Safety of PET MPI Using the CRCHUM N-13 Ammonia

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

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.

Study Overview

• Status: Recruiting
• Conditions: N-13 Ammonia Safety
• Intervention / Treatment: Drug: N-13 ammonia intravenous injection

• Study Type: Interventional
• Enrollment (Estimated): 20000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Daniel Juneau, MD; Phone Number: 1-514-890-8180; Email: daniel.juneau@umontreal.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2X 0C1
      • Recruiting
      • Centre Hospitalier de l'Université de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Main arm; N-13 ammonia intravenous injection; 2 injections, 3-7 MBq/kg per injection	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse reaction to the N-13 ammonia injection	The absence or presence of adverse reactions related to the N-13 ammonia injection, as a simple yes or no. The following tools will be used to establish the presence/absence of adverse reaction: Questionnaire during and after the procedure; Vital signs monitoring before, during and after the procedure; Patient's self-reported side-effects from the procedure	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of specific adverse reactions to N-13 ammonia injection	If any adverse reactions to the N-13 ammonia injection are reported (see Primary Outcome), the incidence of specific adverse reactions will be recorded and calculated.	1 hour

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Daniel Juneau, MD, Centre Hospitalier de l'Universite de Montreal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2018
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: September 4, 2017
• First Submitted That Met QC Criteria: September 5, 2017
• First Posted (Actual): September 7, 2017

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: positron emission tomography; NH3
• Other Study ID Numbers: 17.015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No