Clinical trial NCT03275584: Safety of PET MPI Using the CRCHUM N-13 Ammonia
Official title: Sûreté de la Perfusion Myocardique Par la Tomographie d'émission Par Positron Avec l'Ammoniaque marqué au N-13 du Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: N-13 Ammonia Safety
Keywords: positron emission tomography
NH3
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2017-09-07
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Adverse reaction to the N-13 ammonia injection
timeFrame: 1 hour
Secondary outcomes:
measure: Incidence of specific adverse reactions to N-13 ammonia injection
timeFrame: 1 hour
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'université de Montréal
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Daniel Juneau, MD
role: PRINCIPAL_INVESTIGATOR
References: