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Lymphatic Magnetic Resonance Imaging Abnormalities in Children With Tetralogy of Fallot: A Case-Control Study

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT06097377
Collaborator
(none)
10
Enrollment
1
Location
22
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study examines subclinical lymphatic abnormalities in Tetralogy of Fallot patients, utilizing lymphatic magnetic resonance and near-infrared fluorescence imaging.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    10 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Lymphatic Magnetic Resonance Imaging Abnormalities in Children With Tetralogy of Fallot: A Case-Control Study
    Actual Study Start Date :
    Nov 1, 2021
    Actual Primary Completion Date :
    Sep 1, 2023
    Actual Study Completion Date :
    Sep 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    ToF
    Controls

    Outcome Measures

    Primary Outcome Measures

    1. Lymphatic abnormalities [During scan]

      MRI assessed lymphatic abnormalities

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 18 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • ToF
    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rigshospitalet København Ø Denmark 2100

    Sponsors and Collaborators

    • Rigshospitalet, Denmark

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vibeke Brix Christensen, MD, DMSc, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT06097377
    Other Study ID Numbers:
    • Lymphatic Magnetic Resonance
    First Posted:
    Oct 24, 2023
    Last Update Posted:
    Oct 24, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Tetralogy of Fallot

    Study Results

    No Results Posted as of Oct 24, 2023