Hyperpolarized 13C-Pyruvate Imaging for Pancreatic Cysts

Overseen By Florencia McAllister, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: MRI contraindication, Cardiac arrhythmias, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

10 Participants Needed

Trial Summary

What is the purpose of this trial?

To learn if Hyperpolarized C-Pyruvate Magnetic Resonance (HP-MR) Spectroscopic Imaging can help doctors detect low-risk (benign) and high-risk (malignant) cysts.

Research Team

Florencia McAllister, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults who are planning to have surgery or a biopsy on their pancreatic cysts. They must be able to understand and sign consent forms, regardless of language. It's not for those with certain implants, pregnant or breastfeeding women, women not using birth control, individuals over 260 lbs, those with heart rhythm problems, MRI contraindications, Gadavist contrast allergy, or cognitive impairments.

Inclusion Criteria

I have a cyst in my pancreas.

I can participate regardless of my language.

Patients able to understand and willing to sign a written informed consent document

Exclusion Criteria

Contraindication to MRI

I have cognitive impairments.

Electrically, magnetically, or mechanically activated implants that would preclude MRI

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgical Imaging

Participants undergo Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging prior to surgical resection

4 weeks

1 visit (in-person)

Surgical Resection

Participants undergo surgical resection or cyst wall biopsy to obtain tissue samples for further analysis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgical resection

4 weeks

Treatment Details

Interventions

• Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging

Trial Overview The study tests if a special type of imaging called Hyperpolarized C-Pyruvate Magnetic Resonance Spectroscopic Imaging can distinguish between benign and malignant pancreatic cysts in patients scheduled for surgical removal of these cysts.

Participant Groups

Group I: Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+