Recruiting

N-13 Ammonia

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT03275584

Conditions

N-13 Ammonia Safety

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

N-13 ammonia intravenous injection

Study Details

Brief summary:

Positron emission tomography (PET) myocardial perfusion imaging (MPI) is an examination that helps to assess the function and perfusion of the heart. Completion of this examination requires the injection of a small dose of a radiotracer (a radioactive substance).

PET MPI is a state-of-the-art non-invasive cardiac imaging tool. The main goal of the PET MPI examination is to assess if one or more of the arteries feeding blood to your heart are blocked. This examination replaces an older technology (single photon emission computed tomography, or SPECT), and allows the obtention of more accurate information, and new information that the older SPECT technology did not assess. The radiation dose received as part of the procedure is also smaller with PET versus SPECT.

One of the substances which can be used for PET MPI is called N-13 ammoniac (NH3). For this clinical study, NH3 which will be produced at the Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), per the standards and methods prescribed by Health Canada. NH3 is not currently approved for clinical use by Health Canada. It is thus considered and experimental substance in the context of this study.

Participants will undergo PET MPI with the CRCHUM NH3. The PET MPI procedure itself is not an experimental procedure and is not part of the research protocol. Only the use of NH3 produced at the CRCHUM is experimental.

The main objective of this research study is to validate the production process and assess the safety of the NH3 produced at the CRCHUM cyclotron. Secondary objectives include the assessment of prescription practices amongst physicians who refer patients for PET MPI, and how they will change over time.

Conditions

N-13 Ammonia Safety

Study ID

NCT03275584

Start date

Jan 30, 2018

Status verified date

Mar, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult patient being referred for clinically indicated positron emission tomography myocardial perfusion imaging at the Centre hospitalier de l'Université de Montréal

Exclusion Criteria:

  • Pregnant women
  • Claustrophobic patient unable to undergo the examination
  • Breastfeeding women unwilling to temporarily stop breastfeeding
  • Patient with contra-indication to: dipyridamole, aminophylline, dobutamine or exercise stress test (depending on the method of cardiovascular stress test chosen)

Study Design

Enrollment

20000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Main arm

N-13 ammonia intravenous injection; 2 injections, 3-7 MBq/kg per injection

Interventions

N-13 ammonia intravenous injection

Participants will receive two injections of N-13 ammonia, once at "rest" and once at "stress" before undergoing positron emission tomography myocardial perfusion imaging

Primary outcome measure

  • Adverse reaction to the N-13 ammonia injection [ Time Frame: 1 hour ]

Central Contacts and Locations

Central contacts

Daniel Juneau, MD

1-514-890-8180daniel.juneau@umontreal.ca

Locations

Centre Hospitalier de l'université de Montréal

Recruiting

Montreal, Quebec, Canada, H2X 0C1

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Keywords

  • positron emission tomography
  • NH3

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2026-03-19.