Nonfunctional Pancreatic NET and PET Imaging

Diagnosis Clinical Trial

Official title:

Dual Tracer Functional Imaging of Nonfunctional Pancreatic Neuroendocrine Tumors Using 68Ga-DOTA-NOC and 18F-FDG PET/CT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02621541
• Other study ID #: P-NETPET
• Status: Recruiting
• Phase: Phase 4
• First received: November 24, 2015
• Last updated: January 5, 2016
• Start date: December 2015
• Est. completion date: February 2019

Study information

• Verified date: January 2016
• Source: Turku University Hospital
• Contact: Saila Kauhanen
• Phone: +358503017010
• Email: saila.kauhanen[@]utu.fi
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoid Tumor
• Diagnosis
• Neuroendocrine Tumors

Intervention

Device:
• PET/CT

Locations

Country	Name	City	State
Finland	HUS Vatsakeskus	Helsinki
Finland	Turku Division of Digestive Surgery and Urology	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The SUV of 68Ga-DOTANOC and 18F-FDG PET-CT predict the malignant potential of P-NETs		2 years	No