Pancreatic Cyst
Conditions
Keywords
Pancreatic Cyst, Memorial Sloan Kettering Cancer Center, 23-367
Brief 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)
Interventions
DIAGNOSTIC_TEST89Zr-DFO-HuMab-5B1 immunoPET
Participants who choose to will undergo immunoPET before surgery.
DIAGNOSTIC_TESTHP MRI
Participants who choose to will undergo HP MRI before surgery.
COMBINATION_PRODUCTBlood assay
Will be drawn within 6 weeks of surgery and annually as post operative care
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of ImmunoPET to identify presence or absence of adenocarcinoma | up to 1 year | Assess preliminary sensitivity and specificity if the immunoPET is able to identify the presence or absence of adenocarcinoma or high-grade dysplasia in participants who are scheduled to undergo surgical resection. |
Countries
United States
Contacts
CONTACTKevin Soares, MD
CONTACTDavid Kelson, MD
PRINCIPAL_INVESTIGATORKevin Soares, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed