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Safety of PET MPI Using the CRCHUM N-13 Ammonia

StatusRecruiting
PhasePhase 4
Started2018-01-30
View on ClinicalTrials.gov ↗

Amendment history

2026-03-17
minor
2 amendments v9-v10
2 re-verifications since 2024-06-03, no change to tracked fields
2023-06-12
minor
Study Status v8
Primary completion date2027-11→2028-01
Completion date2027-11→2028-01
2022-08-05
minor
5 amendments v3-v7
5 re-verifications since 2019-01-29, no change to tracked fields
2018-02-04
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2018-01→confirmed 2018-01-30
Study sites0→1
2017-12-27
minor
Study Status, Eligibility v1
Start date2017-11→2018-01
Eligibility criteria+6 characters
Inclusion Criteria: PatientAdult patient being referred for clinically indicated positron emission t [...]
2017-09-05
minor
Original filing
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.
Trial Details
NCT Number NCT03275584
Lead Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Conditions N-13 Ammonia Safety
Enrollment 20,000 participants
Start Date 2018-01-30
Primary Completion 2028-01 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-19