Use of PET Imaging to Distinguish Malignant From Benign IPMN

Stopped early · Not applicable

Conditions studied: Neoplasm, Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT01104116

Run by

Columbia University

People needed

1

Starts

2009-09-01

Expected to finish

2016-03-01

Last updated by the study team

2016-09-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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