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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging method to help doctors distinguish between harmless and dangerous pancreatic cysts. The imaging uses hyperpolarized C-Pyruvate, a special substance injected during an MRI scan to provide clearer pictures of the cysts. It targets individuals with pancreatic cysts who plan to undergo surgery or a biopsy. Participants must understand and sign a consent form and have no conditions that prevent safe MRI use. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative imaging method.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging is safe?

Research shows that a new imaging technique, hyperpolarized 13C-pyruvate MRI, is being tested for safety and effectiveness in detecting pancreatic cysts. In earlier studies, patients generally handled the procedure well, and no serious side effects occurred.

The process involves injecting a special substance, 13C-pyruvate, into a vein and then using an MRI machine to take pictures. This method is noninvasive, meaning it doesn't require surgery. Researchers closely monitor patients during the procedure to ensure their safety.

As a phase 1 study, the main goal is to assess safety and determine the right dose. If a treatment successfully passes this stage, it is usually considered safe enough for further testing. However, because this is an early phase, all safety details are not yet fully understood. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about hyperpolarized 13C-pyruvate magnetic resonance spectroscopic imaging because it offers a brand-new way to visualize pancreatic cysts. Unlike traditional imaging techniques, this method uses hyperpolarized 13C-pyruvate as a contrast agent to provide incredibly detailed images, potentially allowing doctors to better assess the nature of these cysts. This innovative approach could lead to more accurate diagnoses and improved treatment plans without the need for invasive procedures. Plus, the imaging process is quick, taking just a few minutes, which is a significant advantage over some existing diagnostic methods.

What evidence suggests that Hyperpolarized 13C-Pyruvate Imaging is effective for detecting pancreatic cysts?

Research has shown that a special imaging technique called Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging (HP-MR), which participants in this trial will undergo, might help doctors determine if pancreatic cysts are non-cancerous or cancerous. This technique examines how pyruvate, a natural substance in the body, is used in tissues. Studies have found that cancerous cells often convert pyruvate into another substance called lactate more than normal cells do. By highlighting these changes, HP-MR could provide clearer information about the cysts. Early evidence suggests this method might offer a noninvasive way to assist with diagnosis and treatment decisions. ^{1 2 5 6 7}

Who Is on the Research Team?

Florencia McAllister, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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

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

Weight above 260 pounds (lbs)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05873699

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

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-04096

13C-Pyruvate Magnetic Resonance Spectroscopic Imaging ... Using hyperppolarized 13C-pyruvate MRI (HP MR) may improve detection of malignant pancreatic cysts undergoing surgical resection. Eligibility Criteria ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10224418/

Enhancing Cancer Diagnosis with Real-Time Feedback This review article discusses the potential of hyperpolarized (HP) 13 C magnetic resonance spectroscopic imaging (MRSI) as a noninvasive technique for ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38041836/

Hyperpolarized 13C Metabolic MRI of Patients with Pancreatic ... Data conclusion: Altered pyruvate metabolism with increased lactate or reduced alanine was observed in the primary tumor. Early metabolic ...

5. digitalcommons.library.tmc.edu digitalcommons.library.tmc.edu/cgi/viewcontent.cgi?article=1293&context=uthgsbs_docs

Tumor Metabolism through Hyperpolarized 1-13C Pyruvate ... HP 13C metabolic imaging has the potential to offer a noninvasive readout of underlying tumor genomes and support tumor diagnosis and/or ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11120300/

MRI Application and Challenges of Hyperpolarized Carbon-13 ... Hyperpolarized magnetic resonance spectroscopy and imaging is a technique that could assess the role of different aspects of metabolism in heart disease.

7. dctd.cancer.gov dctd.cancer.gov/drug-discovery-development/reagents-materials/imaging-ind-resources/documentation/13c-pyruvate-ib.pdf

Hyperpolarized Pyruvate (13C) Injection accelerated 8-channel hyperpolarized carbon-13 in vivo magnetic resonance Spectroscopic imaging. (MRSI). Journal of Magnetic Resonance Imaging : JMRI. 2013 ...