Use of PET Imaging to Distinguish Malignant From Benign IPMN

NCT01104116 | Terminated Results DMC

• 2 other identifiers: AAAD9508UL1RR024156
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasm; Pancreatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in Lesion Characteristics to Assess Benefit of PET Scans

  1 month

Study Arms (1)

PET/CT imaging

EXPERIMENTAL

Surgical patients will undergo \[18F\]-FDG PET/CT imaging

Radiation: [18F]-FDG PET/CT imaging

Interventions

[18F]-FDG PET/CT imaging RADIATION

Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)

PET/CT imaging

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Columbia University: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: CU PRS Administrator
• Organization: Columbia University

crchelp@columbia.edu

212-342-1643

Study Officials

• Chaitanya Divgi, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 15, 2010
• Study Start: September 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: March 1, 2016
• Last Updated: September 15, 2016
• Results First Posted: September 15, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)