Hyperpolarized C Pyruvate Magnetic Resonance Imaging, and Blood-Based Biomarkers for Early Detection of Pancreatic Adenocarcinoma in Patients With Intraductal Papillary Mucinous Neoplasms
Immuno-Positron Emission Tomography, Hyperpolarized C Pyruvate Magnetic Resonance Imaging, and Blood-Based Biomarkers for Early Detection of Pancreatic Adenocarcinoma in Patients With Intraductal Papillary Mucinous Neoplasms
Memorial Sloan Kettering Cancer Center
25 participants
Mar 4, 2024
OBSERVATIONAL
Conditions
Summary
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)
Eligibility
Inclusion Criteria3
- Men and women aged \>18 years
- Pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection
- Able to provide informed consent
Exclusion Criteria11
- 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
- Bilirubin \> 1.5 x ULN
- AST/ALT \> 2.5 x ULN
- Albumin \< 3 g/dL
- 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.
Interventions
Participants who choose to will undergo immunoPET before surgery.
Participants who choose to will undergo HP MRI before surgery.
Will be drawn within 6 weeks of surgery and annually as post operative care
Locations(8)
View Full Details on ClinicalTrials.gov
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NCT06305728