Nonfunctional Pancreatic NET and PET Imaging

NCT ID: NCT02621541

Last Updated: 2016-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2019-02-28

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.

Conditions

Diagnosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Preoperative diagnosis

Preoperative diagnosis

Group Type: EXPERIMENTAL

PET/CT

Intervention Type: DEVICE

Interventions

PET/CT

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saila Kauhanen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Locations

Turku Division of Digestive Surgery and Urology

Turku, Turku, Finland

Site Status: RECRUITING

HUS Vatsakeskus

Helsinki, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Saila Kauhanen

Role: CONTACT

saila.kauhanen@utu.fi

+358503017010

Facility Contacts

Saila Kauhanen, MD, PhD

Role: primary

+358 503017010

Hanna Seppänen, MD, PhD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 31872324 (View on PubMed)

Other Identifiers

P-NETPET

Identifier Type: -

Identifier Source: org_study_id