Pancreatic Cancer Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | December 2016 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | National Center for Research Resources (NCRR) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Positive and Negative Predictive Value of PET imaging for Identifying Malignant IPMN | 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. | 1 month | No |
Secondary | Change in lesion characteristics to assess benefit of PET scans | The secondary outcome that we are interested in studying is the benefit of PET scan as compared to other imaging modalities, such as CT, MRI, and EUS. Thus, Patients will also have CT, MRI, and EUS imaging. We will look at how size, location, and branch of the IPMN lesion on PET compare to these other imaging modalities. The location, size, and pathology results of the actual surgical specimen will serve as the gold standard. | 1 month | No |
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