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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women aged >18 years

Pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection

Able to provide informed consent

Disqualifiers

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

Trial population

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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: High Risk Pancreatic Cystic Neoplasm3 interventions

Trial outcomes

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.

Time frame
up to 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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