Hyperpolarized C Pyruvate Magnetic Resonance Imaging, and Blood-Based Biomarkers for Early Detection of Pancreatic Adenocarcinoma in Patients With Intraductal Papillary Mucinous Neoplasms
Recruiting · NCT06305728 · Observational (researchers observe without assigning treatment) · Lead sponsor: Memorial Sloan Kettering Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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)
Who can take part
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.
Where it is running
8 locations listed across 2 US states.
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) - Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Monmouth (Limited protocol activities) - Middletown, New Jersey, United States
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale, New Jersey, United States
- Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) - Commack, New York, United States
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison, New York, United States
- Memorial Sloan Kettering Cancer Center (All protocol activites) - New York, New York, United States
- Weill Cornell Medical Center (Specimen Analysis Only) - New York, New York, United States
- Memorial Sloan Kettering Nassau (Limited Protocol Activites) - Rockville Centre, New York, United States