Comparative Effectiveness of Gadopiclenol for Evaluation of Adult Congenital Heart Anatomy and Hemodynamics

NCT06406517 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: IRB #809813
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (3)

• Image Quality

  Images will be qualitatively scored by three attending radiologists for quality of contrast enhancement on a 5-point likert Scale

  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.

  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.

  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.

Study Arms (4)

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

Interventions

Gadopiclenol DRUG

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.

Also known as: Vueway

Gadopiclenol 0.075 mmol/kg; Gadopiclenol 0.10 mmol/kg; Gadopiclenol 0.15 mmol/kg

Gadobenate dimeglumine DRUG

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.

Also known as: Multihance

Gadobenate dimeglumine 0.15 mmol/kg (standard of care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• Bracco Imaging S.p.A.: collaborator

Study Sites (1)

University of California San Diego Health

San Diego, California, 92037, United States

Location

Related Publications (3)

• 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.

  PMID: 34076463 BACKGROUND

• Kebebew 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.

  PMID: 10090311 BACKGROUND

• Hsiao 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.

  PMID: 21221566 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

gadopiclenol; gadobenic acid

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Albert Hsiao, MD/PhD

  Department of Radiology, UC San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roshun Sankaran, MD

CONTACT

858-246-2196; rsankaran@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The study investigator/postdoctoral researcher/research coordinator will randomize participants into a study arm based on the day the participant is scheduled to receive their MRI. Participants will not be told which study arm they are being randomized into. MRI techs will be told which arm patients are randomized in to so that the correct IV contrast drug and dose will be administered. All MRIs will be read by cardiac radiologists, who will also not be told which study arm a participant was in. The master list of randomized participants will be maintained by the study investigator/postdoctoral researcher/research coordinator.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Residence

Model Details: 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).

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: May 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)