18F-FDG PET/MR Imaging for Differentiation of Serous From Non-Serous Pancreatic Cystic Neoplasms: A Pilot Study
Primary Purpose
Pancreatic Cystic Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PET scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Pancreatic Cystic Neoplasms
Eligibility Criteria
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;
Sites / Locations
- University Health Network
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single Arm
Arm Description
In this project, there is only one study group which comprises of patients with pancreatic cystic neoplasms who will undergo pancreatic PET/MRI.
Outcomes
Primary Outcome Measures
Investigation of 18F-FDG PET/MRI efficacy in differentiating pancreatic cystic neoplasms
Secondary Outcome Measures
Full Information
NCT ID
NCT03352037
First Posted
November 13, 2017
Last Updated
April 16, 2021
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT03352037
Brief Title
18F-FDG PET/MR Imaging for Differentiation of Serous From Non-Serous Pancreatic Cystic Neoplasms: A Pilot Study
Official Title
18F-FDG PET/MR Imaging for Differentiation of Serous From Non-Serous Pancreatic Cystic Neoplasms: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cystic Neoplasms
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Other
Arm Description
In this project, there is only one study group which comprises of patients with pancreatic cystic neoplasms who will undergo pancreatic PET/MRI.
Intervention Type
Diagnostic Test
Intervention Name(s)
PET scan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Investigation of 18F-FDG PET/MRI efficacy in differentiating pancreatic cystic neoplasms
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kartik Jhaveri, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
18F-FDG PET/MR Imaging for Differentiation of Serous From Non-Serous Pancreatic Cystic Neoplasms: A Pilot Study
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