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The purpose of this study is for researchers to find ways of detecting pancreatic ductal adenocarcinoma/PDAC early to avoid the invasive procedure of surgery. The study researchers think a combination of imaging and a series of blood tests may be an effective way to detect PDAC early. In this study, researchers will look at whether a combination of the following types of imaging with blood tests can detect PDAC in pancreatic cysts:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Risk Pancreatic Cystic Neoplasm | Participants will be diagnosed with a pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 89Zr-DFO-HuMab-5B1 immunoPET | Diagnostic Test | Participants who choose to will undergo immunoPET before surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of ImmunoPET to identify presence or absence of adenocarcinoma | Assess preliminary sensitivity and specificity if the immunoPET is able to identify the presence or absence of adenocarcinoma or high-grade dysplasia in participants who are scheduled to undergo surgical resection. | up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Pathologic evidence of pancreatic cancer
Pregnant or breast-feeding patients
Refusal or inability to tolerate scan (eg anxiety or claustrophobia)
Inability to lay flat or meet the standard requirements of traditional MRI
Hepatic function from assays obtained within 6 weeks prior to the study enrollment. For each patient, the upper limit of normal (ULN) value for a particular assay will be defined by the normal reference values of the laboratory that performed the assay
Renal function with Creatinine > 1.5 x ULN or creatinine clearance < 60 mL/min, from assays obtained within 6 weeks prior to study enrollment
Cardiac: congestive heart failure with New York Heart Association (NYHA) status ≥2, poorly controlled hypertension, a history of clinically significant EKG abnormalities, or myocardial infarction within 6 months of study enrollment.
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Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan Kettering (MSK).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kevin Soares, MD | Contact | 212-639-3195 | soaresk@mskcc.org | |
| David Kelson, MD | Contact | 646-888-4179 | kelsend@MSKCC.ORG |
| Name | Affiliation | Role |
|---|---|---|
| Kevin Soares, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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• Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| HP MRI | Diagnostic Test | Participants who choose to will undergo HP MRI before surgery. |
|
| Blood assay | Combination Product | Will be drawn within 6 weeks of surgery and annually as post operative care |
|
|
| Memorial Sloan Kettering Monmouth (Limited protocol activities) | Recruiting | Middletown | New Jersey | 07748 | United States |
|
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Recruiting | Montvale | New Jersey | 07645 | United States |
|
| Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) | Recruiting | Commack | New York | 11725 | United States |
|
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Recruiting | Harrison | New York | 10604 | United States |
|
| Memorial Sloan Kettering Cancer Center (All protocol activites) | Recruiting | New York | New York | 10065 | United States |
|
| Weill Cornell Medical Center (Specimen Analysis Only) | Not yet recruiting | New York | New York | 10065 | United States |
|
| Memorial Sloan Kettering Nassau (Limited Protocol Activites) | Recruiting | Rockville Centre | New York | 11553 | United States |
|
| ID | Term |
|---|---|
| D010181 | Pancreatic Cyst |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D018395 | CA-19-9 Antigen |
| ID | Term |
|---|---|
| D015295 | Antigens, Tumor-Associated, Carbohydrate |
| D000951 | Antigens, Neoplasm |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D007983 | Lewis Blood Group Antigens |
| D001789 | Blood Group Antigens |
| D000954 | Antigens, Surface |
| D000939 | Epitopes |
| D007519 | Isoantigens |
| D014408 | Biomarkers, Tumor |
| D015415 | Biomarkers |
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