Use of PET Imaging to Distinguish Malignant From Benign IPMN

• Sponsor: Columbia University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01104116
• Collaborator: National Center for Research Resources (NCRR) (NIH)
• Enrollment: 1
• Location: 1
• Arm: 1
• Duration (Months): 78
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasm; Pancreatic Cancer	Radiation: [18F]-FDG PET/CT imaging	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Utility of [18F]-FDG PET Imaging to Distinguish Malignant From Benign Intrapapillary Mucinous Neoplasms
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PET/CT imaging Surgical patients will undergo [18F]-FDG PET/CT imaging	Radiation: [18F]-FDG PET/CT imaging; Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)

Outcome Measures

Primary Outcome Measures

1. Positive and Negative Predictive Value of PET Imaging for Identifying Malignant IPMN [1 month]

   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.

Secondary Outcome Measures

1. Change in Lesion Characteristics to Assess Benefit of PET Scans [1 month]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Medical Center	New York	New York	United States	10032

Sponsors and Collaborators

• Columbia University
• National Center for Research Resources (NCRR)

Investigators

• Principal Investigator: Chaitanya Divgi, MD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Columbia University
• ClinicalTrials.gov Identifier: NCT01104116
• Other Study ID Numbers: AAAD9508; UL1RR024156
• First Posted: Apr 15, 2010
• Last Update Posted: Sep 15, 2016
• Last Verified: Jul 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Columbia University: Pancreatic Cancer; Intraductal Papillary Mucinous Neoplasm; Pre-cancerous pancreatic lesion; PET Scan; Pancreatic Cancer Screening
• Additional relevant MeSH terms: Neoplasms; Pancreatic Neoplasms

Study Results

Participant Flow

Recruitment Details	The principal investigator has left the institution. Data will not be analyzed. Only the demographic information on 1 enrolled subject is available.

Arm/Group Title	PET/CT Imaging
Arm/Group Description	Surgical patients will undergo [18F]-FDG PET/CT imaging [18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)
Period Title: Overall Study
STARTED	1
COMPLETED	1
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	PET/CT Imaging
Arm/Group Description	Surgical patients will undergo [18F]-FDG PET/CT imaging [18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)
Overall Participants	1
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	1 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	1 100%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Positive and Negative Predictive Value of PET Imaging for Identifying Malignant IPMN
Description	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.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

The principal investigator has left the institution. Data will not be analyzed. Only the demographic information on 1 enrolled subject is available.

Arm/Group Title	PET/CT Imaging
Arm/Group Description	Surgical patients will undergo [18F]-FDG PET/CT imaging [18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)
Measure Participants	0

2. Secondary Outcome

Title	Change in Lesion Characteristics to Assess Benefit of PET Scans
Description	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.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

The principal investigator has left the institution. Data will not be analyzed. Only the demographic information on 1 enrolled subject is available.

Arm/Group Title	PET/CT Imaging
Arm/Group Description	Surgical patients will undergo [18F]-FDG PET/CT imaging [18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)
Measure Participants	0

Adverse Events

Adverse Event Reporting Description	The principal investigator has left the institution. Data will not be analyzed. Only the demographic information on 1 enrolled subject is available.
Arm/Group Title	PET/CT Imaging
Arm/Group Description	Surgical patients will undergo [18F]-FDG PET/CT imaging [18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)
All Cause Mortality
	PET/CT Imaging
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	PET/CT Imaging
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	PET/CT Imaging
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.