Liver LesionNCT06596616
Gadopiclenol vs Gadoxetate MRI for Liver Lesions
An observational study of Liver Lesion, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The overall purpose of this study is to establish noninferiority of gadopiclenol MRI compared to gadoxetate MRI in terms of image quality and lesion detection/conspicuity in patients undergoing clinically indicated liver MRI in a prospective study. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Lesion
- What is being tested?
- Radiology and Gadopiclenol
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with undergoing MRI for management of chronic liver disease, liver lesions, and/or tumor treatment follow up
Who may be able to join
- Adult patients of both genders and all ethnic groups with clinical indication of MRI for chronic liver disease and/or focal lesion and/or tumor treatment follow-up.
Who cannot join
- Acute renal insufficiency.
- Severe chronic renal insufficiency (GFR <30 mL/min/1.73 m2).
- Age <18y.
- Unable or unwilling to give informed consent.
- Contraindications for MRI (such as pacemakers, infusion pumps, pregnancy, allergy or previous adverse reactions to gadolinium contrast agents, severe claustrophobia).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: MR Image Quality and Liver Lesion Detection With Gadopiclenol: Comparison With Gadoxetate Disodium
The overall purpose of this study is to establish noninferiority of gadopiclenol MRI compared to gadoxetate MRI in terms of image quality and lesion detection/conspicuity in patients undergoing clinically indicated liver MRI in a prospective study. The research will be utilizing MRI; with enrollment goal of 75 subjects over the course of two years.
Read the detailed description
Gadopiclenol is a new macrocyclic gadolinium-based contrast agent (GBCA) which has higher relaxivity than other GBCAs with a potential use of lower dose and comparable pharmacokinetics to other agents in preclinical studies. In a rodent model of liver metastasis, gadopiclenol showed strong enhancement with comparable pharmacokinetics to other extracellular GBCAs (EC-GBCAs). It was found to have a potential of either improving lesion conspicuity or providing similar accuracy in lesion detection with a reduced Gadolinium (Gd) dose. In a rat brain tumor model, half dose (0.05 mmol/kg) of gadopiclenol yielded comparable contrast-to-noise ratio (CNR) and morphological characterization of brain tumors compared to other EC-GBCAs. There are also a few clinical studies in which no safety concern was raised with the use of gadopiclenol. No dose adjustment for children or patients with renal impairment was found to be required. There is no study in the literature assessing the enhancement properties of gadopiclenol in abdominal imaging and comparing it with a hepatobiliary agent for image quality and lesion detection/conspicuity in the liver. For this study, it is hypothesized that dynamic imaging using Gadopiclenol is noninferior to gadoxetate MRI in terms of image quality and lesion detection/conspicuity.
- Conditions
- Liver Lesion
- Being tested
- Radiology, Gadopiclenol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiologyOther
Radiology - MRI Scans
GadopiclenolOther
Gadopiclenol is a new macrocyclic gadolinium-based contrast agent (GBCA)
| Study group | Role | What they receive |
|---|---|---|
| Liver | Patients who have had clinically indicated MRI scans for liver lesions. Receives: Other: Radiology; Other: Gadopiclenol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion Detection
Lesion detection (for any enhancing lesions including benign and malignant lesions, excluding cysts and completely necrotic treated malignant lesions) will be evaluated both for gadopiclenol-enhanced study (including unenhanced sequences from index MRI) and gadoxetate-enhanced MRI (the reference standard method): will be classified for each post- contrast phase as 0: no visible enhancing lesion, 1: visible enhancing lesion.
Measured: End of study, at 6 months
Secondary outcomes (1)
Liver lesion conspicuity
Liver lesion conspicuity (detected on full protocol clinical MRI scan) will be assessed for each postcontrast phase using the following scores: 0, not seen; 1: barely conspicuous; 2: fairly well seen; 3: moderately well seen; 4: well seen; and 5: very well seen. Each lesion will be delineated on Couinaud segmental maps.
Measured: End of study, at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jul 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver LesionStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Guerbet
- Responsible party
- Principal investigator, Sara Lewis, Icahn School of Medicine at Mount Sinai
- Investigators
- Sara Lewis, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596616
- Sponsor's protocol ID
- GCO 23-1475
- Status last verified
- Apr 2026
- First submitted
- 11 Sep 2024
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not within the scope the study
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR Image Quality and Liver Lesion Detection With Gadopiclenol: Comparison With Gadoxetate Disodium
- ClinicalTrials.gov ID
- NCT06596616
- Acronym / sponsor ID
- GCO 23-1475
- Conditions
- Liver Lesion
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Guerbet
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 19 Sep 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 overall purpose of this study is to establish noninferiority of gadopiclenol MRI compared to gadoxetate MRI in terms of image quality and lesion detection/conspicuity in patients undergoing clinically indicated liver MRI in a prospective study. The research will be utilizing MRI; with enrollment goal of 75 subjects over the course of two years.
Detailed description
Gadopiclenol is a new macrocyclic gadolinium-based contrast agent (GBCA) which has higher relaxivity than other GBCAs with a potential use of lower dose and comparable pharmacokinetics to other agents in preclinical studies. In a rodent model of liver metastasis, gadopiclenol showed strong enhancement with comparable pharmacokinetics to other extracellular GBCAs (EC-GBCAs). It was found to have a potential of either improving lesion conspicuity or providing similar accuracy in lesion detection with a reduced Gadolinium (Gd) dose. In a rat brain tumor model, half dose (0.05 mmol/kg) of gadopiclenol yielded comparable contrast-to-noise ratio (CNR) and morphological characterization of brain tumors compared to other EC-GBCAs. There are also a few clinical studies in which no safety concern was raised with the use of gadopiclenol. No dose adjustment for children or patients with renal impairment was found to be required. There is no study in the literature assessing the enhancement properties of gadopiclenol in abdominal imaging and comparing it with a hepatobiliary agent for image quality and lesion detection/conspicuity in the liver. For this study, it is hypothesized that dynamic imaging using Gadopiclenol is noninferior to gadoxetate MRI in terms of image quality and lesion detection/conspicuity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver | – | Other: Radiology, Other: GadopiclenolPatients who have had clinically indicated MRI scans for liver lesions. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with undergoing MRI for management of chronic liver disease, liver lesions, and/or tumor treatment follow up
Key inclusion criteria (1 listed)
- Adult patients of both genders and all ethnic groups with clinical indication of MRI for chronic liver disease and/or focal lesion and/or tumor treatment follow-up.
Key exclusion criteria (5 listed)
- Acute renal insufficiency.
- Severe chronic renal insufficiency (GFR <30 mL/min/1.73 m2).
- Age <18y.
- Unable or unwilling to give informed consent.
- Contraindications for MRI (such as pacemakers, infusion pumps, pregnancy, allergy or previous adverse reactions to gadolinium contrast agents, severe claustrophobia).
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 |
|---|---|---|
| RadiologyRadiology - MRI Scans | Other | Liver |
| GadopiclenolGadopiclenol is a new macrocyclic gadolinium-based contrast agent (GBCA) | Other | Liver |
Primary outcome
Lesion Detection
Time frame: End of study, at 6 months
Lesion detection (for any enhancing lesions including benign and malignant lesions, excluding cysts and completely necrotic treated malignant lesions) will be evaluated both for gadopiclenol-enhanced study (including unenhanced sequences from index MRI) and gadoxetate-enhanced MRI (the reference standard method): will be classified for each post- contrast phase as 0: no visible enhancing lesion, 1: visible enhancing lesion.
1 secondary outcome
Liver lesion conspicuity
Time frame: End of study, at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No. Not within the scope the study
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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.
Sara Lewis, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Lesion, run by Icahn School of Medicine at Mount Sinai 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 1 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: enrolling by invitation, as of the sponsor's last update on 22 Apr 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Lesion Detection (time frame: End of study, at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2026.