Clinical trials: Lymphatic Malformation, open to volunteers
Lymphatic Malformations
Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.
The main purpose of this study in participants with PIK3CA-mutated LyM is to assess the change in radiological response and symptom severity upon treatment with alpelisib film-coated tablets (FCT) as compared to placebo.
- Trial name
- EPIK-L1 (NCT05948943)
- Testing
- Alpelisib
- Where
- 61 sites in United States, Argentina and 10 more
- Volunteers
- 232 people
- Sponsor
- Novartis Pharmaceuticals
Venous Malformations, Lymphatic Malformations
A Study to Investigate Efficacy and Safety of KP-001 Compared With Placebo in Patients Aged ≥2 Years With Common VM, Common LM, or KTS/CLOVES Syndrome
This is a phase 3, double-blind, randomized, placebo-controlled, parallel group, adaptive, multicenter study planned to be conducted at multiple sites in North America, Canada, Taiwan and South Korea.
- Conditions
- Venous Malformations, Lymphatic Malformations, Klippel-Trenaunay Syndrome, CLOVES Syndrome
- Trial name
- S-KY (NCT07285005)
- Testing
- KP-001
- Where
- 5 sites in United States, South Korea and 1 more
- Volunteers
- 150 people
- Sponsor
- Kaken Pharmaceutical
Lymphatic Malformation, Generalized Lymphatic Anomaly (GLA)
Lymphatic Anomalies Registry for the Assessment of Outcome Data
Lymphatic anomalies are a rare subset of vascular anomalies that are poorly understood. the understanding of the natural history, long-term outcomes, risk factors for morbidity and mortality, and the relative benefit of medical…
- Conditions
- Lymphatic Malformation, Generalized Lymphatic Anomaly (GLA), Central Conducting Lymphatic Anomaly, CLOVES Syndrome
- Trial name
- NCT02399527
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Boston Children's Hospital
PIK3CA-Related Overgrowth Spectrum (PROS), Lymphatic Malformations
A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, in Adults and Children With PIK3CA Related Overgrowth Spectrum and Malformations Driven by PIK3CA Mutation (The ReInspire Study)
This is a 3-part Phase 2 randomized study evaluating the safety and efficacy of the mutant-selective PI3Kα inhibitor, zovegalisib (RLY-2608), in adults and children with PIK3CA Related Overgrowth Spectrum (PROS) and malformations…
- Conditions
- PIK3CA-Related Overgrowth Spectrum (PROS), Lymphatic Malformations, Vascular Malformations, PIK3CA Mutation
- Trial name
- NCT06789913
- Testing
- RLY-2608
- Where
- 40 sites in United States, Australia and 7 more
- Volunteers
- 277 people
- Sponsor
- Relay Therapeutics, Inc.
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
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…
- Trial name
- STARBORN-1 (NCT05871970)
- Testing
- TARA-002
- Where
- 11 sites in United States
- Volunteers
- 38 people
- Sponsor
- Protara Therapeutics
Lymphatic Malformation, Pediatric
Efficacy of Rapamycin in the Treatment of Cervico-facial Lymphatic Malformations
To evaluate the efficacy of Rapamycin in extended cervicofacial lymphatic malformations in pediatric patients. Rapamycin is administered oral for a 6 month period.
- Trial name
- RAPAMALYMPH (NCT03243019)
- Testing
- rapamycin, MRI, Rapamycin dosage
- Where
- 2 sites in France
- Volunteers
- 28 people
- Sponsor
- University Hospital, Lille
Slow-Flow Vascular Malformation, Fast-Flow Vascular Malformation
A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations
Recent studies have demonstrated that growth of vascular malformations can be driven by genetic variants in one of 2 signalling pathways.
- Conditions
- Slow-Flow Vascular Malformation, Fast-Flow Vascular Malformation, Vascular Malformations, Venous Malformation
- Trial name
- TARGET-VM (NCT05983159)
- Testing
- Alpelisib, Mirdametinib
- Where
- 2 sites in Australia
- Volunteers
- 50 people
- Sponsor
- Murdoch Childrens Research Institute
Lymphedema, Lymphatic Disorders
Imaging Lymphatic Function in Normal Subjects and in Persons With Lymphatic Disorders
The purpose of this study is to demonstrate the feasibility of near-infrared fluorescence imaging in subjects with acquired or hereditary lymphedema, in subjects with lipidema and other lymphovascular disorders and in normal…
- Conditions
- Lymphedema, Lymphatic Disorders, Lipedema, Vascular Malformation
- Trial name
- NCT00833599
- Testing
- NIRFLI with ICG
- Where
- 3 sites in United States
- Volunteers
- 283 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
Venous Malformation, Lymphatic Malformation
Weekly Sirolimus Therapy
In current practice, options for venous and lymphatic malformations remain limited. Recently an oral medication, sirolimus, has been found to benefit patients when taken once or twice a day for several months.
- Trial name
- NCT04861064
- Testing
- Sirolimus
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Medical University of South Carolina
Lymphatic Malformation
A Prospective Study on the Treatment of cLM Based on ICG Imaging
The goal of this prospective randomized controlled study is to explore the role of indocyanine green-fluorescence imaging in management of cystic lymphatic malformation..
- Trial name
- NCT06275022
- Testing
- Inflow occlusion with perforation of septation and sclerotherapy, Perforation of septation and sclerotherapy, Indocyanine green-guided partial resection and sclerotherapy
- Where
- China
- Volunteers
- 110 people
- Sponsor
- Nanjing Children's Hospital
Orbital Lymphatic Malformation
Systematic Approach for Children With Orbital Malformation With Sirolimus Use
The goal of this interventional study is to Set a systematic management approach for orbital lymphatic malformation and to study the safety and efficacy of sirolimus in children and adolescents with orbital lymphatic…
- Trial name
- sirolimus (NCT07378657)
- Testing
- Injection Sclerotherapy, Sirolimus (Rapamune®), both injection sclerotherapy and sirolimus
- Where
- Egypt
- Volunteers
- 30 people
- Sponsor
- Ain Shams University
Vascular Malformation, Arteriovenous Malformation
Diagnostic Imaging of Vascular Malformations Using MSOT and ULM
This clinical study evaluates the efficacy and accuracy of Multispectral Optoacoustic Tomography (MSOT) and Ultrasound Localization Microscopy (ULM) for imaging and diagnosing vascular malformations (venous, arteriovenous…
- Conditions
- Vascular Malformation, Arteriovenous Malformation, Lymphatic Malformation, Venous Malformations
- Trial name
- NCT06994260
- Testing
- Multispectral Optoacoustic Tomography, Ultrasound Localization Microscopy
- Where
- Germany
- Volunteers
- 15 people
- Sponsor
- University Hospital Erlangen
Lymphatic Malformation, Lymphatic Abnormality
Institution of an Italian Registry and Biobank for Biological Sample Collection
Lymphatic malformations (ML), are benign non-neoplastic, rare, resulting from an embryologic abnormal development of the lymphatic system.
- Conditions
- Lymphatic Malformation, Lymphatic Abnormality, Lymphangioma, Lymphatic Abnormalities
- Trial name
- IReg-LM (NCT06892964)
- Testing
- Genetic profiling of all eligible patients
- Where
- Italy
- Volunteers
- 70 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Vascular Anomalies
Radiofrequency Ablation of Vascular Anomalies
Vascular Anomalies (VA) are areas of disorganized blood vessel tissue that can appear as lumps or bumps under the skin. Sometimes they can cause you discomfort, or you may not like how they look.
- Trial name
- NCT06803667
- Testing
- Radiofrequency ablation alone
- Volunteers
- 15 people
- Sponsor
- Baylor College of Medicine
Lymphatic Malformation
Different Doses of Sirolimus for the Treatment of Cystic Lymphatic Malformations
The purpose of this study is to compare the efficacy and safety of different concentration gradients of sirolimus in the treatment of cystic lymphatic malformation.
- Trial name
- NCT06673290
- Testing
- Sirolimus (RAPAMUNE)
- Where
- China
- Volunteers
- 150 people
- Sponsor
- West China Hospital
Vascular Anomaly, Generalized Lymphatic Anomaly
Identification of Biomarkers for Patients with Vascular Anomalies
The study will use blood (serum and plasma) and tissue obtained from participants undergoing prescribed surgical resection of vascular anomalies of interest proposed in this study.
- Conditions
- Vascular Anomaly, Generalized Lymphatic Anomaly, Kaposiform Hemangioendothelioma, Kaposiform Lymphangiomatosis
- Trial name
- NCT03001180
- Where
- 2 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Lymphatic Malformation
Use of Bleomycin in the Sclerotherapy of Lymphatic Malformations for Pediatric Patients
Bleomycin has nowadays been more and more widely used in the sclerotherapy of LMs, which has been proven to be primarily dose dependent.
- Trial name
- NCT06437158
- Testing
- Bleomycin
- Where
- China
- Volunteers
- 200 people
- Sponsor
- West China Hospital