NCT06645691 Hyperpolarized MR Imaging with Carbon-13 Pyruvate in the Human Body
| NCT ID | NCT06645691 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | National Heart Centre Singapore |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-10-17 |
| Primary Completion | 2028-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2024-10-17 with a primary completion date of 2028-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Positron emission tomography with 18F fluorodeoxyglucose (FDG) is the conventional imaging technique to provide information regarding tissue glucose uptake and has been highly clinically successful. However, it cannot assess downstream metabolism, which may be useful in the diagnosis and assessment of treatment response in a variety of diseases. Patients will also be exposed to ionizing radiation, the amount of exposure can vary depending on the dose of tracer administered, frequency of scans and duration of each scan. Carbon-13 (13C) magnetic resonance imaging (MRI) is particularly attractive for metabolic imaging because carbon serves as the backbone of nearly all organic molecules in the body. With this technique, the polarization increases to approximately 30%-40%, an increase of over 10,000 to 100,000-fold, thereby dramatically increasing the MRI signal . Whilst the role of 13C imaging has been demonstrated in many sites around the world, we aim to demonstrate the feasibility and application of 13C hyperpolarized imaging in healthy Singapore residents and patients with cardiovascular and/or cardiometabolic diseases.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06645691 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 99 Years, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06645691 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06645691 currently recruiting?
Yes, NCT06645691 is actively recruiting participants. Contact the research team at CAMI@nhcs.com.sg for enrollment information.
Where is the NCT06645691 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT06645691 clinical trial?
NCT06645691 is sponsored by National Heart Centre Singapore. The trial plans to enroll 200 participants.
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