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NCT05763173 Clinical Trial

Evaluation of Lung Metastases Based on Ultrashort Echo Time MRI

Hepatoblastoma Clinical Trial

Official title:
The Diagnostic Value of Lung Ultrashort Echo Time MRI for Potential Lung Metastases in Children With Hepatoblastoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05763173
Other study ID # LY2022-064-B
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date February 29, 2024

Study information
Verified date April 2024
Source RenJi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Analyze the diagnostic efficiency (including performance, diameter, and location of nodules) of UTE-MRI in lung metastases of hepatoblastoma with chest CT as gold standard

Recruitment information / eligibility
Status Completed
Enrollment 65
Est. completion date February 29, 2024
Est. primary completion date February 29, 2024
Accepts healthy volunteers
Gender All
Age group N/A to 14 Years
Eligibility Inclusion Criteria: - Children diagnosed as hepatoblastoma (including treated with neoadjuvant chemotherapy but not surgery) - Recent chest CT scan (within 14 days) - No MRI contraindications - The guardian of the children are willing to undergo the examination after full communication and informed consent Exclusion Criteria: - MRI contraindications (including but not limited to: contrast medium allergy; Claustrophobia;Metal implants;chronic kidney disease=stage 3 (glomerular filtration rate < 60 mL min-1 (1.73 m2)-1)) - Patients with hepatoblastoma aged 14 years and above - Children after surgery for hepatoblastoma - Application of any contrast medium within 24 h before the MRI and/or CT examinations - There is a concomitant medical condition (e.g. poorly controlled hypertension, severe diabetes, neurological or psychiatric illness, etc.) or any other condition that would seriously endangers the subject's safety, may confuse the study results, or may interfere with the subject's completion of the study according to the investigator's judgment.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Department of Radiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary UTE-MRI assessment of lung metastases with chest CT as gold standard Analyze the diagnostic efficiency (including performance, diameter, and location of nodules) of UTE-MRI in lung metastases of hepatoblastoma. Baseline to 14 days
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