Safety of N-13 Ammonia PET MPI

Recruiting at 1 trial location

Overseen By Daniel Juneau, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

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

Disqualifiers: Pregnancy, Claustrophobia, Breastfeeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

20000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a new version of N-13 ammonia, a substance used in heart imaging tests called PET MPI. The goal is to determine if this new version, produced at a specific research center, safely assists doctors in checking for blocked heart arteries. The trial seeks adults already scheduled for a heart imaging test at the Montreal hospital. As an experimental version of N-13 ammonia, the trial will ensure its safety and observe potential changes in doctors' prescribing habits. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand how it can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a contraindication (a specific reason not to use) to certain stress test medications like dipyridamole, aminophylline, or dobutamine, you may not be eligible to participate.

What is the safety track record for N-13 ammonia intravenous injection?

Research has shown that N-13 ammonia, used in a heart imaging test called PET MPI, is generally safe. Studies have found it effective for heart imaging in certain situations. However, like any radioactive material, it carries a small cancer risk. Therefore, doctors use the smallest amount needed for a clear image.

The FDA in the U.S. has already approved N-13 ammonia for these heart imaging tests, indicating it is usually well-tolerated when used correctly. This study tests a new batch of N-13 ammonia produced at a specific research center to ensure the safety of this production process. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

N-13 ammonia PET MPI is unique because it uses a radioactive tracer, N-13 ammonia, to create detailed images of blood flow to the heart. Unlike traditional methods like SPECT MPI, which uses different tracers such as technetium or thallium, N-13 ammonia offers higher resolution images. This precise imaging helps doctors better assess heart health and make more accurate diagnoses, which is why researchers are excited about its potential.

What evidence suggests that N-13 ammonia is effective for PET MPI?

Research shows that N-13 ammonia, which participants in this trial will receive, effectively images the heart's blood flow. Studies indicate that this radiotracer (a type of radioactive substance) provides clear pictures of blood movement through the heart, aiding in the detection of blocked arteries. The FDA in the United States has already approved N-13 ammonia for these uses. It reliably detects coronary artery disease, making it dependable for identifying issues with heart blood flow. ^{1 5 6 7 8}

Who Is on the Research Team?

Daniel Juneau, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

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.

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

Claustrophobic patient unable to undergo the examination

I am breastfeeding and not willing to stop.

I cannot take certain heart stress test drugs or do an exercise stress test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive N-13 ammonia intravenous injection for PET MPI

1 day

1 visit (in-person)

Follow-up

Participants are monitored for adverse reactions to the N-13 ammonia injection

1 hour

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• N-13 ammonia intravenous injection

Trial Overview 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.

How Is the Trial Designed?

Group I: Main arm Experimental Treatment 1 Intervention

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

N-13 ammonia intravenous injection is already approved in United States, European Union for the following indications:

Approved in United States as Ammonia N 13 Injection for:

• Diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.

Approved in European Union as N-13 Ammonia for:

• Diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Published Research Related to This Trial

In a study involving nine healthy volunteers, over 90% of the blood activity from [13N] ammonia was identified as the tracer within the first two minutes post-injection, indicating its rapid uptake.

However, by 3-5 minutes, significant contamination from metabolites like [13N]glutamine and urea emerged, accounting for 18%-50% of blood activity, highlighting the need for corrections in arterial input function to ensure accurate myocardial blood flow quantification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic fate of [13N]ammonia in human and canine blood. Rosenspire, KC., Schwaiger, M., Mangner, TJ., et al.[2015]

The study successfully produced [13N]ammonia in high yields (up to 800 mCi) using a novel in-line processing method with irradiated water, demonstrating an efficient approach for generating this radiopharmaceutical for PET imaging.

Combining hydrogen and ethanol as target additives improved the production efficiency of [13N]ammonia at high beam doses, suggesting a potential optimization strategy for radiopharmaceutical synthesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-target production of [13N]ammonia: target design, products, and operating parameters. Berridge, MS., Landmeier, BJ.[2019]

N13-ammonia PET imaging using the Ionetix ION-12SC system produced high-quality myocardial perfusion images in 97 patients, with 91.8% of images rated as good or excellent, indicating its efficacy for clinical use.

The radiation exposure for patients was relatively low, with doses of 0.7 mSv for rest scans and 2.1 mSv for rest-stress scans, suggesting that N13-ammonia PET imaging is a safe option for assessing heart function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial clinical experience of N13-ammonia myocardial perfusion PET/CT using a compact superconducting production system. Pieper, J., Patel, VN., Escolero, S., et al.[2023]

The production process for the PET radiopharmaceutical [N]NH3 was validated to ensure high safety and purity, achieving a radiochemical yield of 26.3% to 61.5% and 100% radiochemical purity, with no bacterial growth detected in sterility tests.

The careful standardization of all production steps, including online purification and additional contaminant analysis, ensures that [N]NH3 is safe for human use in PET imaging of the myocardium.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The strange case of the [13N]NH3: validation of the production process for human use. Statuto, M., Galli, E., Bertagna, F., et al.[2019]

The biodistribution study of (13)N-ammonia in five healthy subjects showed that the highest concentrations were found in the heart and liver, indicating these organs are key areas for this tracer's action.

The effective dose of radiation from (13)N-ammonia was found to be relatively low (6.58E-03 mSv/MBq), suggesting that it is safe for use in multiple PET scans per year without significant radiation risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biodistribution and estimation of radiation-absorbed doses in humans for 13N-ammonia PET. Yi, C., Yu, D., Shi, X., et al.[2015]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK23075/

[13N]Ammonia - NCBI - NIH 13 N-labeled compound that has been developed as a positron emission tomography (PET) imaging agent for assessing regional blood flow in tissues.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03275584?term=AREA%5BInterventionSearch%5D(AMMONIA)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=4

Safety of PET MPI Using the CRCHUM N-13 Ammonia | ... Positron emission tomography (PET) myocardial perfusion imaging (MPI) is an examination that helps to assess the function and perfusion of the heart.

3. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2011/022119s001lbl.pdf

Ammonia N 13 Injection for intravenous use Ammonia N 13 Injection is indicated for diagnostic Positron. Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions ...

4. statpearls.com statpearls.com/point-of-care/162961

Nitrogen-13 Ammonia Radiopharmaceutical N-13 ammonia is an injectable FDA-approved tracer for myocardial perfusion evaluation at rest and stress tests in patients with existing or suspected coronary ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6382649/

Diagnostic accuracy of 13N-ammonia myocardial perfusion ... PET-MPI with 13 N-ammonia affords high sensitivity and overall accuracy for detecting CAD. The addition of coronary artery calcium score (CACS) can improve CAD ...

6. siemens-healthineers.com siemens-healthineers.com/en-us/molecular-imaging/petnet-solutions-mibr/ammonia-n13-injection

Ammonia N 13 Injection Ammonia N 13 Injection may increase the risk of cancer. Use t he smallest dose necessary for imaging and ensure safe handling to protect the patient and health ...

7. dailymed.nlm.nih.gov dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=85882893-0661-46c2-a5f2-a73f6ea4fb5a

ammonia n-13 injection - DailyMed - NIH Ammonia N 13 Injection is a radioactive diagnostic agent for Positron Emission Tomography (PET) indicated for diagnostic PET imaging of the myocardium under ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2007/22119s000_MedR.pdf

NDA #22-119, Ammonia N 13 Injection - accessdata.fda.gov Furthermore, the recent scientific literature supports the safety and efficacy of ammonia N13 PET imaging of the myocardium to evaluate ...