Image

Safety of PET MPI Using the CRCHUM N-13 Ammonia

Safety of PET MPI Using the CRCHUM N-13 Ammonia

Recruiting
18 years and older
All
Phase 4

Powered by AI

Overview

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

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 details
    N-13 Ammonia Safety

NCT03275584

Centre hospitalier de l'Université de Montréal (CHUM)

8 June 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.