Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596616
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Comparison with EOB
Sponsor:
None
Organization:
None
Study Overview
Official Title:
MR Image Quality and Liver Lesion Detection with Gadopiclenol Comparison with Gadoxetate Disodium
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 detectionconspicuity 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 005 mmolkg 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 detectionconspicuity 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 detectionconspicuity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None