Study Using Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging in Patients With Pancreatic Cysts Undergoing Surgical Resection

NCT05873699 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 2022-0854NCI-2023-04096
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pancreatic Cyst

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (1)

Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging

EXPERIMENTAL

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).

Drug: Hyperpolarized 13-C-pyruvate

Interventions

Hyperpolarized 13-C-pyruvate DRUG

Given by Injection

Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Pancreatic Cyst

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases

Study Officials

• Florencia McAllister, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florencia McAllister, MD

CONTACT

(713) 745-0914; fmcallister@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 24, 2023
• Study Start: August 18, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

US (1)