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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 1Z5
- University Health Network
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Investigation of 18F-FDG PET/MRI efficacy in differentiating pancreatic cystic neoplasms
Time Frame: 18 months
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18 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHN-16-6058
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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