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: NCT06305728
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
25 participants
OBSERVATIONAL
2024-03-04
2030-03-04
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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High Risk Pancreatic Cystic Neoplasm
Participants will be diagnosed with a pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection
89Zr-DFO-HuMab-5B1 immunoPET
Participants who choose to will undergo immunoPET before surgery.
HP MRI
Participants who choose to will undergo HP MRI before surgery.
Blood assay
Will be drawn within 6 weeks of surgery and annually as post operative care
Interventions
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89Zr-DFO-HuMab-5B1 immunoPET
Participants who choose to will undergo immunoPET before surgery.
HP MRI
Participants who choose to will undergo HP MRI before surgery.
Blood assay
Will be drawn within 6 weeks of surgery and annually as post operative care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection
* Able to provide informed consent
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Kevin Soares, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York, United States
Weill Cornell Medical Center (Specimen Analysis Only)
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Kevin Soares, MD
Role: primary
Kevin Soares, MD
Role: primary
Kevin Soares, MD
Role: primary
Kevin Soares, MD
Role: primary
Kevin Soares, MD
Role: primary
Kevin Soares, MD
Role: primary
David Lyden, MD
Role: primary
Kevin Soares, PhD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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23-367
Identifier Type: -
Identifier Source: org_study_id
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