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Utility of [18F]-FDG PET Imaging to Distinguish Malignant From Benign Intrapapillary Mucinous Neoplasms

18 Years
80 Years
Open (Enrolling)
Neoplasm, Pancreatic Cancer

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Trial Information

Utility of [18F]-FDG PET Imaging to Distinguish Malignant From Benign Intrapapillary Mucinous Neoplasms

Intraductal papillary mucinous neoplasm (IPMN) is a cystic pancreatic neoplasm that is a
precursor to invasive pancreatic cancer. Differentiating whether an IPMN lesion is benign or
malignant is critical, as the prognosis and management differs drastically, varying from
surgical resection to observation. However, despite attempts to characterize features
concerning for malignancy, it is difficult to determine the likelihood of malignancy with
conventional imaging techniques, including CT, MRI, and EUS. An accurate, non-invasive test
to identify malignant IPMN is needed.

The investigators' hypothesis is that [18F]-FDG PET may be a superior modality for
differentiating between benign and malignant IPMN lesions. We are planning a prospective
pilot study of ten consecutive patients with IPMN from the Columbia University Pancreas
Center who are undergoing surgical resection for their disease. These patients will undergo
[18F]-FDG PET imaging, as well as CT, MRI, and EUS as clinically indicated. All scans will
be reviewed by two experienced nuclear medicine radiologists who will be blinded to the
clinical characteristics of study patients and who will reach a consensus. Areas of focally
increased [18F]-FDG intake will be identified. Side-by-side reading with CT scan will be
performed to evaluate whether the increased [18F]-FDG uptake corresponds to a pancreatic
lesion. Mean and maximal SUV values, as well as differences in intensity between the region
of interest and the remaining pancreas, will be calculated.Surgical pathology will be
utilized as the gold standard for histological determination. Standard post-operative
histological interpretation of each IPMN lesion will be recorded, including size, duct
involvement (main, side, or mixed), ductal dilatation, lesion location (head, neck, body,
tail), and histologic grade (adenoma, borderline, carcinoma in situ, invasive carcinoma). In
addition, any associated pancreatitis or any other non-IPMN neoplastic change will also be

Using PET scan results and surgical pathology information, we will evaluate the positive and
negative predictive values of [18F]-FDG PET for malignancy within IPMN lesions.

Inclusion Criteria:

- Patient is seen in consultation for IPMN at Columbia-Presbyterian Medical Center and
scheduled for surgical resection.

- Patient has radiological evidence, by CT or MRI, suspicious for IPMN, with cystic
lesion involving main duct of size equal to or greater than 3 cm and/or involvement
of at least a 3 cm segment of the main pancreatic duct.

- Patient has undergone EUS with aspiration of cyst fluid with sufficient fluid for CEA

- Patient is at least 18 years of age.

- Patient is able to provide written, informed consent.

Exclusion Criteria:

- Active pancreatitis within 30 days of recruitment.

- Uncontrolled diabetes mellitus.

- Pregnancy or breastfeeding (urine beta-HCG will be performed on all women of
child-bearing age prior to enrollment in study).

- Unwillingness or inability to sign informed consent.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Positive and Negative Predictive Value of PET imaging for Identifying Malignant IPMN

Outcome Description:

The primary outcome will be to determine the positive and negative predictive values of [18F]-FDG PET imaging for identifying malignant IPMN lesions in patients who are to undergo surgical resection. We will determine the mean SUV that would provide optimal positive predictive value for malignant IPMN. IPMN lesions will be classified categorically as benign (adenoma or borderline ) or malignant (in situ or invasive carcinoma) and PET imaging will be classified categorically as negative or positive, with focal FDG uptake corresponding to pancreatic lesion.

Outcome Time Frame:

1 month

Safety Issue:


Principal Investigator

Masanori Ichise, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Institutional Review Board

Study ID:




Start Date:

February 2009

Completion Date:

October 2013

Related Keywords:

  • Neoplasm
  • Pancreatic Cancer
  • Pancreatic Cancer
  • Intraductal Papillary Mucinous Neoplasm
  • Pre-cancerous pancreatic lesion
  • PET Scan
  • Pancreatic Cancer Screening
  • Neoplasms
  • Pancreatic Neoplasms



Columbia University Medical Center New York, New York  10032