Hyperpolarized 13C‑pyruvate MRI to distinguish low‑risk and high‑risk pancreatic cysts
Pilot Study Using Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging in Patients With Pancreatic Cysts Undergoing Surgical Resection
This trial will test whether a special hyperpolarized 13C‑pyruvate MRI scan can help tell low‑risk from high‑risk pancreatic cysts in adults scheduled for surgical removal.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05873699 on ClinicalTrials.gov |
What this trial studies
Adults with pancreatic cysts who are scheduled for surgical resection or cyst wall biopsy will undergo a preoperative hyperpolarized 13C‑pyruvate MR spectroscopic imaging scan to measure metabolic conversion rates (kpl). After surgery, pathology will classify cysts as benign/low‑risk or malignant/high‑risk and those results will be compared with the imaging kpl values. Secondary analyses will explore a kpl threshold associated with high‑risk cysts and correlate in vivo HP‑MR findings with ex vivo tissue metabolomics and blood/cyst fluid biomarkers such as CA19‑9 and CEA. This Phase 1, single‑site feasibility study aims to define metabolic signatures and preliminary cutoff values for future validation.
Who should consider this trial
Good fit: Adults (≥18) with pancreatic cysts who are scheduled for surgical resection or cyst wall biopsy, can undergo MRI (no incompatible implants), can provide informed consent, are not pregnant or breastfeeding, and meet the site's weight limit are ideal candidates.
Not a fit: Patients who are not having surgery, cannot undergo MRI (due to implants, contrast allergy, or other contraindications), are pregnant or breastfeeding, are cognitively impaired, under 18, or exceed the weight limit are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this technique could offer a noninvasive way to distinguish benign from high‑risk pancreatic cysts before surgery, potentially avoiding unnecessary operations and improving treatment planning.
How similar studies have performed: Hyperpolarized 13C‑pyruvate MR has shown promising metabolic imaging results in other cancers (for example prostate and brain), but applying it to classify pancreatic cysts is novel and not yet validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Florencia McAllister, MD — M.D. Anderson Cancer Center
- Study coordinator: Florencia McAllister, MD
- Email: fmcallister@mdanderson.org
- Phone: (713) 745-0914
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.