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Evaluation of Lung Metastases Based on Ultrashort Echo Time MRI

Sponsor
RenJi Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05763173
Collaborator
(none)
60
Enrollment
1
Location
7
Anticipated Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    The Diagnostic Value of Lung Ultrashort Echo Time MRI for Potential Lung Metastases in Children With Hepatoblastoma
    Anticipated Study Start Date :
    Mar 1, 2023
    Anticipated Primary Completion Date :
    Oct 1, 2023
    Anticipated Study Completion Date :
    Oct 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. UTE-MRI assessment of lung metastases with chest CT as gold standard [Baseline to 14 days]

      Analyze the diagnostic efficiency (including performance, diameter, and location of nodules) of UTE-MRI in lung metastases of hepatoblastoma.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 14 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Radiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University Shanghai Shanghai China 200127

    Sponsors and Collaborators

    • RenJi Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT05763173
    Other Study ID Numbers:
    • LY2022-064-B
    First Posted:
    Mar 10, 2023
    Last Update Posted:
    Mar 10, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hepatoblastoma

    Study Results

    No Results Posted as of Mar 10, 2023