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NCT06305728Recruiting

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

Start Date

3/4/2024

Completion Date

3/4/2030

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DIAGNOSTIC_TEST

89Zr-DFO-HuMab-5B1 immunoPET

DIAGNOSTIC_TEST

HP MRI

COMBINATION_PRODUCT

Blood assay

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Conditions

Pancreatic Cyst

Locations

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey 07920

United States

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey 07645

United States

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

Commack, New York 11725

United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York 10604

United States

Memorial Sloan Kettering Cancer Center (All protocol activites)

New York, New York 10065

United States

Weill Cornell Medical Center (Specimen Analysis Only)

New York, New York 10065

United States

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York 11553

United States