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

RECRUITINGSponsored by Memorial Sloan Kettering Cancer Center
Actively Recruiting
SponsorMemorial Sloan Kettering Cancer Center
Started2024-03-04
Est. completion2030-03-04
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations8 sites

Summary

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

Age: 18 Years+Healthy volunteers accepted
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

  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.

Conditions2

CancerPancreatic Cyst

Locations8 sites

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Kevin Soares, MD212-639-3195
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748
Kevin Soares, MD212-639-3195
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Kevin Soares, MD212-639-3195
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, 11725
Kevin Soares, MD212-639-3195
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Kevin Soares, MD212-639-3195

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