Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06406517
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-05-06
Brief Title:
Comparative Effectiveness of Gadopiclenol for Evaluation of Adult Congenital Heart Anatomy and Hemodynamics
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Comparative Effectiveness of Gadopiclenol for Evaluation of Adult Congenital Heart Anatomy and Hemodynamics
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn how well and at what doses gadopiclenol a new intravenous IV contrast agent used for MRI works to produce high-quality MRI images of the heart in patients with a history of congenital heart disease when compared to gadobenate dimeglumine the IV contrast agent that is normally used at our institution for heart cardiac MRI The main questions it aims to answer are
Does using gadopiclenol result in similar or superior image quality similar signal-to-noise ratio SNR and similar flow measurements with 4-dimensional 4D flow cardiac MRI when compared to gadobenate dimeglumine
At what doses does gadopiclenol result in similar image quality using the above metrics for cardiac MRI when compared to gadobenate dimeglumine
Researchers will compare cardiac MRI images obtained after administration of gadopiclenol to cardiac MRI images obtained after administration of gadobenate dimeglumine called the standard of care treatment to see if the images are of similar or superior quality
Participants will
Be randomized to receive either gadopiclenol at one of three different doses or gadobenate dimeglumine before their congenital heart cardiac MRI
Undergo their congenital heart cardiac MRI as they would during the course of normal clinical care
Does using gadopiclenol result in similar or superior image quality similar signal-to-noise ratio SNR and similar flow measurements with 4-dimensional 4D flow cardiac MRI when compared to gadobenate dimeglumine
At what doses does gadopiclenol result in similar image quality using the above metrics for cardiac MRI when compared to gadobenate dimeglumine
Researchers will compare cardiac MRI images obtained after administration of gadopiclenol to cardiac MRI images obtained after administration of gadobenate dimeglumine called the standard of care treatment to see if the images are of similar or superior quality
Participants will
Be randomized to receive either gadopiclenol at one of three different doses or gadobenate dimeglumine before their congenital heart cardiac MRI
Undergo their congenital heart cardiac MRI as they would during the course of normal clinical care
Detailed Description:
At the University of California San Diego UCSD we have developed a premier advanced clinical cardiovascular imaging program which is a critical component of our Adult Congenital Heart Association ACHA-accredited adult congenital heart program Central to these programs is 4D Flow MRI which enables hemodynamic assessment of patients with repaired and unrepaired congenital heart disease Adults with congenital heart disease require routine MRI for surveillance and management of complications of disease and repairs and 4D Flow allows us to reliably perform these exams efficiently and accurately Multiple works by our group and confirmed by others have highlighted the value of 4D Flow MRI for evaluating this patient population and for vascular imaging applications beyond the heart
Gadopiclenol is a recently FDA-approved intravenous extracellular gadolinium contrast agent indicated for use in MRI Though it has been shown to be effective in detection of central nervous system CNS lesions and of lesions outside the CNS its performance in cardiovascular imaging is unknown particularly in cardiac MRI performed for evaluation of adult congenital heart disease We therefore seek to evaluate whether use of gadopiclenol results in superior image quality compared to and therefore may be used in place of gadobenate dimeglumine our current standard of care in 4D Flow MRI and MR Angiography MRA
In our current clinical practice like many others gadobenate dimeglumine at 03 mLkg 015 mmolkg is our standard of care for vascular enhancement and cardiac MRI favored due to its long blood pool residence time which parallels the longer acquisition time for 4D Flow MRI 10 minutes and its strong T1 shortening properties Gadopiclenol with its stronger T1 shortening properties and similar pharmacokinetics may achieve similar effects but as a macrocyclic agent is a more stable gadolinium agent and theoretically may have a better retention profile than older linear agents due to its lower approved dose We therefore seek to determine whether gadopiclenol may be used in place of gadobenate dimeglumine for contrast-enhanced 4D Flow MRI and MRA Since the optimal dose of gadopiclenol for this purpose is unknown we will assess the relative performance of gadopiclenol across a dose range
Standard dosing for gadopiclenol for CNS and abdominal imaging in adult and pediatric patients is 005 mmolkg actual body weight equivalent to 01 mLkg However its safety has been evaluated at doses ranging from 0025 mmolkg to 03 mmolkg We therefore plan to assess the signal to noise ratio and image quality of patients undergoing cardiac MRI using gadopiclenol at three doses 0075 mmolkg 010 mmolkg 015 mmolkg against our standard of care gadobenate dimeglumine at 03 mLkg 015 mmolkg We hypothesize that gadopiclenol at each dose will be non-inferior to gadobenate dimeglumine achieving similar qualitative image quality similar SNR and similar standard deviation amongst flow measurements with 4D Flow MRI There is a strong possibility that gadopiclenol at an equimolar gadolinium dose to gadobenate dimeglumine will provide superior qualitative image quality and superior SNR in contrast-enhanced MRA and reduce standard deviation amongst flow measurements with 4D Flow MRI
Gadopiclenol is a recently FDA-approved intravenous extracellular gadolinium contrast agent indicated for use in MRI Though it has been shown to be effective in detection of central nervous system CNS lesions and of lesions outside the CNS its performance in cardiovascular imaging is unknown particularly in cardiac MRI performed for evaluation of adult congenital heart disease We therefore seek to evaluate whether use of gadopiclenol results in superior image quality compared to and therefore may be used in place of gadobenate dimeglumine our current standard of care in 4D Flow MRI and MR Angiography MRA
In our current clinical practice like many others gadobenate dimeglumine at 03 mLkg 015 mmolkg is our standard of care for vascular enhancement and cardiac MRI favored due to its long blood pool residence time which parallels the longer acquisition time for 4D Flow MRI 10 minutes and its strong T1 shortening properties Gadopiclenol with its stronger T1 shortening properties and similar pharmacokinetics may achieve similar effects but as a macrocyclic agent is a more stable gadolinium agent and theoretically may have a better retention profile than older linear agents due to its lower approved dose We therefore seek to determine whether gadopiclenol may be used in place of gadobenate dimeglumine for contrast-enhanced 4D Flow MRI and MRA Since the optimal dose of gadopiclenol for this purpose is unknown we will assess the relative performance of gadopiclenol across a dose range
Standard dosing for gadopiclenol for CNS and abdominal imaging in adult and pediatric patients is 005 mmolkg actual body weight equivalent to 01 mLkg However its safety has been evaluated at doses ranging from 0025 mmolkg to 03 mmolkg We therefore plan to assess the signal to noise ratio and image quality of patients undergoing cardiac MRI using gadopiclenol at three doses 0075 mmolkg 010 mmolkg 015 mmolkg against our standard of care gadobenate dimeglumine at 03 mLkg 015 mmolkg We hypothesize that gadopiclenol at each dose will be non-inferior to gadobenate dimeglumine achieving similar qualitative image quality similar SNR and similar standard deviation amongst flow measurements with 4D Flow MRI There is a strong possibility that gadopiclenol at an equimolar gadolinium dose to gadobenate dimeglumine will provide superior qualitative image quality and superior SNR in contrast-enhanced MRA and reduce standard deviation amongst flow measurements with 4D Flow MRI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None