Actively Recruiting
Immuno-Positron Emission Tomography and Hyperpolarized C Pyruvate MRI with Blood Biomarkers for Early Detection of Pancreatic Adenocarcinoma in High-Risk Pancreatic Cystic Neoplasms
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-10-09
25
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying ways to detect pancreatic ductal adenocarcinoma (PDAC) early in patients with pancreatic cysts to avoid invasive surgery. They believe that combining special imaging techniques with blood tests may help identify PDAC at an early stage. This observational study focuses on patients with high-risk pancreatic cystic neoplasms who require surgical removal. Participants may undergo an ImmunoPET scan using the imaging agent 89Zr-DFO-HuMab-5B1 and a hyperpolarized pyruvate magnetic resonance imaging (HP MRI) scan before surgery. Blood samples will be collected within six weeks before surgery and then annually after surgery as part of post-operative care. These tests are being evaluated to find the best combination for detecting PDAC early. During the study, participants will have imaging scans and blood tests to monitor their pancreatic cysts. Researchers will assess the sensitivity of the ImmunoPET scan to detect the presence or absence of adenocarcinoma over one year. The study includes monitoring of liver, kidney, and heart functions to ensure participant safety. The total duration and follow-up depend on the participant's surgery and post-operative care schedule.
CONDITIONS
Brief Title
Hyperpolarized C Pyruvate Magnetic Resonance Imaging, and Blood-Based Biomarkers for Early Detection of Pancreatic Adenocarcinoma in Patients With Intraductal Papillary Mucinous Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged over 18 years
- Diagnosed with a pancreatic cystic neoplasm considered high risk and requiring surgical removal
- Able to provide informed consent
You will not qualify if you...
- Pathologic evidence of pancreatic cancer
- Pregnant or breastfeeding patients
- Unable or unwilling to tolerate scans due to anxiety or claustrophobia
- Unable to lie flat or meet standard MRI requirements
- Liver function tests outside normal limits within 6 weeks before enrollment (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)
- Kidney function impaired with Creatinine > 1.5 x ULN or creatinine clearance less than 60 mL/min within 6 weeks before enrollment
- Heart conditions including congestive heart failure with NYHA class 2 or higher, poorly controlled hypertension, recent significant EKG abnormalities, or heart attack within 6 months before enrollment
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks before surgery
Participants who choose to will undergo immunoPET and HP MRI scans before surgery to detect pancreatic adenocarcinoma.
1 to 2 visits depending on participant choice
Duration - Day of surgery
Participants undergo surgical removal of the high-risk pancreatic cystic neoplasm.
1 in-person visit for surgery
Duration - Up to 1 year post surgery
Participants have blood assays drawn within 6 weeks of surgery and annually as part of post-operative care.
1 visit within 6 weeks after surgery and annual visits thereafter
Trial Site Locations
Total: 8 locations
1
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York, United States, 10065
Actively Recruiting
7
Weill Cornell Medical Center (Specimen Analysis Only)
New York, New York, United States, 10065
Not Yet Recruiting
8
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
K
Kevin Soares, MD
D
David Kelson, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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