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Can targeted radiation save sight while shrinking eye tumors?

NCT ID NCT02594709

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether multisession radiosurgery, a precise form of radiation delivered in several doses, can control optic nerve sheath meningiomas, benign tumors that grow around the nerve connecting the eye to the brain. Researchers will enroll about 50 adults with a single suspected tumor and will treat them with five sessions of radiation totaling 25 Gy. The main goals are to see whether the treatment stops tumor growth and preserves or improves visual function, while tracking any side effects.

What this could mean

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

Active substance
Multisession radiosurgery (Cyberknife radiation therapy)
What this could lead to
If it works, this could offer a non-surgical way to control these benign tumors while preserving vision, reducing the need for invasive procedures.
What could go wrong
This is an observational study with a small number of participants, so results may not apply broadly. Radiation near the optic nerve carries a risk of vision damage, and the tumor may still grow.

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

56 people

The number who actually took part.

Started

Jan 2011

Finished

Jun 2023

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: * Age: ≥ 18 years old * Patients with suspected optic nerve sheath meningioma (single lesion) Pain and/or neurologic deficit * KPS ≥ 70 * Written consent Exclusion Criteria: * Pregnancy * Bilateral meningioma or chiasma involved * Allergy to contrast medium

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Conditions

The condition(s) this trial relates to.

optic nerve neoplasm optic nerve sheath meningioma

As listed by the trial registrant

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

Optic nerve sheath tumors, benign

Contacts and locations

Locations

  • Instittuto Nazionale Neurologico Carlo Besta

    Milan, Mi, 20133, Italy