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Radiopharmaceutical

Safety of N-13 Ammonia PET MPI

Phase 4

Recruiting

Led By Daniel Juneau, MD

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 hour

Awards & highlights

Study Summary

This trial is looking at the safety of N-13 ammoniac (NH3) produced at the Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), which is not currently approved for clinical use by Health Canada. The study will also assess how physicians prescribe PET MPI procedures using NH3.

Who is the study for?

This trial is for adults needing a PET myocardial perfusion imaging test at the Centre hospitalier de l'Université de Montréal. It's not for pregnant or breastfeeding women (unless they stop breastfeeding), people who are claustrophobic, or those with contraindications to certain cardiovascular stress tests.Check my eligibility

What is being tested?

The study is testing the safety of N-13 ammonia produced by CRCHUM as a radiotracer in PET scans for heart function and blood flow. The focus is on validating the production process and assessing any changes in physician prescription practices over time.See study design

What are the potential side effects?

Since this trial focuses on safety, potential side effects may include reactions to the N-13 ammonia injection such as discomfort at the injection site or allergic reactions, although specific side effects are not listed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 hour

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 hour

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse reaction to the N-13 ammonia injection

Secondary outcome measures

Incidence of specific adverse reactions to N-13 ammonia injection

Trial Design

1Treatment groups

Experimental Treatment

Group I: Main armExperimental Treatment1 Intervention

N-13 ammonia intravenous injection; 2 injections, 3-7 MBq/kg per injection

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor

366 Previous Clinical Trials

109,637 Total Patients Enrolled

Daniel Juneau, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)

2 Previous Clinical Trials

1,500 Total Patients Enrolled

Media Library

N-13 ammonia intravenous injection (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT03275584 — Phase 4

N-13 Ammonia Safety Research Study Groups: Main arm

N-13 Ammonia Safety Clinical Trial 2023: N-13 ammonia intravenous injection Highlights & Side Effects. Trial Name: NCT03275584 — Phase 4

N-13 ammonia intravenous injection (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03275584 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the highest capacity of participants in this research project?

"Correct. Clinicaltrials.gov records demonstrate that this clinical trial, which was originally posted on January 30th 2018, is currently recruiting patients. Approximately 20 thousand participants need to be drawn from a single medical centre."

Answered by AI

Is there capacity for additional participants in this experiment?

"Right, the clinicaltrials.gov registry indicates that this study is currently enrolling participants. Initially posted on 30th January 2018 and updated most recently on 5th August 2022, it requires 20,000 volunteers to be recruited from one site."

Answered by AI

What potential adverse effects might arise from N-13 ammonia intravenous injection?

"The safety of N-13 ammonia intravenous injection was rated a 3, due to its approval as part of Phase 4 trials."

Answered by AI

How have past experiments using N-13 ammonia delivered intravenously yielded results?

"At present, there is only one active trial examining N-13 ammonia intravenous injection which has yet to reach the third phase of testing. The sites for these studies are largely located in Montréal, Quebec with a single other site participating in this research project."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety of PET MPI Using the CRCHUM N-13 Ammonia

2018. "Safety of PET MPI Using the CRCHUM N-13 Ammonia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03275584.