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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 99
Healthy Volunteers: t
View:

⁃ Healthy Volunteers:

• Age 21 years and above

• No significant medical co-morbidities (such as chronic kidney disease, diabetes mellitus, heart failure, ischemic heart disease, previous strokes)

• No history of cancer

• Able and willing to comply with study procedures and provide signed informed consent

⁃ Patients with cardiovascular/cardiometabolic diseases:

• Age 21 years and above

• Physician diagnosed cardiovascular conditions: ischemic heart disease, inherited cardiomyopathies (hypertrophic, dilated or infiltrative cardiomyopathies) and stable heart failure; and/or

• Cardiometabolic conditions (such as diabetes on medications, hypertension, central obesity, fatty liver disease)

• Able and willing to comply with study procedures and provide signed informed consent

Locations
Other Locations
Singapore
National Heart Centre Singapore
RECRUITING
Singapore
Contact Information
Primary
Calvin WL Chin
CAMI@nhcs.com.sg
6568449055
Time Frame
Start Date: 2024-10-17
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 200
Treatments
Experimental: Hyperpolarized Pyruvate [13C] Injection
Hyperpolarized 13C-pyruvate is injected intravenously at a dose of 0.43 mL/kg body weight, and at a rate of 5 mL/second followed by a 20 mL saline flush at 5 mL/second when the patient is already in the MRI scanner.
Related Therapeutic Areas
Sponsors
Leads: National Heart Centre Singapore
Collaborators: National Medical Research Council (NMRC), Singapore

This content was sourced from clinicaltrials.gov

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