Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639828
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Phase 4 Paediatric Study to Evaluate Sonazoid Safety and Efficacy for Contrast-Enhanced Ultrasound Liver Imaging
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 4 Open-Label Non-randomised Multicentre Study to Evaluate Safety and Efficacy of Intravenous Administration of Sonazoid for Contrast-Enhanced Ultrasound Liver Imaging in Paediatric Patients
Status:
RECRUITING
Status Verified Date:
2024-10
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:
Liver tumours 40 of which are benign account for 1 to 4 of all solid tumours in children The benign tumours are mainly haemangiomas liver hamartomas and liver cell adenomas The malignant tumours are mainly hepatoblastoma hepatocellular carcinoma HCC malignant liver mesothelioma and rhabdomyosarcoma The differential diagnosis of liver masses in children is generally based on the childs age the clinical evaluation including alpha-fetoprotein test results and imaging characteristics
Liver tumours seldom produce clear symptoms and signs in the early stages and they progress rapidly As a result most liver tumours are not diagnosed until the middle or late stages To improve survival among patients with liver tumours clinicians must find the liver tumours as early as possible and determine whether the tumours are benign or malignant Conventional ultrasonography is commonly used for screening and is preferred as the first-line imaging technique for children Not only does it have a wide range of applications and a high diagnostic yield but it is well accepted by patients and their parents It can be performed in the examination room with the parents present allowing real-time imaging and direct interaction with patient and parents
CEUS is a non-invasive imaging technology that can continuously and dynamically observe blood perfusion in tumours in real-time through injection of a contrast agent to enhance the blood flow reflux signal in the human body Consequently CEUS is useful for visualising capillaries and tissue perfusion in the human body
The purpose of this current study is to evaluate the use of Sonazoid perfluorobutane PFB microbubbles as a contrast medium for CEUS for evaluation of solitary liver masses in children
Liver tumours seldom produce clear symptoms and signs in the early stages and they progress rapidly As a result most liver tumours are not diagnosed until the middle or late stages To improve survival among patients with liver tumours clinicians must find the liver tumours as early as possible and determine whether the tumours are benign or malignant Conventional ultrasonography is commonly used for screening and is preferred as the first-line imaging technique for children Not only does it have a wide range of applications and a high diagnostic yield but it is well accepted by patients and their parents It can be performed in the examination room with the parents present allowing real-time imaging and direct interaction with patient and parents
CEUS is a non-invasive imaging technology that can continuously and dynamically observe blood perfusion in tumours in real-time through injection of a contrast agent to enhance the blood flow reflux signal in the human body Consequently CEUS is useful for visualising capillaries and tissue perfusion in the human body
The purpose of this current study is to evaluate the use of Sonazoid perfluorobutane PFB microbubbles as a contrast medium for CEUS for evaluation of solitary liver masses in children
Detailed Description:
This Phase 4 open-label non-randomised multicentre prospective study in Europe will enrol paediatric patients who are presenting with 1 confirmed untreated target FLL This study plans to enrol at least 50 subjects at up to 12 centres in Europe If a patient has multiple FLLs the Investigator must select the target lesion at their discretion Where possible the target lesion should be a clearly visible and accessible lesion that could be easily followed during the non-CE ultrasound examination and all phases of the CEUS examination The reference diagnosisstandard of truth for the target lesion of interest will be established by the principal investigatorssub-investigators on the basis of all available clinical information including the results of biopsy if available and the dynamic CECT or CEMRI examination required for the study
Following unenhanced pre-contrast ultrasound imaging of the target FLL a single dose of Sonazoid dosed according to body weight 012 μL microbubbleskg will be intravenously administered to each patient and a CEUS examination will be performed with images acquired as specified in the Imaging Manual
The unenhanced ultrasound and CEUS images will be assessed by 3 independent blinded readers following WFUMB-EFSUMB guidelines for adults and in accordance with the Independent Review Charter The diagnoses based on the unenhanced ultrasound and the CEUS results will be compared with the reference diagnosisstandard of truth for the target lesion The diagnostic accuracy sensitivity and specificity of the unenhanced ultrasound and CEUS images will then be calculated Clinical safety data will be collected throughout the study Safety will be evaluated by monitoring subjects for the occurrence of AEs
Following unenhanced pre-contrast ultrasound imaging of the target FLL a single dose of Sonazoid dosed according to body weight 012 μL microbubbleskg will be intravenously administered to each patient and a CEUS examination will be performed with images acquired as specified in the Imaging Manual
The unenhanced ultrasound and CEUS images will be assessed by 3 independent blinded readers following WFUMB-EFSUMB guidelines for adults and in accordance with the Independent Review Charter The diagnoses based on the unenhanced ultrasound and the CEUS results will be compared with the reference diagnosisstandard of truth for the target lesion The diagnostic accuracy sensitivity and specificity of the unenhanced ultrasound and CEUS images will then be calculated Clinical safety data will be collected throughout the study Safety will be evaluated by monitoring subjects for the occurrence of AEs
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