Actively Recruiting

Phase Not Applicable
Age: 30Days - 16Years
All Genders
ID06275022

A Prospective Randomized Controlled Study on the Treatment of Cystic Lymphatic Malformation Based on Indocyanine Green-fluorescence Imaging

Led by Nanjing Children's Hospital · Updated on 2026-02-18

110

Participants Needed

1

Research Sites

1 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to explore the role of indocyanine green-fluorescence imaging in diagnosing and treating cystic lymphatic malformation (cLM) in children. The study will compare this imaging approach with traditional surgical methods to provide clearer scientific evidence for future treatments and better understand the disease's development. Participants are divided into groups receiving different treatments, including inflow occlusion assisted by indocyanine green-fluorescence imaging combined with perforation of septation and sclerotherapy, perforation of septation and sclerotherapy alone, indocyanine green-guided partial resection and sclerotherapy, or partial resection and sclerotherapy. Those in the imaging groups receive special guidance during surgery using the indocyanine green method, while control groups receive traditional methods. During the study, researchers will evaluate cure rates and treatment effectiveness at one and three months after treatment, along with how often treatments are needed over six months. Secondary outcomes include wound infection, delayed healing, pigmentation, and patient scores six months post-treatment. Participants will be followed for three to six months to monitor results and side effects.

CONDITIONS

Brief Title

A Prospective Study on the Treatment of cLM Based on ICG Imaging

Who Can Participate

Age: 30Days - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • No previous intervention for cystic lymphatic malformation
  • Diagnosed with cystic lymphatic malformation by pretreatment MRI
  • Willing to complete 3 to 6 months post-treatment follow-up
  • Superficial cystic lymphatic malformation
Not Eligible

You will not qualify if you...

  • History of iodine allergy
  • Syndromic cystic lymphatic malformation
  • Severe liver or kidney dysfunction
  • Intralesional hemorrhage
  • Intralesional infection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 6 months depending on treatment frequency

Participants receive one of several procedures involving indocyanine green-fluorescence imaging and sclerotherapy to treat cystic lymphatic malformation.

Visits occur as needed for treatment sessions and assessments over 3 to 6 months

Trial Site Locations

Total: 1 location

1

Children's hospital of Nanjing medical university

Nanjing, Jiangsu, China, 210008

Actively Recruiting

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Research Team

T

Tao Han, Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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