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NCT06645691RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 6 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
200 (estimated)
First submitted
2 Oct 2024
Start date
17 Oct 2024
Primary completion date
31 May 2028
Lead sponsor
National Heart Centre Singapore
NCT number
NCT06645691

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 200
  • From 17 Oct 2024 to the primary completion date, 31 May 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Standard contraindications for magnetic resonance procedures (such as implantable medical devices, suspected presence of surgical apparatus or shrapnel, severe claustrophobia)

Other illness

  • Known allergies to pyruvate or any of its components

Lab values

  • Unstable medical conditions (such as symptomatic heart failure, unstable hypertension/glucose levels as determined by investigators, symptomatic arrhythmias, angina)

Other

  • Pregnant or nursing women

Who the study is looking for

  • 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

Age in the registry: 21 years to 99 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
National Heart Centre Singapore
Coordinator of this site? Confirm its status
SingaporeSingaporeRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.