Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645691
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
Hyperpolarized MR Imaging with Carbon-13 Pyruvate in the Human Body
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Hyperpolarized MR Imaging with Carbon-13 Pyruvate in the Human Body
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POLARIC-13
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 10000 to 100000-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 andor 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 11 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 probes to be hyperpolarized and placing the mixture in a polarizer at a magnetic field typically of 30-50 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 10000 to 100000-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 1200 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 cardiovascularcardiometabolic 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
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 11 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 probes to be hyperpolarized and placing the mixture in a polarizer at a magnetic field typically of 30-50 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 10000 to 100000-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 1200 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 cardiovascularcardiometabolic 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None