Hyperpolarized C Pyruvate Magnetic Resonance Imaging, And Blood-Based Biomarkers For Early Detection Of Pancreatic Adenocarcinoma In Patients With Intraductal Papillary Mucinous Neoplasms

Study Overview

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)

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Pancreatic Cyst

DIAGNOSTIC_TEST: 89Zr-DFO-HuMab-5B1 immunoPET
DIAGNOSTIC_TEST: HP MRI
COMBINATION_PRODUCT: Blood assay

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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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-03-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-21
First Submitted that Met QC Criteria 2024-03-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-24
First Posted (ACTUAL) 2024-03-12	Results First Posted N/A	Last Verified 2025-04

Study Plan

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

Design Details

Primary Purpose:
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Allocation:
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Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	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. 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

Participant Group/Arm

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.

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

Primary Outcome Measures	Measure Description	Time Frame
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.	up to 1 year

Secondary Outcome Measures	Measure Description	Time Frame

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

Name: Kevin Soares, MD

Phone Number: 212-639-3195

Email: soaresk@mskcc.org

Study Contact Backup

Name: David Kelson, MD

Phone Number: 646-888-4179

Email: kelsend@MSKCC.ORG

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

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.

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Kevin Soares, MD, Memorial Sloan Kettering Cancer Center

Publications

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

General Publications

No publications available

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Clinical Trial Record