NCT02621541

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2015

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

January 6, 2016

Status Verified

January 1, 2016

Enrollment Period

3 years

First QC Date

November 24, 2015

Last Update Submit

January 5, 2016

Conditions

Diagnosis

Keywords

neuroendocrine tumorpancreasdiagnosispositron emission tomography

Outcome Measures

Primary Outcomes (1)

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

    2 years

Study Arms (1)

Preoperative diagnosis

EXPERIMENTAL

Preoperative diagnosis

Device: PET/CT

Interventions

PET/CTDEVICE
Preoperative diagnosis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Turku Division of Digestive Surgery and Urology

Turku, Turku, Finland

RECRUITING

HUS Vatsakeskus

Helsinki, Finland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31872324DERIVED

MeSH Terms

Conditions

DiseaseNeuroendocrine Tumors

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Saila Kauhanen, MD, PhD

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Saila Kauhanen

CONTACT

+358503017010saila.kauhanen@utu.fi

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2015

First Posted

December 3, 2015

Study Start

December 1, 2015

Primary Completion

December 1, 2018

Study Completion

February 1, 2019

Last Updated

January 6, 2016

Record last verified: 2016-01

Locations

FI(2)