Clinical trial · Observational
Hyperpolarized C Pyruvate Magnetic Resonance Imaging, and Blood-Based Biomarkers for Early Detection of Pancreatic Adenocarcinoma in Patients With Intraductal Papillary Mucinous Neoplasms
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cyst | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 89Zr-DFO-HuMab-5B1 immunoPET | Diagnostic Test | — | UNRESOLVED |
| Blood assay | Combination Product | — | UNRESOLVED |
| HP MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- High Risk Pancreatic Cystic Neoplasm
- description
- Participants will be diagnosed with a pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection
- interventionNames
- Diagnostic Test: 89Zr-DFO-HuMab-5B1 immunoPET
- Diagnostic Test: HP MRI
- Combination Product: Blood assay
Primary outcomes (1)
- measure
- Sensitivity of ImmunoPET to identify presence or absence of adenocarcinoma
- timeFrame
- up to 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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