Use of PET Imaging to Distinguish Malignant From Benign IPMN



Status:Recruiting
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 80
Updated:4/2/2016
Start Date:August 2009
End Date:December 2016
Contact:Masanori Ichise, MD
Email:mi2193@columbia.edu

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

Intraductal papillary mucinous neoplasm (IPMN) is a cystic pancreatic lesion 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
surgery to clinical observation. However, despite physicians' attempts to characterize
features concerning for malignancy, it is difficult to determine the likelihood of
malignancy with conventional imaging techniques, and an accurate and non-invasive test to
identify malignant IPMN is needed. Our hypothesis is that positron emission tomography
(PET), a three-dimensional imaging that can identify cancer cells through their increased
use of sugars, may be a superior test for differentiating between benign and malignant IPMN
lesions. The investigators are planning a prospective pilot study of patients with IPMN who
are undergoing surgery for their disease. These patients will undergo PET imaging, as well
as computed tomography (CT), magnetic resonance imaging (MRI), and endoscopic ultrasound
(EUS) as clinically indicated. Samples of tissue removed during surgery will be assessed and
will serve as the gold standard for determining whether the lesion is benign or malignant.
The investigators will evaluate the positive and negative predictive values of PET imaging
for malignancy within IPMN lesions.

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 standardized uptake value (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 noted.

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
level.

- 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.
We found this trial at
1
site
630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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from
New York, NY
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