Using indocyanine green imaging to treat cystic lymphatic malformation in children
A Prospective Randomized Controlled Study on the Treatment of Cystic Lymphatic Malformation Based on Indocyanine Green-fluorescence Imaging
This study tests if using a special imaging technique can help doctors treat cystic lymphatic malformation in children better than traditional surgery alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 30 Days to 16 Years |
| Sex | All |
| Sponsor | Nanjing Children's Hospital Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06275022 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of indocyanine green-fluorescence imaging in the management of cystic lymphatic malformation (cLM) in children. Participants will undergo imaging before surgery, while a control group will receive traditional surgical methods. The study will compare the outcomes of both approaches to determine the potential benefits of using this imaging technique in diagnosis and treatment. The findings could enhance understanding of cLM and improve surgical interventions.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 6 months diagnosed with superficial cystic lymphatic malformation who have not undergone previous interventions.
Not a fit: Patients with a history of iodine allergy, syndromic cLM, or severe liver and kidney dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and targeted treatments for children with cystic lymphatic malformation.
How similar studies have performed: While the use of indocyanine green imaging is gaining traction, this specific application in treating cLM is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: (1) no previous intervention; (2) cLM diagnosed by pretreatment magnetic resonance imaging (MRI); (3)3 to 6 months post-treatment follow-up; (4) Superfacial cLM Exclusion Criteria: (1) history of iodine allergy; (2) syndromic cLM ; (3) severe liver and kidney dysfunction; (4) intralesional hemorrhage; (5) intralesional infection
Where this trial is running
Nanjing, Jiangsu
- Children's hospital of Nanjing medical university — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Tao Han, Dr.
- Email: dr.hantao@njmu.edu.cn
- Phone: +86 186 5190 3495
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.