Evaluation of Lung Metastases Based on Ultrashort Echo Time MRI

April 16, 2024 updated by: RenJi Hospital

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Department of Radiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 14 years (Child)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Children diagnosed as hepatoblastoma

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

February 29, 2024

Study Completion (Actual)

February 29, 2024

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 10, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY2022-064-B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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