Actively Recruiting
An Open-label, Single-dose Safety and Pharmacokinetic Study of Regadenoson in Pediatric Patients Undergoing Pharmacologic Stress Perfusion Cardiac MRI
Led by GE Healthcare · Updated on 2026-05-06
54
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
G
GE Healthcare
Lead Sponsor
C
Covance
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and how the body processes (pharmacokinetics and pharmacodynamics) the vasodilator drug regadenoson in children who need a specific heart imaging test called pharmacologic stress perfusion cardiac magnetic resonance imaging (CMR). The study includes three pediatric age groups: adolescents aged 12 to less than 18 years, children aged 2 to less than 12 years, and infants aged 1 to less than 24 months who weigh at least 3 kilograms. Regadenoson is used as the stress agent, and myocardial perfusion imaging (MPI) serves as a marker to measure the drug's effects and provides a clinical evaluation for the patient. Participants will receive a single intravenous dose of regadenoson adjusted by body weight to approximate the exposure adults receive with a 400 microgram dose. The study is conducted sequentially starting with adolescents, then children, and finally infants, with safety and pharmacokinetic data reviewed by a Data Safety Monitoring Board before progressing to younger groups. The study enrolls at least 54 pediatric patients across multiple centers in Europe, with procedures performed in child-appropriate settings and sedation or general anesthesia used as needed. Resuscitation equipment and trained personnel are available during drug administration. Throughout the study, participants undergo monitoring including physical exams, vital signs (heart rate, blood pressure, oxygen saturation, body temperature), blood tests, and 12-lead electrocardiograms before and after regadenoson administration. Blood levels of regadenoson are measured at several time points post-dose. Imaging with dynamic first-pass perfusion MRI and myocardial perfusion reserve analysis occurs about one hour after dosing to assess heart response. Safety data, drug levels, heart responses, and imaging results are recorded to evaluate the drug's effects and tolerability in these pediatric patients.
CONDITIONS
Brief Title
A Study to Evaluate the Safety and Pharmacokinetics of Regadenoson in Pediatric Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adolescent aged 12 to less than 18 years, child aged 2 to less than 12 years, or infant aged 1 to less than 24 months
- Participant weighs at least 3 kg
- Needs a clinically indicated pharmacologic stress perfusion cardiac MRI and is considered fit for it by the investigator
- Stable medication regimen for at least 7 days with no changes affecting heart rate or blood pressure
- Patients and parents or guardians likely to comply and complete the study
- Post-menarchal females must have a negative urine pregnancy test at screening and pre-dose
- Post-menarchal females must practice abstinence or use effective birth control for at least 30 days before enrollment
You will not qualify if you...
- Prior allergic reaction to gadolinium contrast agents, regadenoson, aminophylline, or their components
- Contraindications to MRI such as cochlear implants or implanted cardiac devices
- Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2 within 24 hours before exam
- Pregnant or lactating females, or females not using acceptable birth control
- Clinically significant ongoing medical conditions or lab abnormalities posing safety risks
- Second or third degree atrioventricular block or sick sinus syndrome with or without pacemaker
- Unstable or actively treated bronchoconstrictive or bronchospastic lung disease
- Blood pressure or heart rate outside acceptable ranges for age group at screening
- Use of experimental drugs or devices within 30 days prior to dosing
- Use of methylxanthine-containing products within 48 hours before dosing
- Use of aminophylline or theophylline within 24 hours or dipyridamole within 48 hours before dosing
- History of alcohol abuse or drug addiction
- Smoking more than 5 cigarettes or equivalent per day and inability to abstain from midnight before dosing until end of study
- Positive urine drug screen at screening for substances including amphetamines, barbiturates, cannabinoids, cocaine, ethanol, and opiates
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants undergo a pharmacologic stress perfusion cardiac MRI using regadenoson as the stress agent to evaluate heart function and drug effects.
1 visit (in-person)
Duration - Up to 70 hours after regadenoson administration
Participants are monitored for safety and drug effects following administration of regadenoson, including physical examinations, vital signs, ECGs, and blood tests.
Multiple assessments during and after the diagnostic visit
Trial Site Locations
Total: 5 locations
1
Paris Public Hospitals System; Necker Hospital for Sick Children
Paris, France, 75015
Terminated
2
Mitera Hospital
Athens, Greece, 15123
Completed
3
Bambino Gesu Children Hospital
Roma, Italy, 00165
Actively Recruiting
4
Bristol Royal Hospital for Children
Bristol, United Kingdom, BS28BJ
Not Yet Recruiting
5
King's College London, Rayne Institute
London, United Kingdom, SE1 7EH
Actively Recruiting
Research Team
M
Michelle Straszacker
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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