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Lymphangioma clinical trials

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NCT ID: NCT06437158 Recruiting - Clinical trials for Lymphatic Malformation

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

Start date: March 8, 2023
Phase: Phase 2
Study type: Interventional

Bleomycin has nowadays been more and more widely used in the sclerotherapy of LMs, which has been proven to be primarily dose dependent. The investigators aim to compare the efficacy and safety of different concentrations of Bleomycin in the sclerotherapy of LMs for pediatric patients.

NCT ID: NCT06275022 Recruiting - Clinical trials for Lymphatic Malformation

A Prospective Study on the Treatment of cLM Based on ICG Imaging

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

The goal of this prospective randomized controlled study is to explore the role of indocyanine green-fluorescence imaging in management of cystic lymphatic malformation.. To clarify the application value of indocyanine green-fluorescence imaging in both diagnosis and treatment of cystic lymphatic malformation (cLM) in children, is helpful for exploring pathogenesis of cLM, and providing a clearer scientific basis for subsequent surgical intervention. It also provides alternative for the future diagnosis and treatment of cLM. Participants will receive indocyanine green-fluorescence imaging before operation, while the patients in control group will receive traditional operation. Researchers will compare difference in curative effect between two groups.

NCT ID: NCT06257719 Completed - Clinical trials for Lymphatic Malformation

Clinical Characteristics of Lymphatic Malformations

Start date: January 2009
Phase:
Study type: Observational

The primary purpose of this study is to retrospectively identify the clinical characteristics of abdominal lymphatic malformations (ALMs) in our single center in China. The second objective of this study is to retrospectively compare the epidemiological features, clinical presentations, cyst properties, surgical treatments, and risk factors for preoperative complications of ALMs between paediatric participants and adult participants.

NCT ID: NCT06239480 Not yet recruiting - Clinical trials for Microcystic Lymphatic Malformation

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations

SELVA
Start date: July 2024
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to assess the change in clinician global impression after 24 weeks of treatment with QTORIN 3.9% Rapamycin Anhydrous Gel compared to placebo in approximately 50 participants with microcystic lymphatic malformations.

NCT ID: NCT06160739 Recruiting - Clinical trials for Vascular Malformations

Role of Sirolimus in Treatment of Microcystic , Mixed Lymphatic and Vascular Malformations

Start date: November 20, 2023
Phase:
Study type: Observational

Lympho-vascular malformations result from errors in embryologic vasculogenesis involving capillaries, veins, arteries, lymphatics, or a combination of these. Infantile haemangiomas & Vascular malformations like : Capillary malformations & Venous malformations : they increase in size and never regress on their own. & They are generally present at birth, they enlarge in response to infection, hormonal changes or trauma . Lymphatic malformations can be classified into macrocystic (cyst diameter >1cm), microcystic (cyst diameter <1 cm), or mixed , in macrocystic lymphatic malformations, surgery and sclerotherapy are effective . Surgery of microcystic lymphatic malformations remains challenging due to their infiltrative nature & Sclerotherapy is often impossible. As especially large microcystic and mixed malformations are still a therapeutic challenge, pharmaceutical treatment as sirolimus is used in last years as main line of treatment with great efficacy.

NCT ID: NCT05983159 Not yet recruiting - Clinical trials for Arteriovenous Malformations

A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations

TARGET-VM
Start date: August 2024
Phase: Phase 2
Study type: Interventional

Recent studies have demonstrated that growth of vascular malformations can be driven by genetic variants in one of 2 signalling pathways. Targeted drugs specific to these pathways have been developed and shown to be effective in treating cancer. This study will describe the effectiveness of (i) 48 weeks of alpelisib therapy for participants with slow-flow vascular malformations and a gene mutation in one of these signalling pathways (module 1) and (ii) 48 weeks of mirdametinib therapy for participants with fast-flow vascular malformations and a gene mutations in the other signalling pathway (module 2).

NCT ID: NCT05948943 Recruiting - Clinical trials for Lymphatic Malformations

Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.

EPIK-L1
Start date: November 24, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The main purpose of this study in participants with PIK3CA-mutated lymphatic malformations (LyM) is to assess the change in radiological response and symptom severity upon treatment with alpelisib as compared to placebo.

NCT ID: NCT05871970 Recruiting - Clinical trials for Lymphatic Malformation

Safety and Efficacy Study of Intracystic TARA-002 for the Treatment of Lymphatic Malformations in Participants 6 Months to Less Than 18 Years of Age

STARBORN-1
Start date: October 18, 2023
Phase: Phase 2
Study type: Interventional

This is a Phase 2a/b single arm open label study to evaluate the safety, reactogenicity, and efficacy of intracystic injection of TARA-002 in participants 6 months to less than 18 years of age for the treatment of macrocystic and mixed cystic lymphatic malformations. The Phase 2a safety lead-in, age de-escalation study is designed to establish the safety of TARA-002 in older participants 6 years to less than 18 years before proceeding to younger participants 2 years to less than 6 years, then 6 months to less than 2 years. The Phase 2b is an expansion study in which enrollment of participants will be initiated after safety has been established in each cohort during the Phase 2a safety lead-in study. Each participant will receive up to 4 injections of TARA-002 spaced approximately 6 weeks apart.

NCT ID: NCT05563831 Recruiting - Clinical trials for Vascular Malformations

National Evaluation of Patients With PIK3CA-Related Overgrowth Spectrum (PROS)

COSY
Start date: February 21, 2023
Phase:
Study type: Observational

Overgrowth syndromes are rare genetic disorders defined by tissue hypertrophy that can be either localized or generalized, affecting both latitudinal and longitudinal growth. The genes involved in overgrowth syndromes are not well characterized but mostly concern the PIK3CA/AKT/mTOR pathway, a major actor of cell growth and proliferation. The mutations are not inherited but occurs during embryogenesis leading to somatic mosaicism. Owing to the variability of the clinical presentation, their exact prevalence is yet unknown. In order to answer this question, the investigators team create here the first French national registry on overgrowth syndromes.

NCT ID: NCT05050149 Recruiting - Clinical trials for Microcystic Lymphatic Malformation

Study Evaluating the Safety and Efficacy of PTX-022 (QTORIN Sirolimus) in the Treatment of Microcystic Lymphatic Malformations

Start date: September 15, 2021
Phase: Phase 2
Study type: Interventional

This study evaluates the safety and efficacy of PTX-022 (sirolimus) Topical Gel 3.9% w/w in the treatment of Microcystic Lymphatic Malformations. The participant will receive 3 months of PTX-022 treatment by the end of the study.