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NCT Number: NCT06305728

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)

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

89Zr-DFO-HuMab-5B1 immunoPET

Diagnostic Test

Participants who choose to will undergo immunoPET before surgery.

Other names: immunoPET

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

Other names: CA19-.9

Primary outcomes

  1. Sensitivity of ImmunoPET to identify presence or absence of adenocarcinoma

    Time frame: up to 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

David Kelson, MD

CONTACT

[email protected]

646-888-4179

Kevin Soares, MD

CONTACT

[email protected]

212-639-3195

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Mar 12, 2024
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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