Imaging metabolic processes in the body using Carbon-13 pyruvate
Hyperpolarized MR Imaging with Carbon-13 Pyruvate in the Human Body
This study is testing a new type of MRI using a special substance to see if it can help us understand how the body processes energy in people with heart problems and healthy volunteers without using harmful radiation.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 21 Years to 99 Years |
| Sex | All |
| Sponsor | National Heart Centre Singapore Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06645691 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of hyperpolarized Carbon-13 magnetic resonance imaging (MRI) to assess metabolic processes in patients with cardiovascular and cardiometabolic diseases, as well as healthy volunteers. The approach aims to improve upon conventional imaging techniques by providing insights into downstream metabolism without the exposure to ionizing radiation associated with other imaging methods. Participants will receive hyperpolarized 13C-pyruvate to enhance MRI signals, allowing for a more detailed understanding of tissue metabolism. The study will evaluate the feasibility of this innovative imaging technique in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates include adults aged 21 and older with cardiovascular or cardiometabolic diseases, as well as healthy volunteers without significant medical co-morbidities.
Not a fit: Patients with significant medical co-morbidities or contraindications for MRI procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could provide a non-invasive method for better diagnosing and monitoring treatment responses in various diseases.
How similar studies have performed: While the use of hyperpolarized 13C imaging has been demonstrated in various settings, this specific application in a clinical context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Healthy Volunteers: 1. Age 21 years and above 2. No significant medical co-morbidities (such as chronic kidney disease, diabetes mellitus, heart failure, ischemic heart disease, previous strokes) 3. No history of cancer 4. Able and willing to comply with study procedures and provide signed informed consent Patients with cardiovascular/cardiometabolic diseases: 1. Age 21 years and above 2. Physician diagnosed cardiovascular conditions: ischemic heart disease, inherited cardiomyopathies (hypertrophic, dilated or infiltrative cardiomyopathies) and stable heart failure; and/or 3. Cardiometabolic conditions (such as diabetes on medications, hypertension, central obesity, fatty liver disease) 4. Able and willing to comply with study procedures and provide signed informed consent Exclusion Criteria: 1. Standard contraindications for magnetic resonance procedures (such as implantable medical devices, suspected presence of surgical apparatus or shrapnel, severe claustrophobia) 2. Unstable medical conditions (such as symptomatic heart failure, unstable hypertension/glucose levels as determined by investigators, symptomatic arrhythmias, angina) 3. Pregnant or nursing women 4. Known allergies to pyruvate or any of its components
Where this trial is running
Singapore
- National Heart Centre Singapore — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: Calvin WL Chin
- Email: CAMI@nhcs.com.sg
- Phone: 6568449055
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.