Clinical trial · Interventional
Study Using Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging in Patients With Pancreatic Cysts Undergoing Surgical Resection
Pilot Study Using Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging in Patients With Pancreatic Cysts Undergoing Surgical Resection
NCT05873699CI-TRIAL-00121975suspendedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI Request
Summary
Brief summary (as posted)
To learn if Hyperpolarized C-Pyruvate Magnetic Resonance (HP-MR) Spectroscopic Imaging can help doctors detect low-risk (benign) and high-risk (malignant) cysts.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperpolarized 13-C-pyruvate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging
- description
- Participants will have the HP-MR scan within the 4 weeks before your scheduled surgery. Hyperpolarized C-Pyruvate will be injected by vein during the scan. Your vital signs (temperature, blood pressure, heart rate and respiration \[breathing\]) will be monitored during the scan. The estimated time of the scan is a couple of minutes, but you may be in the room of the MRI for up to 30 minutes for preparation. The entire process of obtaining the MRI (and possible blood draw) may be up to half of a work day (not including your personal travel time).
- interventionNames
- Drug: Hyperpolarized 13-C-pyruvate
Primary outcomes (1)
- measure
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
- timeFrame
- Through study completion; an average of 1 year.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients ≥ 18 years old. Patients under 18 are excluded due to their potential inability to understand and consent independently to the methods required for the study drug use and its potential risks and benefits. * Patients with pancreatic cyst/s * Patients who will undergo surgical resection (or cyst wall biopsy) of pancreatic cysts * Patients able to understand and willing to sign a written informed consent document * Both English-speaking and non-English-speaking patients are eligible for participation Exclusion Criteria: * Contraindication to MRI * Electrically, magnetically, or mechanically activated implants that would preclude MRI * Allergy to Gadavist IV contrast * History of cardiac arrhythmias * Pregnancy or breastfeeding women * Women of child-bearing age that are sexually active and not using birth control * Cognitively impaired individuals * Weight above 260 pounds (lbs)
References
Publications (0)
Data not yet available
No reference posted for this study.