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

Description

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)

Conditions

Pancreatic Cyst

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Study Overview

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Study Details

Study 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)

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

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

Condition
Pancreatic Cyst
Intervention / Treatment

-

Contacts and Locations

Basking Ridge

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States, 07920

Middletown

Memorial Sloan Kettering Monmouth (Limited protocol activities), Middletown, New Jersey, United States, 07748

Montvale

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States, 07645

Commack

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity), Commack, New York, United States, 11725

Harrison

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York, United States, 10604

New York

Memorial Sloan Kettering Cancer Center (All protocol activites), New York, New York, United States, 10065

New York

Weill Cornell Medical Center (Specimen Analysis Only), New York, New York, United States, 10065

Rockville Centre

Memorial Sloan Kettering Nassau (Limited Protocol Activites), Rockville Centre, New York, United States, 11553

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Men and women aged \>18 years
  • * Pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection
  • * Able to provide informed consent
  • * 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
  • 1. Bilirubin \> 1.5 x ULN
  • 2. AST/ALT \> 2.5 x ULN
  • 3. Albumin \< 3 g/dL
  • 4. 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

Kevin Soares, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

2030-03-04