Congenital Heart DiseasePhase 3NCT06406517
Comparative Effectiveness of Gadopiclenol for Evaluation of Adult Congenital Heart Anatomy and Hemodynamics
A Phase 3 study testing Gadopiclenol and Gadobenate dimeglumine in people with Congenital Heart Disease, run by University of California, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Gadopiclenol and Gadobenate dimeglumine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2024to 23 Aug 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥ 18 years old)
- History of congenital heart disease and scheduled to undergo standard of care cardiac MRI and chest MRA as part of routine clinical care
- English is patient's primary spoken language
Who cannot join
- Pediatric patients
- Pregnant patients
- Patients with ongoing acute kidney injury (AKI) or severe, chronic kidney disease (GFR < 30 mL/min/1.73m2)
- History of hypersensitivity reaction to gadolinium based contrast agent
- English is not the patient's primary spoken language
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego Health
San Diego, California, 92037
About this study
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 dose(s) does gadopiclenol result in similar image quality (using the above metrics) for cardiac MRI when compared to gadobenate dimeglumine?
Read more
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.
Read the detailed description
At the University of California San Diego (UCSD), the investigators 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. The investigators 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 0.3 mL/kg (0.15 mmol/kg) 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. The investigators 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, the investigators 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 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg). However, its safety has been evaluated at doses ranging from 0.025 mmol/kg to 0.3 mmol/kg. The investigators therefore plan to assess the signal to noise ratio and image quality of patients undergoing cardiac MRI using gadopiclenol at three doses (0.075 mmol/kg, 0.10 mmol/kg, 0.15 mmol/kg) against our standard of care (gadobenate dimeglumine at 0.3 mL/kg (0.15 mmol/kg)). The investigators 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.
- Conditions
- Congenital Heart Disease
- Being tested
- Gadopiclenol, Gadobenate dimeglumine
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GadopiclenolDrug
Also called Vueway
Gadopiclenol is an FDA-approved gadolinium-based contrast agent (GBCA) for neurological and abdominal contrast-enhanced MRI. Participants will receive this contrast agent at one of three different doses prior to undergoing a congenital heart cardiac MRI/MRA. This contrast agent will be compared to gadobenate dimeglumine, the standard-of-care.
Gadobenate dimeglumineDrug
Also called Multihance
Gadobenate dimeglumine is an FDA-approved GBCA that is used in standard clinical practice at UCSD for contrast-enhanced MRI/MRA studies, including cardiac MRI/MRA. This contrast agent is the standard of care to which gadopiclenol will be compared.
| Study group | Role | What they receive |
|---|---|---|
| Gadobenate dimeglumine 0.15 mmol/kg (standard of care) | Active comparator | Not described Receives: Drug: Gadobenate dimeglumine |
| Gadopiclenol 0.075 mmol/kg | Experimental | Not described Receives: Drug: Gadopiclenol |
| Gadopiclenol 0.10 mmol/kg | Experimental | Not described Receives: Drug: Gadopiclenol |
| Gadopiclenol 0.15 mmol/kg | Experimental | Not described Receives: Drug: Gadopiclenol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image Quality
Images will be qualitatively scored by three attending radiologists for quality of contrast enhancement on a 5-point likert Scale
Measured: Image 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.
Signal-to-Noise Ratio (SNR)
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.
Measured: 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.
Standard Deviation of Volumetric Flow Measurements
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.
Measured: Standard 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start5 Aug 2024
- Primary completion23 Apr 2026
- Study completion23 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a prospective, single center, parallel group, double-blinded, randomized clinical trial. The study will be conducted at UC San Diego MRI suites. Study participants will be randomized into one of four study arms prior to their MRI: Gadopiclenol 0.075 mmol/kg, gadopiclenol 0.10 mmol/kg, gadopiclenol 0.15 mmol/kg, gadobenate dimeglumine 0.15 mmol/kg (standard of care).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Bracco Imaging S.p.A.
- Responsible party
- Principal investigator, Albert Hsiao, University of California, San Diego
- Investigators
- Albert Hsiao, MD/PhD, Principal investigator, Department of Radiology, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406517
- Sponsor's protocol ID
- IRB #809813
- Status last verified
- Oct 2026
- First submitted
- 6 May 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jacobs K, Hahn L, Horowitz M, Kligerman S, Vasanawala S, Hsiao A. Hemodynamic Assessment of Structural Heart Disease Using 4D Flow MRI: How We Do It. AJR Am J Roentgenol. 2021 Dec;217(6):1322-1332. doi: 10.2214/AJR.21.25978. Epub 2021 Jun 2.
PubMed 34076463Kebebew E, Tresler PA, Siperstein AE, Duh QY, Clark OH. Normal thyroid pathology in patients undergoing thyroidectomy for finding a RETgene germline mutation: a report of three cases and review of the literature. Thyroid. 1999 Feb;9(2):127-31. doi: 10.1089/thy.1999.9.127.
PubMed 10090311Hsiao A, Alley MT, Massaband P, Herfkens RJ, Chan FP, Vasanawala SS. Improved cardiovascular flow quantification with time-resolved volumetric phase-contrast MRI. Pediatr Radiol. 2011 Jun;41(6):711-20. doi: 10.1007/s00247-010-1932-z. Epub 2011 Jan 11.
PubMed 21221566
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Gadopiclenol for Evaluation of Adult Congenital Heart Anatomy and Hemodynamics
- ClinicalTrials.gov ID
- NCT06406517
- Acronym / sponsor ID
- IRB #809813
- Conditions
- Congenital Heart Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Bracco Imaging S.p.A.
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 23 Apr 2026 (actual)
- Study completion
- 23 Aug 2026 (actual)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 dose(s) 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), the investigators 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. The investigators 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 0.3 mL/kg (0.15 mmol/kg) 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. The investigators 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, the investigators 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 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg). However, its safety has been evaluated at doses ranging from 0.025 mmol/kg to 0.3 mmol/kg. The investigators therefore plan to assess the signal to noise ratio and image quality of patients undergoing cardiac MRI using gadopiclenol at three doses (0.075 mmol/kg, 0.10 mmol/kg, 0.15 mmol/kg) against our standard of care (gadobenate dimeglumine at 0.3 mL/kg (0.15 mmol/kg)). The investigators 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- This will be a prospective, single center, parallel group, double-blinded, randomized clinical trial. The study will be conducted at UC San Diego MRI suites. Study participants will be randomized into one of four study arms prior to their MRI: Gadopiclenol 0.075 mmol/kg, gadopiclenol 0.10 mmol/kg, gadopiclenol 0.15 mmol/kg, gadobenate dimeglumine 0.15 mmol/kg (standard of care).
| Arm | Type | Receives |
|---|---|---|
| Gadobenate dimeglumine 0.15 mmol/kg (standard of care) | Active comparator | Drug: Gadobenate dimeglumine |
| Gadopiclenol 0.075 mmol/kg | Experimental | Drug: Gadopiclenol |
| Gadopiclenol 0.10 mmol/kg | Experimental | Drug: Gadopiclenol |
| Gadopiclenol 0.15 mmol/kg | Experimental | Drug: Gadopiclenol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (≥ 18 years old)
- History of congenital heart disease and scheduled to undergo standard of care cardiac MRI and chest MRA as part of routine clinical care
- English is patient's primary spoken language
Key exclusion criteria (5 listed)
- Pediatric patients
- Pregnant patients
- Patients with ongoing acute kidney injury (AKI) or severe, chronic kidney disease (GFR < 30 mL/min/1.73m2)
- History of hypersensitivity reaction to gadolinium based contrast agent
- English is not the patient's primary spoken language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GadopiclenolAlso: VuewayGadopiclenol is an FDA-approved gadolinium-based contrast agent (GBCA) for neurological and abdominal contrast-enhanced MRI. Participants will receive this contrast agent at one of three different doses prior to undergoing a congenital heart cardiac MRI/MRA. This contrast agent will be compared to gadobenate dimeglumine, the standard-of-care. | Drug | Gadopiclenol 0.075 mmol/kg, Gadopiclenol 0.10 mmol/kg, Gadopiclenol 0.15 mmol/kg |
| Gadobenate dimeglumineAlso: MultihanceGadobenate dimeglumine is an FDA-approved GBCA that is used in standard clinical practice at UCSD for contrast-enhanced MRI/MRA studies, including cardiac MRI/MRA. This contrast agent is the standard of care to which gadopiclenol will be compared. | Drug | Gadobenate dimeglumine 0.15 mmol/kg (standard of care) |
Primary outcome
Image Quality
Time frame: Image 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)
Time frame: 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 Measurements
Time frame: Standard 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 34076463Jacobs K, Hahn L, Horowitz M, Kligerman S, Vasanawala S, Hsiao A. Hemodynamic Assessment of Structural Heart Disease Using 4D Flow MRI: How We Do It. AJR Am J Roentgenol. 2021 Dec;217(6):1322-1332. doi: 10.2214/AJR.21.25978. Epub 2021 Jun 2.
- Background: PubMed 10090311Kebebew E, Tresler PA, Siperstein AE, Duh QY, Clark OH. Normal thyroid pathology in patients undergoing thyroidectomy for finding a RETgene germline mutation: a report of three cases and review of the literature. Thyroid. 1999 Feb;9(2):127-31. doi: 10.1089/thy.1999.9.127.
- Background: PubMed 21221566Hsiao A, Alley MT, Massaband P, Herfkens RJ, Chan FP, Vasanawala SS. Improved cardiovascular flow quantification with time-resolved volumetric phase-contrast MRI. Pediatr Radiol. 2011 Jun;41(6):711-20. doi: 10.1007/s00247-010-1932-z. Epub 2011 Jan 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert Hsiao, MD/PhD principal investigator
Department of Radiology, UC San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gadopiclenol and Gadobenate dimeglumine in people with Congenital Heart Disease, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image Quality (time frame: Image 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06406517, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.