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Hyperpolarized C Pyruvate Magnetic Resonance Imaging, and Blood-Based Biomarkers for Early Detection of Pancreatic Adenocarcinoma in Patients With Intraductal Papillary Mucinous Neoplasms

Purpose

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: - The ImmunoPET scan (immune-positron emission tomography scan) with the imaging agent 89Zr-DFO-HuMab-5B1 - The HP MRI scan (hyperpolarized pyruvate magnetic resonance imaging scan)

Condition

Pancreatic Cyst

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Men and women aged >18 years - Pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection - Able to provide informed consent

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 1. Bilirubin > 1.5 x ULN 2. AST/ALT > 2.5 x ULN 3. Albumin < 3 g/dL 4. GGT > 2.5 x ULN if Alkaline Phosphatase > 2.5 x ULN - 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.

Study Design

Phase
Study Type: Observational
Observational Model: Cohort
Time Perspective: Prospective

Arm Groups

Arm	Description	Assigned Intervention
High Risk Pancreatic Cystic Neoplasm	Participants will be diagnosed with a pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection	Diagnostic Test: 89Zr-DFO-HuMab-5B1 immunoPET Participants who choose to will undergo immunoPET before surgery. Other names: immunoPET Diagnostic Test: HP MRI Participants who choose to will undergo HP MRI before surgery. Combination Product: Blood assay Will be drawn within 6 weeks of surgery and annually as post operative care Other names: CA19-.9

Recruiting Locations

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge 5095409, New Jersey 5101760 07920