What side effects are associated with this type of intervention?

Common treatments for brain aneurysms include endovascular procedures such as coiling and stent-assisted coiling. Known side effects of these treatments can include thromboembolic events, intraprocedural hemorrhage, and complications related to the use of antiplatelet agents like tirofiban, which may cause bleeding or thromboembolic complications. While the specific side effects of Sirolimus (an mTOR inhibitor) in the context of brain aneurysms are not detailed, mTOR inhibitors generally can cause side effects such as immunosuppression, increased risk of infection, and potential impacts on wound healing.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically for brain aneurysms that involve mTOR inhibitors like Sirolimus. Sirolimus, also known as Rapamycin, is primarily used for its immunosuppressive and antiproliferative properties in conditions such as preventing organ transplant rejection and treating certain cancers. While studies are exploring its potential in treating cerebral aneurysms by targeting molecular alterations, these applications are still under investigation and not yet approved for clinical use in brain aneurysms.

What other types of research exist?

Currently, there are no specific novel alternatives to Sirolimus (mTOR inhibition) for brain aneurysm treatment mentioned in the provided context. Patients should consult their healthcare providers to discuss the latest research and potential new treatments available in 2024.

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mTOR inhibitor

Sirolimus for Brain Aneurysm

Phase 2

Recruiting

Led By Robert M Starke, M.D.

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing one of the following procedures at Jackson Memorial Hospital: Clipping of an unruptured cerebral artery aneurysm, Endovascular treatment of unruptured cerebral aneurysms (including those receiving coiling)

≥ 18 years of age

Must not have

History of skin cancer

Patient with renal or liver failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 18

Awards & highlights

Summary

This trial is investigating the use of Sirolimus, a drug that helps control immune responses and cell growth, in patients with cerebral aneurysms. The goal is to see if Sirolimus can affect the molecular changes in the blood vessels of the brain. By altering how cells grow and repair, Sirolimus may help manage these dangerous bulges in brain blood vessels. Sirolimus has been used in various clinical settings, including kidney and liver transplantation, to reduce the risk of cancer and improve survival rates.

Who is the study for?

This trial is for adults over 18 who are getting surgery or endovascular treatment for unruptured brain aneurysms at Jackson Memorial Hospital and can consent to participate. It's not for those with HIV, certain types of aneurysms, pregnant or breastfeeding women, severe psychiatric conditions, skin cancer history, sirolimus allergy, serious illnesses affecting study results, lung disease called interstitial pneumonitis, or kidney/liver failure.

What is being tested?

The trial studies the effect of Sirolimus on brain aneurysm molecular changes. Participants will receive either microsurgical clipping or endovascular treatment along with Sirolimus to see how it influences the condition at a molecular level.

What are the potential side effects?

Sirolimus may cause side effects like increased risk of infection due to immune system suppression, potential lung problems (interstitial pneumonitis), allergic reactions in those sensitive to it and could worsen existing liver or kidney issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for a procedure at Jackson Memorial Hospital to treat an unruptured brain aneurysm.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had skin cancer in the past.

Select...

I have kidney or liver failure.

Select...

I have a specific type of brain aneurysm.

Select...

I have a history of lymphoma.

Select...

I have interstitial pneumonitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 18

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 18 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body Weight Changes

Change in gene expression from control arteries.

Change in gene expression.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Microsurgical Clipping Treated with SirolimusExperimental Treatment2 Interventions

Participants undergoing standard of care microsurgical clipping of unruptured cerebral aneurysm will be treated with 2 mg Sirolimus daily for 14-18 consecutive days prior to surgery.

Group II: Endovascular Treatment Treated with SirolimusExperimental Treatment2 Interventions

Participants undergoing standard of care endovascular treatment of unruptured cerebral aneurysm procedure will be treated with 2 mg Sirolimus daily for 14-18 consecutive days prior to procedure.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sirolimus

2013

Completed Phase 4

~2750

Endovascular treatment

2017

Completed Phase 1

~500

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for brain aneurysms include surgical clipping, endovascular coiling, and the use of medications like Sirolimus that inhibit the mTOR pathway. Surgical clipping involves placing a clip at the base of the aneurysm to prevent blood flow into it, thereby reducing the risk of rupture. Endovascular coiling involves inserting coils into the aneurysm to promote blood clotting and stabilize the aneurysm. Sirolimus, an mTOR inhibitor, works by targeting molecular pathways that contribute to aneurysm growth and stability. Understanding these mechanisms is crucial for patients as it helps in selecting the most appropriate treatment based on the aneurysm's characteristics and the patient's overall health, potentially improving outcomes and reducing the risk of complications.

Treatment of intracranial aneurysms associated with other entities.[Efficacy of medical treatment (isoproterenol + aminophylline) of aneurysm rupture spasm].