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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
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
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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