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_TESTParticipants who choose to will undergo immunoPET before surgery.
- HP MRI — DIAGNOSTIC_TESTParticipants who choose to will undergo HP MRI before surgery.
- Blood assay — COMBINATION_PRODUCTWill 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 NeoplasmParticipants 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
- Kevin Soares, MD212-639-3195
- David Kelson, MD646-888-4179
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) | Basking Ridge | New Jersey | 07920 | Kevin Soares, MD 212-639-3195 |
| Memorial Sloan Kettering Monmouth (Limited protocol activities) | Middletown | New Jersey | 07748 | Kevin Soares, MD 212-639-3195 |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale | New Jersey | 07645 | Kevin Soares, MD 212-639-3195 |
| Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) | Commack | New York | 11725 | Kevin Soares, MD 212-639-3195 |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Harrison | New York | 10604 | Kevin Soares, MD 212-639-3195 |
| Memorial Sloan Kettering Cancer Center (All protocol activites) | New York | New York | 10065 | Kevin Soares, MD 212-639-3195 |
| Weill Cornell Medical Center (Specimen Analysis Only) | New York | New York | 10065 | David Lyden, MD 212-746-6565 |
| Memorial Sloan Kettering Nassau (Limited Protocol Activites) | Rockville Centre | New York | 11553 | Kevin Soares, PhD 212-639-3195 |
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