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| ID | Type | Description | Link |
|---|---|---|---|
| UL1RR024156 | U.S. NIH Grant/Contract | View source |
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Poor enrollment; PI left the institution
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET/CT imaging | Experimental | Surgical patients will undergo [18F]-FDG PET/CT imaging |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]-FDG PET/CT imaging | Radiation | Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chaitanya Divgi, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
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The principal investigator has left the institution. Data will not be analyzed. Only the demographic information on 1 enrolled subject is available.
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| ID | Title | Description |
|---|---|---|
| FG000 | PET/CT Imaging | Surgical patients will undergo [18F]-FDG PET/CT imaging [18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | PET/CT Imaging | Surgical patients will undergo [18F]-FDG PET/CT imaging [18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG) |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
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| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The principal investigator has left the institution. Data will not be analyzed. Only the demographic information on 1 enrolled subject is available. | Posted | 1 month |
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The principal investigator has left the institution. Data will not be analyzed. Only the demographic information on 1 enrolled subject is available.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PET/CT Imaging | Surgical patients will undergo [18F]-FDG PET/CT imaging [18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CU PRS Administrator | Columbia University | 212-342-1643 | crchelp@columbia.edu |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
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| 1 month |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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. | The principal investigator has left the institution. Data will not be analyzed. Only the demographic information on 1 enrolled subject is available. | Posted | 1 month |
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| 0 |
| 0 |
| 0 |
| 0 |
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| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |