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
1 other identifier
observational
25
1 country
8
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2024
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 4, 2024
CompletedFirst Submitted
Initial submission to the registry
March 5, 2024
CompletedFirst Posted
Study publicly available on registry
March 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 4, 2030
October 9, 2025
October 1, 2025
6 years
March 5, 2024
October 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
High Risk Pancreatic Cystic Neoplasm
Participants will be diagnosed with a pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection
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
Eligibility Criteria
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).
You may qualify if:
- Men and women aged \>18 years
- Pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection
- Able to provide informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin Soares, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2024
First Posted
March 12, 2024
Study Start
March 4, 2024
Primary Completion (Estimated)
March 4, 2030
Study Completion (Estimated)
March 4, 2030
Last Updated
October 9, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
• 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.