Recruiting

Recurrence After SRS

Sponsor:

Monteris Medical

Code:

NCT05124912

Conditions

Brain Metastases

Radiation Necrosis

Recurrent Tumor

Recurrent Metastases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiation Therapy

Steroid Therapy

Laser Interstitial Thermal Therapy

Study Details

Brief 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.

Conditions

Brain Metastases

Radiation Necrosis

Recurrent Tumor

Recurrent Metastases

Study ID

NCT05124912

Start date

May 10, 2022

Status verified date

Jun, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

261 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Recurrent Tumor

Receives Laser Interstitial Thermal Therapy (LITT) followed by surveillance or Receives Laser Interstitial Thermal Therapy (LITT) followed by hypofractionated radiation therapy (RT).

other: Radiation Necrosis

Receives Laser Interstitial Thermal Therapy (LITT) and best medical management with steroids or Receives best medical management with steroids.

Interventions

Radiation Therapy

Post-op hypofractionated therapy or no radiation therapy

Steroid Therapy

Best medical management with steroid therapy

Laser Interstitial Thermal Therapy

Minimally invasive technique to necrotize intracranial lesions using the NeuroBlate® System (NBS)

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 ]
  • Radiation Necrosis Cohort [ Time Frame: Assessed for a three month period from time of randomization to steroid freedom without escalation of care. ]

Central Contacts and Locations

Central contacts

Locations

UCLA

Recruiting

Los Angeles, California, United States, 90095

Contacts

Emma Billingslea-Yoon

EBillingslea@mednet.ucla.edu

Principal Investigator:

Won Kim, MD

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Principal Investigator:

Peter Warnke, MD

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Principal Investigator:

Mark Mishra, MD

WashU

Recruiting

St Louis, Missouri, United States, 63130

Contacts

Mridu Kanga

kanga@wustl.edu

Principal Investigator:

Albert Kim, MD, PhD

Wake Forest Baptist Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Principal Investigator:

Adrian Laxton, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Kayla Alejandro

ALEJANK2@ccf.org

Principal Investigator:

Matthew Grabowski, MD

Kettering Health

Recruiting

Kettering, Ohio, United States, 45429

Contacts

Principal Investigator:

Anthony Paravati, MD

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Kaitlin Goetschel

kgoetschel@mcw.edu

Sarah Cornell

scornell@mcw.edu

Principal Investigator:

Max Krucoff, MD

More Information

Sponsor

Monteris Medical

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

  • Laser Interstitial Thermal Therapy
  • Stereotactic Radiosurgry
  • LITT
  • SRS
  • Radiation Necrosis
  • Brain Metastases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Monteris Medical on 2026-06-18.