Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers (NCT02104011) | Clinical Trial Compass
TerminatedPhase 2
Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers
Stopped: target number of subject not reached
France2 participantsStarted 2015-05-22
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Tuberous sclerosis patients with one or several angiomyolipomas of a size of at least 4 cms.
Exclusion Criteria:
* Patients whom CT or MR scan shows one or several intra-lesional aneurisms requiring a preventive embolization.
* Patients with a retroperitoneal hemorragic complication requiring a preventive embolization.
* Patients whom biopsy will show an adenocarcinoma, hypertension non controlled, renal failure and severe liver.
* Diabetic subjects insufficiently controlled.
* Beta-blockers contra-indication.
* Psychosis, severe mental disorder.
* Patient already treated with beta-blockers or mTOR inhibitors.
* Pregnant or nursing women.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.