---
title: Gadopiclenol vs Gadoxetate MRI for Liver Lesions
nct_id: NCT06596616
overall_status: ENROLLING_BY_INVITATION
sponsor: Icahn School of Medicine at Mount Sinai
study_type: OBSERVATIONAL
primary_condition: Liver Lesion
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06596616.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06596616"
ct_last_update_post_date: 2026-04-22
last_seen_at: "2026-05-12T06:40:20.513Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Gadopiclenol vs Gadoxetate MRI for Liver Lesions

**Official Title:** MR Image Quality and Liver Lesion Detection With Gadopiclenol: Comparison With Gadoxetate Disodium

**NCT ID:** [NCT06596616](https://clinicaltrials.gov/study/NCT06596616)

## Key Facts

- **Status:** ENROLLING_BY_INVITATION
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 23
- **Lead Sponsor:** Icahn School of Medicine at Mount Sinai
- **Collaborators:** Guerbet
- **Conditions:** Liver Lesion
- **Start Date:** 2024-07-01
- **Completion Date:** 2027-01
- **CT.gov Last Update:** 2026-04-22

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 89 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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).
```

## Arms

- **Liver** — Patients who have had clinically indicated MRI scans for liver lesions.

## Interventions

- **Radiology** (OTHER) — Radiology - MRI Scans
- **Gadopiclenol** (OTHER) — Gadopiclenol is a new macrocyclic gadolinium-based contrast agent (GBCA)

## Primary Outcomes

- **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.

## Secondary Outcomes

- **Liver lesion conspicuity** _(time frame: End of study, at 6 months)_

## Locations (1)

- BMEII, New York, New York, United States

## Recent Field Changes (last 30 days)

- `results.hasResults` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `locations.bmeii|new york|new york|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT06596616*  
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