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Nonfunctional Pancreatic NET and PET Imaging

Primary Purpose

Diagnosis

Status
Unknown status
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
PET/CT
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diagnosis focused on measuring neuroendocrine tumor, pancreas, diagnosis, positron emission tomography

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • HUS VatsakeskusRecruiting
  • Turku Division of Digestive Surgery and UrologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Preoperative diagnosis

Arm Description

Preoperative diagnosis

Outcomes

Primary Outcome Measures

The SUV of 68Ga-DOTANOC and 18F-FDG PET-CT predict the malignant potential of P-NETs

Secondary Outcome Measures

Full Information

First Posted
November 24, 2015
Last Updated
January 5, 2016
Sponsor
Turku University Hospital
Collaborators
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02621541
Brief Title
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turku University Hospital
Collaborators
Helsinki University Central Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diagnosis
Keywords
neuroendocrine tumor, pancreas, diagnosis, positron emission tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preoperative diagnosis
Arm Type
Experimental
Arm Description
Preoperative diagnosis
Intervention Type
Device
Intervention Name(s)
PET/CT
Primary Outcome Measure Information:
Title
The SUV of 68Ga-DOTANOC and 18F-FDG PET-CT predict the malignant potential of P-NETs
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Saila Kauhanen
Phone
+358503017010
Email
saila.kauhanen@utu.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saila Kauhanen, MD, PhD
Organizational Affiliation
Turku University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
HUS Vatsakeskus
City
Helsinki
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanna Seppänen, MD, PhD
Facility Name
Turku Division of Digestive Surgery and Urology
City
Turku
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saila Kauhanen, MD, PhD
Phone
+358 503017010

12. IPD Sharing Statement

Citations:
PubMed Identifier
31872324
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.
Results Reference
derived

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Nonfunctional Pancreatic NET and PET Imaging

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