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Hyperpolarized 13C-Pyruvate Imaging for Pancreatic Cysts

Phase 1

Recruiting

Led By Florencia McAllister, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

Study Summary

This trial tests if HP-MR can spot benign and malignant cysts, helping docs make more accurate diagnoses.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include reactions related to the MRI procedure or the Gadavist IV contrast used during imaging. These could range from mild discomfort at the injection site to more serious allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic ImagingExperimental Treatment1 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).

Do I qualify?Apply below to find out

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Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,466 Total Patients Enrolled

1 Trials studying Pancreatic Cyst

10 Patients Enrolled for Pancreatic Cyst

Florencia McAllister, MDPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

10 Total Patients Enrolled

Media Library

Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging Clinical Trial Eligibility Overview. Trial Name: NCT05873699 — Phase 1

Pancreatic Cyst Research Study Groups: Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging

Pancreatic Cyst Clinical Trial 2023: Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging Highlights & Side Effects. Trial Name: NCT05873699 — Phase 1

Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT05873699 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently openings for participants in this experiment?

"The trial, which was initially published on August 18th 2023, is still actively recruiting patients according to the information shared by clinicaltrials.gov. The details were last updated on the same day of its initial publication."

Answered by AI

Does the usage of Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging put individuals at risk?

"Our team at Power gave Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging a score of 1 on the safety scale due to its Phase 1 status, which demonstrates limited evidence for both efficacy and risk."

Answered by AI

To what extent has participation been achieved in this research endeavor?

"Correct. Per the information stored on clinicaltrials.gov, this medical study is recruiting participants at present time; it was first advertised on August 18th 2023 and recently revised on that same day. 10 patients are sought from a single trial site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Study Using Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging in Patients With Pancreatic Cysts Undergoing Surgical Resection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05873699.