Clinical trial NCT01104116: Use of PET Imaging to Distinguish Malignant From Benign IPMN
Official title: Utility of [18F]-FDG PET Imaging to Distinguish Malignant From Benign Intrapapillary Mucinous Neoplasms
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neoplasm
Pancreatic Cancer
Keywords: Pancreatic Cancer
Intraductal Papillary Mucinous Neoplasm
Pre-cancerous pancreatic lesion
PET Scan
Pancreatic Cancer Screening
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2010-04-15
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Positive and Negative Predictive Value of PET Imaging for Identifying Malignant IPMN
timeFrame: 1 month
Secondary outcomes:
measure: Change in Lesion Characteristics to Assess Benefit of PET Scans
timeFrame: 1 month
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Chaitanya Divgi, MD
role: PRINCIPAL_INVESTIGATOR
References: