Comparing Gadopiclenol and Gadobenate Dimeglumine for Adult Congenital Heart Disease MRI
This study is comparing two contrast agents used in MRI scans for adults with congenital heart disease (heart problems present from birth). We want to see how well Gadopiclenol, a newer contrast agent, works compared to Gadobenate dimeglumine, which is currently used. The main goal is to find out if Gadopiclenol provides similar or better image quality for heart MRI scans, including detailed measurements of blood flow. We're also looking for the best dose of Gadopiclenol to achieve this. You might be able to join if you are an adult (18 or older) with congenital heart disease, are scheduled for a routine cardiac MRI, and speak English. We are not currently recruiting, as the study status is unclear.
- Study design
- This is an interventional study comparing two different contrast agents. It plans to enroll 160 adult participants.
- What's involved
- You would receive either Gadopiclenol or Gadobenate dimeglumine before your routine cardiac MRI and chest MRA.
- Compensation
- Not stated in the trial record.
- Follow-up
- Image quality, signal-to-noise ratio, and flow measurements will be assessed within one month after the study enrollment ends.
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Comparative Effectiveness of Gadopiclenol for Evaluation of Adult Congenital Heart Anatomy and Hemodynamics
At a glance
Conditions
NCT06406517
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of California San Diego Health
San Diego, Californiastudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Albert Hsiao, MD/PhD · PRINCIPAL_INVESTIGATOR · Department of Radiology, UC San Diego
Who to contact
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Inclusion
Exclusion
What this trial measures
- Image QualityImage Quality will be assessed on a rolling basis during the study by all radiologists and will be completed within one month of the conclusion of enrollment.
Images will be qualitatively scored by three attending radiologists for quality of contrast enhancement on a 5-point likert Scale
- Signal-to-Noise Ratio (SNR)SNR will be assessed on a rolling basis during the study by the study team and will be completed within one month of the conclusion of enrollment.
Signal-to-noise will be measured from the blood pool in the aorta and main pulmonary artery and compared against myocardial signal for contrast-to-background calculations in contrast-enhanced MRA and 4D Flow signal images. This ca be readily performed by placing a region of interest (ROI) within the vessel of interest and calculating the standard deviation of signal intensities relative to mean signal intensity.
- Standard Deviation of Volumetric Flow MeasurementsStandard deviation of flow measurements will be assessed on a rolling basis during the study by all attending radiologists and will be completed within one month after the conclusion of enrollment.
We will measure standard deviation of volumetric flow measurements from the aorta and main pulmonary artery from ROIs that are typically used in our clinical routine to measure systemic and pulmonary blood flow. The standard error in these measurements will be compared between each of the four randomized conditions.