Actively Recruiting

Phase 2
Age: 21Years - 99Years
All Genders
Healthy Volunteers
ID06645691

Hyperpolarized MR Imaging with Carbon-13 Pyruvate for Heart and Cardiometabolic Diseases in Adults

Led by National Heart Centre Singapore · Updated on 2024-12-06

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

N

National Heart Centre Singapore

Lead Sponsor

N

National Medical Research Council (NMRC), Singapore

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are exploring a new imaging technique called carbon-13 (13C) magnetic resonance imaging (MRI) to better understand metabolism in the body. Unlike the usual PET scans with 18F fluorodeoxyglucose (FDG), which show glucose uptake but not metabolic changes down the line, this method uses hyperpolarized 13C-pyruvate to enhance MRI signals dramatically. The study aims to assess the feasibility and usefulness of this approach in healthy volunteers and patients with cardiovascular or cardiometabolic diseases. In this study, participants will receive an intravenous injection of hyperpolarized 13C-pyruvate at a dose of 0.43 mL per kilogram of body weight. The injection is given at a rate of 5 mL per second, followed by a saline flush, all while inside an MRI scanner. This procedure is designed to capture rapid metabolic processes by acquiring high-quality images within a short time frame because the enhanced signal from hyperpolarization lasts only 1 to 2 minutes. The study will establish reference ranges for metabolic products in healthy volunteers and develop applications for patients with heart and metabolic diseases. Participants will be involved in imaging sessions lasting about 30 to 45 minutes after the injection to assess the reproducibility and feasibility of the imaging technique. Researchers will monitor metabolic activity through the MRI scans and analyze outcomes related to the imaging process itself. The study includes healthy volunteers and patients with diagnosed cardiovascular or cardiometabolic conditions. Safety will be monitored throughout, and participants will be asked to comply with study procedures and provide informed consent. The total duration for participation depends on individual scheduling but centers around the imaging session and follow-up for data collection.

CONDITIONS

Brief Title

Hyperpolarized MR Imaging with Carbon-13 Pyruvate in the Human Body

Who Can Participate

Age: 21Years - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 21 years and above
  • Healthy volunteers with no significant medical co-morbidities such as chronic kidney disease, diabetes mellitus, heart failure, ischemic heart disease, or previous strokes
  • No history of cancer
  • Physician diagnosed cardiovascular conditions including ischemic heart disease, inherited cardiomyopathies (hypertrophic, dilated or infiltrative), and stable heart failure; and/or cardiometabolic conditions such as diabetes on medications, hypertension, central obesity, or fatty liver disease
  • Able and willing to comply with study procedures and provide signed informed consent
Not Eligible

You will not qualify if you...

  • Standard contraindications for magnetic resonance procedures such as implantable medical devices, suspected surgical apparatus or shrapnel, or severe claustrophobia
  • Unstable medical conditions including symptomatic heart failure, unstable hypertension or glucose levels, symptomatic arrhythmias, or angina
  • Pregnant or nursing women
  • Known allergies to pyruvate or any of its components

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment session

Participants receive an injection of hyperpolarized 13C-pyruvate while in the MRI scanner to undergo metabolic imaging.

1 visit (in-person)

Follow-up

Duration - Approximately 30 to 45 minutes post dose

Participants are monitored for approximately 30 to 45 minutes after the injection to assess the feasibility and reproducibility of the imaging technique.

1 visit (in-person, immediately after treatment)

Trial Site Locations

Total: 1 location

1

National Heart Centre Singapore

Singapore, Singapore, 169609

Actively Recruiting

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Research Team

C

Calvin WL Chin

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Frequently Asked Questions

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