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Laser zaps recurrent brain tumors: new trial tests minimally invasive option

NCT ID NCT05124912

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is for people whose brain metastases have come back or caused radiation damage after initial treatment. It compares a laser-based procedure (LITT) plus standard care against standard care alone (steroids or repeat radiation). The goal is to see if LITT can better control tumor growth and help patients stop using steroids sooner. About 261 participants will be enrolled across multiple centers.

What this could mean

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

Active substance
Laser Interstitial Thermal Therapy (LITT) using the NeuroBlate System
What this could lead to
If successful, this could offer a more effective, less invasive option to control recurrent brain tumors or radiation damage after initial treatment.
What could go wrong
This is a mid-stage trial with 261 participants, so results are not yet proven. Risks include surgical complications from LITT and the possibility that the treatment may not improve survival or reduce steroid use.

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

About 261 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Patients with radiographically proven (by gadolinium-enhanced \[Gd-\] MRI) parenchymal brain metastases from histologically confirmed non-central nervous system (CNS) cancer. 2. Patients with a "targetable", bidimensionally-measurable, intracranial lesion that is radiographically recurrent after previous treatment with SRS +/- surgery (craniotomy or LITT). To classify a lesion as radiographically progressive, the lesion must demonstrate a ≥ 25% increase in size following treatment based on the Neuro-Oncology Criteria of Tumor Response for CNS Tumors. To be "targetable" for this study, the lesion should be coverable through a planned single LITT trajectory and thus have a maximum perpendicular diameter (perpendicular to the laser trajectory) of 3 cm. An intra-operative decision to utilize two trajectories is acceptable and patient may remain on study. 3. Patient must be at least 3 months post initial SRS treatment of the target lesion 4. Target lesion must be amenable to undergo surgical biopsy and LITT treatment as determined by the treating neurosurgeon. 5. Frozen pathology diagnosis must be attainable. 6. Patient must be symptomatically stable for a minimum of 3 days prior to the procedure date on a on a max total daily steroid dose equivalent to 4mg of Dexamethasone. 7. ≥18 years of age 8. KPS ≥70 9. Patient is able and willing to complete study requirements 10. Patients with adequate hematologic parameters (all tests to be performed within \<4 weeks of biopsy): 1. ANC ≥ 1.5 X 109/L 2. Platelet count ≥ 100 x 109/L 11. Blood chemistry laboratory value for serum creatinine \< 1.5 x ULN (test to be performed within \<4 weeks of biopsy) 12. Female patients must have a negative serum pregnancy test at screening. (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal) 13. All patients of reproductive potential must agree to use an effective method of contraception during the study 14. Patients must be accessible for follow-up Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Patients with greater than 3 progressing lesions at time of enrollment. To classify as a radiographically progressive, lesion must demonstrate a ≥ 25% increase in size following treatment based on the RANO criteria. Of note, there is no exclusion for total number of metastases. However, only one lesion can be selected to be the targeted lesion and this lesion alone may be ablated during the study procedure. 2. Patients with concomitant newly diagnosed intracranial metastases (concurrent with the targetable radiographically progressive lesion), as these will require prioritized and different treatment approaches. 3. Prior bevacizumab use within 4 weeks of study initiation 4. Patients with additional concurrent malignancies requiring active treatment, except non-melanoma skin cancer, or in-situ cancer of the cervix 5. Patients with a serious active infection or other serious underlying medical conditions that would impair the ability of the patient to complete the protocol related QOL questionnaires and cognition assessments 6. Inability to tolerate or contraindication to steroid therapy (i.e., dexamethasone) 7. Deemed ineligible or unable to tolerate SRS therapy by treating neurosurgeon and/or radiation oncologist 8. Patients with any condition that would prohibit them from undergoing a surgical procedure, at the discretion of the treating physician team 9. Patients unwilling or unable to give consent for participation 10. Patients unable to comply with study requirements 11. Patients with diffuse leptomeningeal disease 12. Patients with rapidly progressing extracranial disease

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Duke University Hospital

    ACTIVE_NOT_RECRUITING

    Durham, North Carolina, 27710, United States

  • Kettering Health

    RECRUITING

    Kettering, Ohio, 45429, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • UCLA

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Maryland

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • Wake Forest Baptist Medical Center

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • WashU

    RECRUITING

    St Louis, Missouri, 63130, United States

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