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

October 8, 2025 updated by: Memorial Sloan Kettering Cancer Center

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
        • Contact:
          • Kevin Soares, MD
          • Phone Number: 212-639-3195
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (Limited protocol activities)
        • Contact:
          • Kevin Soares, MD
          • Phone Number: 212-639-3195
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (Limited protocol activities)
        • Contact:
          • Kevin Soares, MD
          • Phone Number: 212-639-3195
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
        • Contact:
          • Kevin Soares, MD
          • Phone Number: 212-639-3195
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (Limited protocol activities)
        • Contact:
          • Kevin Soares, MD
          • Phone Number: 212-639-3195
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activites)
        • Contact:
          • Kevin Soares, MD
          • Phone Number: 212-639-3195
      • New York, New York, United States, 10065
        • Not yet recruiting
        • Weill Cornell Medical Center (Specimen Analysis Only)
        • Contact:
          • David Lyden, MD
          • Phone Number: 212-746-6565
      • Rockville Centre, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (Limited protocol activites)
        • Contact:
          • Kevin Soares, PhD
          • Phone Number: 212-639-3195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of ImmunoPET to identify presence or absence of adenocarcinoma
Time Frame: up to 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Kevin Soares, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2024

Primary Completion (Estimated)

March 4, 2030

Study Completion (Estimated)

March 4, 2030

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

March 5, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Estimated)

October 9, 2025

Last Update Submitted That Met QC Criteria

October 8, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-367

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

• 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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