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

NCT ID: NCT03352037

Last Updated: 2021-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-15
• Study Completion Date: 2018-07-31

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.

Conditions

Pancreatic Cystic Neoplasms

Study Design

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

Study Groups

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.

Group Type: OTHER

PET scan

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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;

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

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kartik Jhaveri, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

University Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

UHN-16-6058

Identifier Type: -

Identifier Source: org_study_id