Clinical trial NCT06596616: Gadopiclenol vs Gadoxetate MRI for Liver Lesions
Official title: MR Image Quality and Liver Lesion Detection With Gadopiclenol: Comparison With Gadoxetate Disodium
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Lesion
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Guerbet
First posted: 2024-09-19
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with undergoing MRI for management of chronic liver disease, liver lesions, and/or tumor treatment follow up

Brief 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. 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.

Eligibility criteria: Inclusion criteria:

• 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.

Exclusion criteria:

* 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).

Primary outcomes:
measure: Lesion Detection
timeFrame: End of study, at 6 months
Secondary outcomes:
measure: Liver lesion conspicuity
timeFrame: End of study, at 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: BMEII
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Sara Lewis, MD
role: PRINCIPAL_INVESTIGATOR
References: