REMASTer: REcurrent Brain Metastases After SRS Trial

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05124912
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Monteris Medical
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Metastases, Radiation Necrosis, Recurrent Tumor, Recurrent Metastases

Arms & Interventions

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

Procedure: - Radiation Therapy

Post-op hypofractionated therapy or no radiation therapy

Drug: - Steroid Therapy

Best medical management with steroid therapy

Procedure: - Laser Interstitial Thermal Therapy

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Duke University Hospital, Durham, North Carolina

Status

Recruiting

Address

Duke University Hospital

Durham, North Carolina, 27710

Site Contact

Beth Perry

[email protected]

952-463-7747

Wake Forest Baptist Medical Center, Winston-Salem, North Carolina

Status