Use of Bleomycin in the Sclerotherapy of Lymphatic Malformations for Pediatric Patients

Launched by WEST CHINA HOSPITAL · May 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called Bleomycin for treating lymphatic malformations (LMs) in children. LMs are abnormal growths in the lymphatic system, which can cause swelling and other problems. The researchers want to find out which concentration of Bleomycin is the most effective and safe for this type of treatment. They are currently looking for participants who are under 14 years old, have parents willing to give consent, and have LMs that are causing noticeable symptoms or issues and can't be easily removed with surgery.

If your child is eligible and chooses to participate, they will receive Bleomycin through a procedure called sclerotherapy, which involves injecting the medication into the affected area to help shrink the malformation. The trial is still recruiting participants, so if you think your child might benefit, it's a good idea to discuss it with your healthcare provider to learn more.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female participants less than 14 years of age at the time of informed consent/assent form was signed.
• • Participants whose parents have voluntarily given written consent and participants who provided assent (if applicable) after the study has been explained to them.
• • Participants with LMs of all sites measured and confirmed via imaging at screening, with rapid progression, resluting in obvious symptoms or dysfunction, which could not be radically resected and could be treated by sclerotherapy.
• Exclusion Criteria:
• • Penicillin allergy.
• • Vascular tumors or combined vascular malformations.
• • Participants who may have had surgical or sclerotherapy treatment by other hardeners.
• • LMs growing slowly, without obvious symptoms or dysfunction, which does not need to be treated prematurely.