18F-FDG PET/MR Imaging for Differentiation of Serous From Non-Serous Pancreatic Cystic Neoplasms: A Pilot Study

The overlap of morphological imaging features results in many incidentally detected pancreatic cystic neoplasms going undiagnosed, including benign serous cystic neoplasms (SCN) and potentially malignant mucinous lesions (nonserous). The diagnostic ambiguity then lead to invasive procedures such as endoscopic ultrasonography (EUS), unwarranted surgical resection on SCN lesions or the need for long term periodic surveillance with delayed diagnosis of potentially malignant nonserous lesions. Therefore, precise differentiation of SCN from nonserous cystic neoplasms is highly desirable.

The 18F-fluorodeoxyglucose (FDG) accumulation in tumor cells, which is induced by high expression of glucose transporter proteins (mainly include GLUT-1 and -3), can be used to discriminate malignant and benign pancreatic cystic tumors in positron emission tomography (PET) imaging. GLUT-1 expression has also been documented in benign SCN while no such evidence exists in potentially malignant nonserous cystic neoplasms. Based on this evidence, investigators will conduct a pilot study to evaluate if integrated 18F-FDG PET/MR imaging with simultaneous MR and PET acquisition is helpful in differentiation of SCN from nonserous lesions.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cystic Neoplasms
• Intervention / Treatment: Diagnostic test: PET scan

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1Z5
      • University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-Patients with known pancreatic cystic lesions, including suspected pancreatic serous cystic neoplasms and non-serous cystic neoplasms

Exclusion criteria:

• General Contraindications to MRI such as pacemaker, brain aneurysm clip etc. -
• Pregnancy
• Age below 18 years
• Estimated GFR (eGFR < 30 mL/min)
• MRI contrast allergy;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single Arm; In this project, there is only one study group which comprises of patients with pancreatic cystic neoplasms who will undergo pancreatic PET/MRI.	Diagnostic test: PET scan; Patients with known pancreatic cystic lesions requiring MR imaging for lesion characterization for clinical evaluation will be recruited to undergo 18F-FDG PET/MR imaging after written informed consent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Investigation of 18F-FDG PET/MRI efficacy in differentiating pancreatic cystic neoplasms	18 months

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2017
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: November 13, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 16, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: UHN-16-6058

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No