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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Pancreatic Cyst

Treatments: Combination Product: Blood assay; Diagnostic Test: HP MRI; Diagnostic Test: 89Zr-DFO-HuMab-5B1 immunoPET

Study type: Observational

Funder types: Other

Identifiers

NCT06305728

23-367

Details and patient eligibility

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)

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

25 participants in 1 patient group

High Risk Pancreatic Cystic Neoplasm

Description:

Participants will be diagnosed with a pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection

Treatment:

Diagnostic Test: 89Zr-DFO-HuMab-5B1 immunoPET

Diagnostic Test: HP MRI

Combination Product: Blood assay