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Can splitting radiation save more hearing in acoustic neuroma patients?

NCT ID NCT02055859

Disease control Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests two ways of delivering Cyberknife radiation to people with acoustic neuromas, benign tumors on the hearing nerve. One group receives a single radiation session, while the other receives three sessions. The goal is to see which approach better preserves useful hearing while still controlling the tumor. Researchers will track hearing function and tumor size on MRI scans over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cyberknife radiosurgery, a precise radiation treatment given either as a single session or as three sessions
What this could lead to
If splitting the radiation into three sessions works better, it could offer a way to treat acoustic neuromas while preserving more hearing for longer.
What could go wrong
This is a randomized trial, but hearing preservation may still vary. Radiation can damage hearing over time, and the benefit of multiple sessions is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

108 people

The number who actually took part.

Started

Mar 2011

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Sporadic acoustic neuroma max diameter 3 cm * Age: ≥ 18 years old * KPS ≥ 70 * Serviceable hearing (class A and B from the American Academy of Otorhinolaryngology-Head and Neck Surgery classification) * Written consent Exclusion Criteria: * Pregnancy * Allergy to contrast medium * Neurofibromatosis type 2 (NF2) * anacousia

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Conditions

The condition(s) this trial relates to.

acoustic neuroma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sporadic acoustic neuromas Useful hearing

Contacts and locations

Locations

  • Istittuto Nazionale Neurologico Carlo Besta

    Milan, Mi, 20133, Italy