Evaluation of Lung Metastases Based on Ultrashort Echo Time MRI

NCT05763173 | Completed

• 1 other identifier: LY2022-064-B
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hepatoblastoma; Radiology

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children diagnosed as hepatoblastoma

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Department of Radiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Hepatoblastoma

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 10, 2023
• Study Start: January 1, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

CN (1)