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RecruitingObservational

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

NCT ID: NCT06305728Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2025-10-09

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)

Arms & interventions

  • Diagnostic Test89Zr-DFO-HuMab-5B1 immunoPET

    Participants who choose to will undergo immunoPET before surgery.

  • Diagnostic TestHP MRI

    Participants who choose to will undergo HP MRI before surgery.

  • Combination ProductBlood assay

    Will be drawn within 6 weeks of surgery and annually as post operative care

Outcome measures

Primary

  • 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.

    Time frame: up to 1 year

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 locations (8)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

Recruiting
Kevin Soares, MD · Contact

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, 07748

Recruiting
Kevin Soares, MD · Contact

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

Recruiting
Kevin Soares, MD · Contact

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

Commack, New York, 11725

Recruiting
Kevin Soares, MD · Contact

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604

Recruiting
Kevin Soares, MD · Contact

Memorial Sloan Kettering Cancer Center (All protocol activites)

New York, New York, 10065

Recruiting
Kevin Soares, MD · Contact

Weill Cornell Medical Center (Specimen Analysis Only)

New York, New York, 10065

Not Yet Recruiting
David Lyden, MD · Contact

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, 11553

Recruiting
Kevin Soares, PhD · Contact
Hyperpolarized C Pyruvate Magnetic Resonance Imaging, and Blood-Based Biomarkers for Early Detection of Pancreatic Adenocarcinoma in Patients With Intraductal Papillary Mucinous Neoplasms | Cancerify