Indocyanine Green Lymphography in Management of Lingual Lymphatic Malformation

March 12, 2025 updated by: Tao Han, Nanjing Children's Hospital

Application Value of Indocyanine Green Lymphography in Management of Microcystic Lymphatic Malformation of the Tongue

To elucidate the application of indocyanine green (ICG) fluorescence angiography in the treatment of childhood tongue cLM (clinically localized malignancy, presumed context here), providing a clearer scientific basis for subsequent targeted interventions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

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
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Children's Hospital of Nanjing Medical 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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • No previous intervention
  • more than 6 months post-treatment follow-up
  • Stage I or Stage IIa

Exclusion Criteria:

  • History of iodine allergy
  • Syndromic cLM
  • Severe liver and kidney dysfunction

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lingual LM with ICGL-guided treatment
indocyanine green lymphography guided resection combined with sclerotherapy
Procedure: ICGL-guided treatment
Indocyanine green lymphography guided resection combined with sclerotherapy
Active Comparator: Conventional treatment
lingual LM with conventional treatment
Procedure: Conventional Treatment group
Resection with sclerotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cured (Reduction in dimension greater than 90%)
Time Frame: From enrollment to the end of treatment at 12 weeks
Reduction in dimension greater than 90%
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

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

Sponsor

Nanjing Children's 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, 2019

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

December 15, 2024

Study Registration Dates

First Submitted

December 19, 2024

First Submitted That Met QC Criteria

December 31, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 12, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NanjingCH0116651

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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