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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06305728
Status
Recruiting

Conditions

  • Pancreatic Cyst

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 89Zr-DFO-HuMab-5B1 immunoPET — DIAGNOSTIC_TEST
    Participants who choose to will undergo immunoPET before surgery.
  • HP MRI — DIAGNOSTIC_TEST
    Participants who choose to will undergo HP MRI before surgery.
  • Blood assay — COMBINATION_PRODUCT
    Will be drawn within 6 weeks of surgery and annually as post operative care

Study Details

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)

Key Dates

Start date
Mar 4, 2024
Status verified
Oct 2025
Primary completion
Mar 4, 2030
Completion
Mar 4, 2030

Study Design

Enrollment
25 participants (estimated)

Arms

  • Arm: High Risk Pancreatic Cystic Neoplasm
    Participants will be diagnosed with a pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection

Primary Outcome Measure

Sensitivity of ImmunoPET to identify presence or absence of adenocarcinoma [ Time Frame: up to 1 year ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Kevin Soares, MD
212-639-3195
Memorial Sloan Kettering Monmouth (Limited protocol activities)MiddletownNew Jersey07748
Kevin Soares, MD
212-639-3195
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Kevin Soares, MD
212-639-3195
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)CommackNew York11725
Kevin Soares, MD
212-639-3195
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Kevin Soares, MD
212-639-3195
Memorial Sloan Kettering Cancer Center (All protocol activites)New YorkNew York10065
Kevin Soares, MD
212-639-3195
Weill Cornell Medical Center (Specimen Analysis Only)New YorkNew York10065
David Lyden, MD
212-746-6565
Memorial Sloan Kettering Nassau (Limited Protocol Activites)Rockville CentreNew York11553
Kevin Soares, PhD
212-639-3195

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