imaging
Official title: Dual Tracer Functional Imaging of Nonfunctional Pancreatic Neuroendocrine Tumors Using 68Ga-DOTA-NOC and 18F-FDG PET/CT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diagnosis
Keywords: neuroendocrine tumor
pancreas
diagnosis
positron emission tomography
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Helsinki University Central Hospital
First posted: 2015-12-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* suspicion of nonfunctional P-NET on primary CT (i.e hypervascularity) or MRI
* signed informed consent

Exclusion Criteria:

* vulnerable study subjects such as described in Finnish law concerning clinical studies (disabled, children, pregnant or breast-feeding women, prisoners) will not be included.

Primary outcomes:
measure: The SUV of 68Ga-DOTANOC and 18F-FDG PET-CT predict the malignant potential of P-NETs
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: HUS Vatsakeskus
city: Turku
country: Finland
facility: Turku Division of Digestive Surgery and Urology
Study officials:
affiliation: Turku University Hospital
name: Saila Kauhanen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Majala S, Seppanen H, Kemppainen J, Sundstrom J, Schalin-Jantti C, Gullichsen R, Schildt J, Mustonen H, Vesterinen T, Arola J, Kauhanen S. Prediction of the aggressiveness of non-functional pancreatic neuroendocrine tumors based on the dual-tracer PET/CT. EJNMMI Res. 2019 Dec 23;9(1):116. doi: 10.1186/s13550-019-0585-7.