Detecting pancreatic cancer early using imaging and blood tests
Immuno-Positron Emission Tomography, Hyperpolarized C Pyruvate Magnetic Resonance Imaging, and Blood-Based Biomarkers for Early Detection of Pancreatic Adenocarcinoma in Patients With Intraductal Papillary Mucinous Neoplasms
This study is testing new imaging and blood tests to see if they can help find pancreatic cancer early in people who have high-risk pancreatic cysts.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | HuMab |
| Locations | 8 sites (Basking Ridge, New Jersey and 7 other locations) |
| Trial ID | NCT06305728 on ClinicalTrials.gov |
What this trial studies
This observational study aims to find effective methods for early detection of pancreatic ductal adenocarcinoma (PDAC) in patients with high-risk pancreatic cystic neoplasms. Researchers will utilize a combination of advanced imaging techniques, including ImmunoPET scans and hyperpolarized MRI, alongside blood-based biomarkers to identify signs of PDAC. The goal is to develop a non-invasive approach to detect cancer early, potentially avoiding the need for surgical intervention. Participants will undergo these imaging tests and blood assays to evaluate their effectiveness in early detection.
Who should consider this trial
Good fit: Ideal candidates are men and women over 18 years old with high-risk pancreatic cystic neoplasms requiring surgical resection.
Not a fit: Patients with existing pancreatic cancer or those unable to tolerate the required imaging procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis of pancreatic cancer, improving treatment outcomes and survival rates.
How similar studies have performed: Other studies have explored similar imaging and biomarker approaches for cancer detection, showing promising results, but this specific combination is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Basking Ridge, New Jersey and 7 other locations
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All protocol activites) — New York, New York, United States (Recruiting)
- Weill Cornell Medical Center (Specimen Analysis Only) — New York, New York, United States (Not_yet_recruiting)
- Memorial Sloan Kettering Nassau (Limited Protocol Activites) — Rockville Centre, New York, United States (Recruiting)
Study contacts
- Principal investigator: Kevin Soares, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Kevin Soares, MD
- Email: soaresk@mskcc.org
- Phone: 212-639-3195
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.