Brain MetastasesNCT05124912
REMASTer: REcurrent Brain Metastases After SRS Trial
A study testing Radiation Therapy, Steroid Therapy and Laser Interstitial Thermal Therapy in people with Brain Metastases and Radiation Necrosis, run by Monteris Medical at 9 sites in United States.
Trial summary
Randomized, post-market multi-center study investigating the efficacy of two sets of treatment algorithms in brain metastases (BM) patients at the time of first intervention for radiographic progression after stereotactic radiosurgery (SRS), with or without surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Radiation Necrosis, Recurrent Tumor
- What is being tested?
- Radiation Therapy, Steroid Therapy and Laser Interstitial Thermal Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 9 sitesUnited States
- Study dates
- 10 May 2022to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Patients with radiographically proven (by gadolinium-enhanced [Gd-] MRI) parenchymal brain metastases from histologically confirmed non-central nervous system (CNS) cancer
- Patients with a "targetable", bi-dimensionally-measurable, intracranial lesion that is considered the first radiographic recurrence after upfront treatment with SRS +/- surgery (craniotomy or LITT). Prior whole brain radiation therapy (WBRT) is permitted provided the target lesion is at first progression following SRS +/- surgery, which would have occurred after WBRT. To classify a lesion as radiographically progressive, the lesion must demonstrate a ≥ 25% increase in size, relative to the post-nadir measurement following treatment with initial SRS, based on the Response Assessment in Neuro-Oncology criteria for CNS Tumors. To be "targetable" for this study, the lesion should be expected to be coverable through a planned single LITT trajectory and thus have a maximum perpendicular diameter (perpendicular to the laser trajectory) of 3 cm. An unanticipated intra-operative decision to utilize two trajectories is acceptable and patient may remain on study
- Patient must be at least 3 months post initial SRS treatment of the target lesion
- Target lesion must be amenable to undergo surgical biopsy and LITT treatment as determined by the treating neurosurgeon
- Frozen pathology diagnosis must be attainable
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- Patient must be symptomatically stable for a minimum of 3 days prior to the procedure date on a max total daily steroid dose equivalent to 4 mg of Dexamethasone
- ≥18 years of age
- KPS ≥70
- Patient is able and willing to complete study requirements
- Patients with adequate hematologic parameters (all tests to be performed within <4 weeks of biopsy):
- ANC ≥ 1.5 X 109/L
- Platelet count ≥ 100 x 109/L
- Blood chemistry laboratory value for serum creatinine < 1.5 x ULN (test to be performed within <4 weeks of biopsy)
- 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)
- All patients of reproductive potential must agree to use an effective method of contraception during the study
- Patients must be accessible for in-person follow-up
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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, relative to the post-nadir measurement, 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 target lesion and this lesion alone may be ablated during the study procedure
- Patients with concomitant newly diagnosed intracranial metastases (concurrent with the targetable radiographically progressive lesion), as these will require prioritized and different treatment approaches. There is no limit to the number of pre-existing or stable non-target metastases
- Prior bevacizumab use within 4 weeks of study initiation
- Patients with additional concurrent malignancies, outside of the primary cancer, requiring active treatment, except non-melanoma skin cancer, or in-situ cancer of the cervix e.g. patients with multiple types of cancer on active treatment
- 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
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- Inability to tolerate or contraindication to steroid therapy (i.e., dexamethasone)
- Deemed ineligible or unable to tolerate SRS therapy by treating neurosurgeon and/or radiation oncologist
- Patients with any condition that would prohibit them from undergoing a surgical procedure, at the discretion of the treating physician team
- Patients unwilling or unable to give consent for participation
- Patients unable to comply with study requirements
- Patients with diffuse leptomeningeal disease. Small focal areas of pachymeningeal disease that are considered "stable" are acceptable with approval from study Principal Investigator
- Patients with rapidly progressing extracranial disease, with limited further treatment options
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kate Weed contact
9 sites in 1 country
United States9 sites, 8 recruiting
- Recruiting
University of Maryland
Baltimore, Maryland, 21201
Megan Camara, megan.camara@umm.edu
Mark Mishra, MD
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Agnieszka Stadnik, astadnik@bsd.uchicago.edu
Justine Lee, justinelee89@bsd.uchicago.edu
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Kayla Alejandro, ALEJANK2@ccf.org
Matthew Grabowski, MD
- Active, not recruiting
Duke University Hospital
Durham, North Carolina, 27710
- Recruiting
Kettering Health
Kettering, Ohio, 45429
Daniel Geyer, Daniel.Geyer@ketteringhealth.org
Anthony Paravati, MD
- Recruiting
UCLA
Los Angeles, California, 90095
Emma Billingslea-Yoon, EBillingslea@mednet.ucla.edu
Won Kim, MD
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Kaitlin Goetschel, kgoetschel@mcw.edu
Sarah Cornell, scornell@mcw.edu
- Recruiting
WashU
St Louis, Missouri, 63130
Mridu Kanga, kanga@wustl.edu
Albert Kim, MD, PhD
- Recruiting
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
Wendy Jenkins, wejenkin@wakehealth.edu
Adrian Laxton, MD
About this study
Randomized, post-market multi-center study investigating the efficacy of two sets of treatment algorithms in brain metastases (BM) patients at the time of first intervention for radiographic progression after stereotactic radiosurgery (SRS), with or without surgery.
- Being tested
- Radiation Therapy, Steroid Therapy, Laser Interstitial Thermal Therapy
- Keywords
- Laser Interstitial Thermal Therapy, Stereotactic Radiosurgry, LITT, SRS, Radiation Necrosis, Brain Metastases
- Medical subject headings
- Brain Neoplasms, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyProcedure or surgery
Post-op hypofractionated therapy or no radiation therapy
Steroid TherapyDrug
Best medical management with steroid therapy
Laser Interstitial Thermal TherapyProcedure or surgery
Minimally invasive technique to necrotize intracranial lesions using the NeuroBlate® System (NBS)
| Study group | Role | What they receive |
|---|---|---|
| Recurrent Tumor | Other | Receives Laser Interstitial Thermal Therapy (LITT) followed by surveillance or Receives Laser Interstitial Thermal Therapy (LITT) followed by hypofractionated radiation therapy (RT). Receives: Procedure: Radiation Therapy; Procedure: Laser Interstitial Thermal Therapy |
| Radiation Necrosis (Closed to Enrollment) | Other | Receives Laser Interstitial Thermal Therapy (LITT) and best medical management with steroids or Receives best medical management with steroids. Receives: Drug: Steroid Therapy; Procedure: Laser Interstitial Thermal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progressive Disease Cohort
Determine the effectiveness of LITT using the NeuroBlate® System with or without repeat SRS on recurrent brain metastases, as measured by freedom from local progression.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Radiation Necrosis Cohort
Determine the effectiveness of LITT using the NeuroBlate System versus standard medical management as measured by time to steroid independence without escalation of care, measured in days from LITT procedure, defined as freedom from steroids for a period of four weeks without escalation of care.
Measured: Assessed for a three month period from time of randomization to steroid freedom without escalation of care.
Secondary outcomes (2)
Progressive Disease Cohort: Overall Survival
Compare treatment approaches with respect to overall survival.
Measured: Compare treatment approaches with respect to overall survival, defined as time from study biopsy to death or study exit, up to 24 months.
Radiation Necrosis Cohort: Freedom from Local Progression (FFLP) or Neurological Death
Compare treatment approaches with respect to FFLP or neurologic death
Measured: Compare treatment approaches with respect to overall survival, defined as time from study biopsy to death or study exit, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start10 May 2022
- Primary completionDec 2026 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 261 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monteris Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Fecci, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124912
- Sponsor's protocol ID
- REMASTer
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2021
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REMASTer: REcurrent Brain Metastases After SRS Trial
- ClinicalTrials.gov ID
- NCT05124912
- Acronym / sponsor ID
- REMASTer
- Keywords
- Laser Interstitial Thermal Therapy, Stereotactic Radiosurgry, LITT, SRS, Radiation Necrosis, Brain Metastases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 261 participants (estimated)
- Lead sponsor
- Monteris MedicalIndustry (pharma, biotech, devices)
- Study start
- 10 May 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 18 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, post-market multi-center study investigating the efficacy of two sets of treatment algorithms in brain metastases (BM) patients at the time of first intervention for radiographic progression after stereotactic radiosurgery (SRS), with or without surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recurrent Tumor | Other | Procedure: Radiation Therapy, Procedure: Laser Interstitial Thermal TherapyReceives Laser Interstitial Thermal Therapy (LITT) followed by surveillance or Receives Laser Interstitial Thermal Therapy (LITT) followed by hypofractionated radiation therapy (RT). |
| Radiation Necrosis (Closed to Enrollment) | Other | Drug: Steroid Therapy, Procedure: Laser Interstitial Thermal TherapyReceives Laser Interstitial Thermal Therapy (LITT) and best medical management with steroids or Receives best medical management with steroids. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Patients with radiographically proven (by gadolinium-enhanced [Gd-] MRI) parenchymal brain metastases from histologically confirmed non-central nervous system (CNS) cancer
- Patients with a "targetable", bi-dimensionally-measurable, intracranial lesion that is considered the first radiographic recurrence after upfront treatment with SRS +/- surgery (craniotomy or LITT). Prior whole brain radiation therapy (WBRT) is permitted provided the target lesion is at first progression following SRS +/- surgery, which would have occurred after WBRT. To classify a lesion as radiographically progressive, the lesion must demonstrate a ≥ 25% increase in size, relative to the post-nadir measurement following treatment with initial SRS, based on the Response Assessment in Neuro-Oncology criteria for CNS Tumors. To be "targetable" for this study, the lesion should be expected to be coverable through a planned single LITT trajectory and thus have a maximum perpendicular diameter (perpendicular to the laser trajectory) of 3 cm. An unanticipated intra-operative decision to utilize two trajectories is acceptable and patient may remain on study
- Patient must be at least 3 months post initial SRS treatment of the target lesion
- Target lesion must be amenable to undergo surgical biopsy and LITT treatment as determined by the treating neurosurgeon
Key exclusion criteria (13 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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, relative to the post-nadir measurement, 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 target lesion and this lesion alone may be ablated during the study procedure
- Patients with concomitant newly diagnosed intracranial metastases (concurrent with the targetable radiographically progressive lesion), as these will require prioritized and different treatment approaches. There is no limit to the number of pre-existing or stable non-target metastases
- Prior bevacizumab use within 4 weeks of study initiation
- Patients with additional concurrent malignancies, outside of the primary cancer, requiring active treatment, except non-melanoma skin cancer, or in-situ cancer of the cervix e.g. patients with multiple types of cancer on active treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation TherapyPost-op hypofractionated therapy or no radiation therapy | Procedure or surgery | Recurrent Tumor |
| Steroid TherapyBest medical management with steroid therapy | Drug | Radiation Necrosis (Closed to Enrollment) |
| Laser Interstitial Thermal TherapyMinimally invasive technique to necrotize intracranial lesions using the NeuroBlate® System (NBS) | Procedure or surgery | Radiation Necrosis (Closed to Enrollment), Recurrent Tumor |
Primary outcome
Progressive Disease Cohort
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Determine the effectiveness of LITT using the NeuroBlate® System with or without repeat SRS on recurrent brain metastases, as measured by freedom from local progression.
Radiation Necrosis Cohort
Time frame: Assessed for a three month period from time of randomization to steroid freedom without escalation of care.
Determine the effectiveness of LITT using the NeuroBlate System versus standard medical management as measured by time to steroid independence without escalation of care, measured in days from LITT procedure, defined as freedom from steroids for a period of four weeks without escalation of care.
2 secondary outcomes
Progressive Disease Cohort: Overall Survival
Time frame: Compare treatment approaches with respect to overall survival, defined as time from study biopsy to death or study exit, up to 24 months.
Radiation Necrosis Cohort: Freedom from Local Progression (FFLP) or Neurological Death
Time frame: Compare treatment approaches with respect to overall survival, defined as time from study biopsy to death or study exit, up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kate Weed contact
Peter Fecci, MD principal investigator
University of Colorado, Denver
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation Therapy, Steroid Therapy and Laser Interstitial Thermal Therapy in people with Brain Metastases and Radiation Necrosis, run by Monteris Medical at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christa Seligman (952-463-7747, cseligman@monteris.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progressive Disease Cohort (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.