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

Recruiting

• Conditions: Pancreatic Cyst
• Interventions: Diagnostic Test: 89Zr-DFO-HuMab-5B1 immunoPET; Diagnostic Test: HP MRI; Combination Product: Blood assay

• Registration Number: NCT06305728
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-04
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-05
• Study First Posted: 2024-03-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24
• Primary Completion: 2030-03-04
• Study Completion: 2030-03-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High Risk Pancreatic Cystic Neoplasm	Blood assay	Participants will be diagnosed with a pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection
High Risk Pancreatic Cystic Neoplasm	89Zr-DFO-HuMab-5B1 immunoPET	Participants will be diagnosed with a pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection
High Risk Pancreatic Cystic Neoplasm	HP MRI	Participants will be diagnosed with a pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (8)

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