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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
Sponsor:
Collaborator:
Helsinki University Central Hospital
Information provided by (Responsible Party):
Turku University Hospital

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.


Condition or disease Intervention/treatment Phase
Diagnosis Device: PET/CT Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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


Arm Intervention/treatment
Experimental: Preoperative diagnosis
Preoperative diagnosis
Device: PET/CT



Primary Outcome Measures :
  1. The SUV of 68Ga-DOTANOC and 18F-FDG PET-CT predict the malignant potential of P-NETs [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Saila Kauhanen +358503017010 saila.kauhanen@utu.fi

Locations
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Finland
HUS Vatsakeskus Recruiting
Helsinki, Finland
Contact: Hanna Seppänen, MD, PhD         
Turku Division of Digestive Surgery and Urology Recruiting
Turku, Finland
Contact: Saila Kauhanen, MD, PhD    +358 503017010      
Sponsors and Collaborators
Turku University Hospital
Helsinki University Central Hospital
Investigators
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Principal Investigator: Saila Kauhanen, MD, PhD Turku University Hospital

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Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT02621541     History of Changes
Other Study ID Numbers: P-NETPET
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: January 6, 2016
Last Verified: January 2016
Keywords provided by Turku University Hospital:
neuroendocrine tumor
pancreas
diagnosis
positron emission tomography
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue