NCT06755905

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 1, 2025

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

5.5 years

First QC Date

December 19, 2024

Last Update Submit

March 12, 2025

Conditions

Lymphatic Malformation

Keywords

indocyanine greentongueLymphatic Malformation

Outcome Measures

Primary Outcomes (1)

  • Cured (Reduction in dimension greater than 90%)

    Reduction in dimension greater than 90%

    From enrollment to the end of treatment at 12 weeks

Study Arms (2)

lingual LM with ICGL-guided treatment

EXPERIMENTAL

indocyanine green lymphography guided resection combined with sclerotherapy

Procedure: ICGL-guided treatment

Conventional treatment

ACTIVE COMPARATOR

lingual LM with conventional treatment

Procedure: Conventional Treatment group

Interventions

ICGL-guided treatmentPROCEDURE

Indocyanine green lymphography guided resection combined with sclerotherapy

lingual LM with ICGL-guided treatment
Conventional Treatment groupPROCEDURE

Resection with sclerotherapy

Conventional treatment

Eligibility Criteria

AgeUp to 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's hospital of nanjing medical university

Nanjing, Jiangsu, 210008, China

Location

Related Publications (1)

  • Han T, Shi L, Huang S, Shen W. Application value of indocyanine green lymphography in the management of stage I/IIA microcystic lymphatic malformation of the tongue. Head Face Med. 2025 Jul 14;21(1):51. doi: 10.1186/s13005-025-00529-2.

    PMID: 40660315DERIVED

MeSH Terms

Conditions

Lymphatic Abnormalities

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 19, 2024

First Posted

January 1, 2025

Study Start

January 1, 2019

Primary Completion

June 30, 2024

Study Completion

December 15, 2024

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)