NCT02648009

Metabolic Imaging of the Heart Using Hyperpolarized (13C) Pyruvate Injection

Recruiting now Phase 1 Last updated 27 January 2026

What this trial tests

Phase 1 trial testing Hyperpolarized (13) Pyruvate Injection in Hypertension in 112 participants. Currently enrolling.

Timeline

1 April 2016

Primary endpoint
1 April 2027

1 April 2027

Quick facts

Lead sponsor	Sunnybrook Health Sciences Centre
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	112
Start date	1 April 2016
Primary completion	1 April 2027
Estimated completion	1 April 2027
Sites	2 locations across Canada

Drugs / interventions tested

• Hyperpolarized (13) Pyruvate Injection — full drug profile →
• Gadolinium (GADOLINIUM) — full drug profile →

Conditions studied

• Hypertension — all drugs for Hypertension →
• Hypertrophy — all drugs for Hypertrophy →

Sponsor

Sunnybrook Health Sciences Centre — full company profile →

Who can join

Adults 19 to 75, any sex, with Hypertension or Hypertrophy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Ability of the MRI machine to produce an image of the participant's heart following an injection of Hyperpolarized Pyruvate (13C) as assessed by the physician
  Time frame: 2 years
  To demonstrate the first 13C-metabolic images of the human heart, along with the required hardware and data acquisition methods

Sponsor's own description

The prevalence of congestive heart failure (CHF) in Canada is high, representing one of the health care system's most expensive diagnoses. Despite major advances in medicine, the mortality and morbidity from CHF remains great. Currently, magnetic resonance imaging (MRI) is used for non-invasive imaging of the cardiovascular system to enable the structure and anatomy of the organ to be visualized. However, current MRI methods have limitations when assessing and aiding in the management of CHF. A new imaging method has recently been developed that is showing great promise as a tool in the management of patients with CHF. Rapid imaging of biochemical reactions within myocytes using MRI has recently become possible through the use of the Dynamic Nuclear Polarization (DNP) and dissolution method. DNP-dissolution results in an intravenous contrast agent that is "hyperpolarized", producing a magnetic signal that is enhanced by up to 100,000 fold. The particular agent is carbon-13 labelled pyruvate. In this study, we demonstrate the first 13C-metabolic images of the human heart, along with the required hardware and data acquisition methods.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hyperpolarized 13C Metabolic MRI of the Human Heart: Initial Experience.
   Cunningham CH, Lau JY, Chen AP, Geraghty BJ, et al · · 2016 · cited 284× · PMID 27635086 · DOI 10.1161/circresaha.116.309769
2. Comprehensive Literature Review of Hyperpolarized Carbon-13 MRI: The Road to Clinical Application.
   Vaeggemose M, F Schulte R, Laustsen C. · · 2021 · cited 35× · PMID 33916803 · DOI 10.3390/metabo11040219
3. Magnetic resonance imaging with hyperpolarized agents: methods and applications.
   Adamson EB, Ludwig KD, Mummy DG, Fain SB. · · 2017 · cited 32× · PMID 28384123 · DOI 10.1088/1361-6560/aa6be8