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Trial Title:
Hyperpolarized MR Imaging with Carbon-13 Pyruvate in the Human Body
NCT ID:
NCT06645691
Condition:
Heart Failure
Cardiometabolic Syndrome
Cancer Diagnosis
Cardiovascular Diseases
Healthy Volunteers
Conditions: Official terms:
Cardiovascular Diseases
Metabolic Syndrome
Conditions: Keywords:
Carbon-13 Pyruvate
Magnetic Resonance Imaging
Lactate
Alanine
Bicarbonate
Hyperpolarized Pyruvate (13C) Injection
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
This is a cross-sectional study conducted in healthy volunteers and patients with
cardiovascular/cardiometabolic diseases.
Hyperpolarized 13C-pyruvate will be injected intravenously to participants and the
metabolized products will be imaged in real time using MRI scanner. The goal is to
determine normal values of glucose metabolism in healthy volunteers and study the
potential applications of hyperpolarized imaging in patients with
cardiovascular/cardiometabolic diseases.
All patients will be invited to participate in a repeat scan with the same imaging
protocol.
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Hyperpolarized 13C-pyruvate
Description:
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
Arm group label:
Hyperpolarized Pyruvate [13C] Injection
Other name:
(13C) pyruvate
Other name:
Hyperpolarized Carbon C 13 Pyruvate
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.
Detailed description:
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. However, the low natural abundance of the 13C isotope at ~1.1% has made in vivo
imaging extremely challenging. To improve the MR signal 13C nuclei, probes are
synthetically enriched to increase the concentration of the 13C label in a molecule. MRI
signal can be further increased by the process of hyperpolarization. At low temperature
and high magnetic field, electrons have a very high level of polarization (ie, nearly all
the electrons are aligned in the same direction). This high level of polarization can be
transferred to 13C-labeled probes, increasing their MRI signals. This transfer of
polarization is accomplished by mixing radicals (a source of free electrons) with the
13C-labeled probe(s) to be hyperpolarized and placing the mixture in a polarizer at a
magnetic field typically of 3.0-5.0 T and at a low temperature (approximately 1 K).
Microwave irradiation is then applied to transfer the polarization from unpaired
electrons in a trityl radical to the 13C-labeled probe. The final solution retains a high
level of polarization and can be formulated to be at physiologic pH, osmolarity, and
temperature for in vivo injection and metabolic investigations.
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 (Figure 1).
The enhanced signal, however, is typically available only for a short period of time (1-2
minutes), as the polarization decays back to its thermal equilibrium level. Therefore,
rapid imaging is needed to acquire high signal-to-noise ratio metabolic data with minimal
polarization loss and to measure fast metabolic processes.
To date, hyperpolarized imaging technique has been performed in more than 800 healthy
volunteers and patients; and in more than 1,200 studies in various clinical conditions.
HYPOTHESIS AND OBJECTIVES:
This proof-of-concept study to demonstrate feasibility and application of 13C
hyperpolarized imaging in healthy Singapore residents and patients with
cardiovascular/cardiometabolic diseases.
1. To establish reference ranges in the metabolic products of hyperpolarized
13C-pyruvate (lactate, alanine and bicarbonate) in healthy volunteers and examine
repeatability of the 13C hyperpolarized imaging sequences.
2. To develop the application of 13C hyperpolarized imaging in patients with
cardiovascular and cardiometabolic diseases.
Criteria for 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
Gender:
All
Minimum age:
21 Years
Maximum age:
99 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
National Heart Centre Singapore
Address:
City:
Singapore
Zip:
169609
Country:
Singapore
Status:
Recruiting
Start date:
October 17, 2024
Completion date:
May 31, 2028
Lead sponsor:
Agency:
National Heart Centre Singapore
Agency class:
Other
Collaborator:
Agency:
National Medical Research Council (NMRC), Singapore
Agency class:
Other
Source:
National Heart Centre Singapore
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06645691