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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
Conditions: Pancreatic Cyst
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 25
Sponsor: Memorial Sloan Kettering Cancer Center
Location: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) Basking Ridge New Jersey
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 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
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.
Source: ClinicalTrials.gov (NCT06305728). StuddyBuddy aggregates publicly available trial information.