ClinicalTrials.gg
CompletedNCT06755905Updated Mar 13, 2025

Indocyanine Green Lymphography in Management of Lingual Lymphatic Malformation

An interventional study of ICGL-guided treatment and Conventional Treatment group in Lymphatic Malformation, sponsored by Nanjing Children's Hospital. Completed at 1 site in China. Open to participants aged Up to 14 Years. Per ClinicalTrials.gov, last updated 2025-03-13.

Sponsored by Nanjing Children's Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 11 months after the study started (first participant enrolled Jan 2019, registered Dec 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
Up to 14 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Lymphatic Malformation

Keywords

  • indocyanine green
  • tongue
  • Lymphatic Malformation
03

In context

Lymphatic Abnormalities

42 studies on the registry are indexed under Lymphatic Abnormalities; 17 are open to participants now.

This study's enrollment of 42 is close to the median of 46 across 28 interventional studies indexed under Lymphatic Abnormalities.

Browse Lymphatic Abnormalities studies →

Lead sponsor

Nanjing Children's Hospital is the lead sponsor of 16 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • History of iodine allergy
  • Syndromic cLM
  • Severe liver and kidney dysfunction
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    lingual LM with ICGL-guided treatment

    indocyanine green lymphography guided resection combined with sclerotherapy

    Procedure: ICGL-guided treatment

  • Active comparator
    Conventional treatment

    lingual LM with conventional treatment

    Procedure: Conventional Treatment group

Interventions

  • ProcedureICGL-guided treatment

    Indocyanine green lymphography guided resection combined with sclerotherapy

  • ProcedureConventional Treatment group

    Resection with sclerotherapy

06

What researchers measure

Primary outcomes

  1. Cured (Reduction in dimension greater than 90%)

    Reduction in dimension greater than 90%

    Time frame: From enrollment to the end of treatment at 12 weeks

07

Study locations

1 site
  • Children's hospital of nanjing medical university
    Nanjing, Jiangsu 210008, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06755905
Lead sponsor
Nanjing Children's Hospital
Responsible party
Tao Han (Clinical Professor, Nanjing Children's Hospital) — Principal investigator
First posted
Jan 1, 2025
Start date
Jan 1, 2019
Primary completion
Jun 30, 2024
Completion
Dec 15, 2024
Last update
Mar 13, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion