Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers (STBETA)
Treatment of angiomyolipomas is based on invasive techniques such as surgery or embolization. Development of anti-angiogenic therapies is a major and growing field of research in hypervascularized tumors. Angiomyolipomas have been shown to regress after prolonged treatment with mTOR inhibitors (Sirolimus), but with a large proportion of secondary effects. We showed recently that beta-blockers were able to induce regression of infantile hemagiomas. Consequently, we looked for and found, histologically, in a few cases of angiomyolipomas the presence of beta2 receptors.
The aim of the study is to estimate if beta-blockers could induce regression or stabilization of renal angiomyolipomas in tuberous sclerosis in a pilot study.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers: Pilot Trial|
- Evolution of angiomyolipomas volume [ Time Frame: 6 months and 1 year after inclusion ] [ Designated as safety issue: No ]Stabilization or even regression of angiomyolipomas volume after 6 months and 1 year of treatment with a quantification of the vascular component.
- Renal function evolution [ Time Frame: 6 months and 1 year after inclusion ] [ Designated as safety issue: No ]Improvement of renal function after 6 months and 1 year of treatment
- Effect on the potential haemorraghic transformation [ Time Frame: 6 months and 1 year after inclusion ] [ Designated as safety issue: No ]Haemorraghic transformation of angiomyolipomas is diagnosed by Scanner or MRI.
- Improvement of the quality of life [ Time Frame: 6 months and 1 year after inclusion. ] [ Designated as safety issue: No ]Th evolution of the quality of life is assessed by an EVA scale and by QOL scale.
- Effect on face angiofibromas [ Time Frame: 6 months and 1 year after inclusion ] [ Designated as safety issue: No ]Evolution of the face angiofibromas by a dermatologic assessment.
|Study Start Date:||May 2015|
|Estimated Study Completion Date:||April 2017|
|Estimated Primary Completion Date:||April 2017 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02104011
|Contact: Claire RIGOTHIER, Drfirstname.lastname@example.org|
|Contact: Christian COMBE, Premail@example.com|
|Principal Investigator:||Claire RIGOTHIER, Dr||UH Bordeaux|