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

NCT06645691 | Recruiting Phase 2 DMC

• 1 other identifier: POLARIC-13
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Cardiometabolic Syndrome; Cancer Diagnosis; Cardiovascular Diseases; Healthy Volunteers

Keywords

Carbon-13 Pyruvate; Magnetic Resonance Imaging; Lactate; Alanine; Bicarbonate; Hyperpolarized Pyruvate (13C) Injection

Outcome Measures

Primary Outcomes (1)

• Feasibility and reproducibility of Imaging Technique

  Feasibility and reproducibility of the imaging technique in healthy volunteers and patients with cardiovascular and/or cardiometabolic diseases

  30 - 45 minutes post dose

Study Arms (1)

Hyperpolarized Pyruvate [13C] Injection

EXPERIMENTAL

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.

Drug: Hyperpolarized 13C-pyruvate

Interventions

Hyperpolarized 13C-pyruvate DRUG

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

Also known as: (13C) pyruvate, Hyperpolarized Carbon C 13 Pyruvate

Hyperpolarized Pyruvate [13C] Injection

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Standard contraindications for magnetic resonance procedures (such as implantable medical devices, suspected presence of surgical apparatus or shrapnel, severe claustrophobia)
• Unstable medical conditions (such as symptomatic heart failure, unstable hypertension/glucose levels as determined by investigators, symptomatic arrhythmias, angina)
• Pregnant or nursing women
• Known allergies to pyruvate or any of its components

Sponsors & Collaborators

• National Heart Centre Singapore: lead
• National Medical Research Council (NMRC), Singapore: collaborator

Study Sites (1)

National Heart Centre Singapore

Singapore, 169609, Singapore

RECRUITING

MeSH Terms

Conditions

Heart Failure; Metabolic Syndrome; Cardiovascular Diseases

Interventions

Pyruvic Acid

Condition Hierarchy (Ancestors)

Heart Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyruvates; Keto Acids; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Calvin WL Chin

CONTACT

6568449055; CAMI@nhcs.com.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 17, 2024
• Study Start: October 17, 2024
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: December 6, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)