Lymphatic MalformationNCT06755905
Indocyanine Green Lymphography in Management of Lingual Lymphatic Malformation
A study testing ICGL-guided treatment and Conventional Treatment group in people with Lymphatic Malformation, run by Nanjing Children's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Lymphatic Malformation
- What is being tested?
- ICGL-guided treatment and Conventional Treatment group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- No previous intervention
- more than 6 months post-treatment follow-up
- Stage I or Stage IIa
Who cannot join
- History of iodine allergy
- Syndromic cLM
- Severe liver and kidney dysfunction
Trial locations and contacts
1 site in 1 country.
China1 site
Children's hospital of nanjing medical university
Nanjing, Jiangsu, 210008
About this study
Official title: 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.
- Conditions
- Lymphatic Malformation
- Being tested
- ICGL-guided treatment, Conventional Treatment group
- Keywords
- indocyanine green, tongue, Lymphatic Malformation
- Medical subject headings
- Lymphatic Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICGL-guided treatmentProcedure or surgery
Indocyanine green lymphography guided resection combined with sclerotherapy
Conventional Treatment groupProcedure or surgery
Resection with sclerotherapy
| Study group | Role | What they receive |
|---|---|---|
| lingual LM with ICGL-guided treatment | Experimental | indocyanine green lymphography guided resection combined with sclerotherapy Receives: Procedure: ICGL-guided treatment |
| Conventional treatment | Active comparator | lingual LM with conventional treatment Receives: Procedure: Conventional Treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cured (Reduction in dimension greater than 90%)
Reduction in dimension greater than 90%
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start1 Jan 2019
- Primary completion30 Jun 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphatic MalformationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Han, Nanjing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755905
- Sponsor's protocol ID
- NanjingCH0116651
- Status last verified
- Mar 2025
- First submitted
- 19 Dec 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40660315
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Value of Indocyanine Green Lymphography in Management of Microcystic Lymphatic Malformation of the Tongue
- ClinicalTrials.gov ID
- NCT06755905
- Acronym / sponsor ID
- NanjingCH0116651
- Conditions
- Lymphatic Malformation
- Keywords
- indocyanine green, tongue, Lymphatic Malformation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Nanjing Children's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lingual LM with ICGL-guided treatment | Experimental | Procedure: ICGL-guided treatmentindocyanine green lymphography guided resection combined with sclerotherapy |
| Conventional treatment | Active comparator | Procedure: Conventional Treatment grouplingual LM with conventional treatment |
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- No previous intervention
- more than 6 months post-treatment follow-up
- Stage I or Stage IIa
Key exclusion criteria (3 listed)
- History of iodine allergy
- Syndromic cLM
- Severe liver and kidney dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICGL-guided treatmentIndocyanine green lymphography guided resection combined with sclerotherapy | Procedure or surgery | lingual LM with ICGL-guided treatment |
| Conventional Treatment groupResection with sclerotherapy | Procedure or surgery | Conventional treatment |
Primary outcome
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%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Derived from this study: PubMed 40660315Han 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICGL-guided treatment and Conventional Treatment group in people with Lymphatic Malformation, run by Nanjing Children's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cured (Reduction in dimension greater than 90%) (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06755905, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.