Safety of PET MPI Using the CRCHUM N-13 Ammonia

Centre hospitalier de l'Université de Montréal (CHUM)

Status and phase

Enrolling

Phase 4

Conditions

N-13 Ammonia Safety

Treatments

Drug: N-13 ammonia intravenous injection

Study type

Interventional

Funder types

Other

Identifiers

NCT03275584

17.015

Details and patient eligibility

About

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.

Enrollment

20,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)