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Recruiting NCT06305728

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

— Observational Pancreatic Cyst

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 89Zr-DFO-HuMab-5B1 immunoPET, HP MRI, Blood assay.
Who it may be relevant to
Registry conditions: Pancreatic Cyst. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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)

Interventions

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

Primary outcome measures

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 8 centers
  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
  • Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) — Commack
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center (All protocol activites) — New York
  • Weill Cornell Medical Center (Specimen Analysis Only) — New York
  • Memorial Sloan Kettering Nassau (Limited Protocol Activites) — Rockville Centre

Identifiers

NCT: NCT06305728 · 23-367

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗