Neoplasms

Symptoms and General Pathology

All Conditions

Nervous System Diseases

Neoplasm Metastasis

Recurrence

Necrosis

Neoplasms, Second Primary

Brain Neoplasms

Disease Attributes

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

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

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

Post-op hypofractionated therapy or no radiation therapy

Radiation Therapy

Best medical management with steroid therapy

Steroid Therapy

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

Laser Interstitial Thermal Therapy

Christa Seligman

Beth Perry

Peter Fecci, MD

Wendy Jenkins

Adrian Laxton, MD

Allison Dymacek

Mark Hoeprich, MD

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.

REMASTer: REcurrent Brain Metastases After SRS Trial

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.

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.

Compare treatment approaches with respect to overall survival.

Compare treatment approaches with respect to FFLP or neurologic death

Monteris Medical

Amino Acids

All Drugs and Chemicals

Methionine

Stage 4 cancer patient population with melanoma with brain metastases previously treated with SRS

Stage 4 cancer patient population with non-small cell lung cancer with brain metastases previously treated with SRS

\[11C\]Methionine \[11\]. This natural amino acid, and its various fluorinated derivatives, has been widely used in brain tumor studies due to a) high tumor-to-normal brain contrast, and b) its sensitivity to biological functions including amino acid transport and utilization. \[11C\]PBR28 \[12\]. This ligand is one of a series of second-generation tracers that bind to TSPO (translocator protein), a protein that is upregulated in activated microglia.

Standard of Care FDG-PET Imaging

Veronica Chiang, MD

The goal of this protocol is to evaluate the potential of PET imaging of amino acid transport and microglial activation to improve the differentiation of tumor recurrence and radiation necrosis in patients with brain metastases after treatment with stereotactic radiosurgery (SRS) who have re-growing lesions. These state-of-the-art imaging tools will be used in combination with standard magnetic resonance imaging (MRI), MR spectroscopy (MRS) and FDG-PET (fluorodeoxyglucose).

The investigators hypothesize that by using two different PET tracers, one sensitive to tumor metabolic activity, and one sensitive to inflammatory processes, investigators can separately identify metabolically active tumor from radiation necrosis related inflammation. This can be accomplished with quantitative assessments of tracer uptake using kinetic modeling techniques, as well as by high-resolution imaging to assess the distribution of tracer uptake in the tumor region. All participants in the study will have the receive the same diagnostic tests.

Methionine and PBR28-PET (Peripheral Benzodiazepine Receptors) in Brain Metastases Following Radiosurgery

Studies of Methionine-PET and PBR28-PET in Brain Metastases to Differentiate Tumor Recurrence and Radiation Necrosis Following Stereotactic Radiosurgery

Yale University

Behaviors and Mental Disorders

Disease Progression

Quality of Life

Patients with radiographic evidence of lesion regrowth following prior treatment with stereotactic radiosurgery (regardless of the process being suspected recurrent or progressive brain metastasis versus radiation necrosis) and who already scheduled for NeuroBlate procedure.

The need for new technologies and devices in the field of neurosurgery is well established. In April 2013, FDA cleared NeuroBlate™ System, minimally invasive robotic laser thermotherapy tool. It employs a pulsed surgical laser to deliver targeted energy to abnormal brain tissue caused by tumors and lesions. This post-marketing, multi-center study will include patients with metastatic tumors who failed stereotactic radiosurgery and are already scheduled for NeuroBlate procedure. The study will collect clinical outcome, Quality of Life (QoL) and, where feasible, healthcare utilization data for publication.

Laser Ablation After Stereotactic Radiosurgery

To describe local (CNS) progression-free survival rate in patients with failed radiosurgery for brain metastases treated with the NeuroBlate System. Sites were requested to submit imaging to a centralized core laboratory for analysis. A total of 27 patients had images submitted--27/42 (64%) of patients submitted follow-up images at 12-weeks and 16/42 (38%) patients submitted follow-up imaging at 26 weeks. Due to the low submission of follow-up images at 26-weeks, 12-weeks and last follow-up are reported.

FACT-Br questionnaire sub-scores (Physical well-being, social/family well-being, emotional well-being, functional well-being, brain cancer subscale) are summed together, leading to a FACT-Br total score on a scale from 0-200; larger scores indicate better overall quality of life. This outcome measured the FACT-Br score change from Baseline at both 12 and 26 weeks post NeuroBlate procedure (values at 12 and 26 weeks, respectively, minus value at baseline). Version 4 of the Fact-BR scoring guidelines were used.

To describe/estimate the overall survival after the NeuroBlate Procedure.

To continue to monitor factors impacting the safe and efficacious use of NeuroBlate

Events adjudicated as surgery- or LITT- associated are described in the adverse events section.

Main Cohort

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Biopsy-confirmed radiation necrosis or metastatic brain tumor

Limitations are discussed by the physicians in the full publication of the LAASR study data (open access): http://thejns.org/doi/pdf/10.3171/2017.11.JNS171273

Nissa Mollema (Clinical Operations Manager)

12-weeks

Last Follow-up

NeuroBlate Procedure

Sites were requested to submit imaging to a centralized core laboratory for analysis. A total of 27 patients had images submitted--27/42 (64%) of patients submitted follow-up images at 12-weeks and 16/42 (38%) patients submitted follow-up imaging at 26 weeks.

Percentage of Patients With Progression-Free Survival (PFS)

Change in 12-week FACT-Br from Baseline

Change in 26-week FACT-Br from Baseline

Due to study attrition, the full cohort was unavailable for analysis.

Quality of Life (Change in The Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score.

12-week Kaplan-Meier survival

26-week Kaplan-Meier survival

Overall Survival

Percentage of Patients With Laser Ablation Related Adverse Events

Patients with radiographic evidence of lesion regrowth following prior treatment with stereotactic radiosurgery (regardless of the process being suspected recurrent or progressive brain metastasis versus radiation necrosis) and who underwent the NeuroBlate procedure

Overall Study

Patients with brain metastases who received stereotactic radiosurgery

Pre-and post-contrast enhanced T1-weighted image, T2-weighted image, fluid-attenuated inversion recovery image

Magnetic resonance imaging (MRI)

Diffusion-weighted MRI

Arterial spin labeling (ASL)

Cerebral blood volume and vessel architectural imaging parameters

Dynamic susceptibility contrast-MRI (DSC-MRI)

Ho Sung Kim, MD, PhD

Ji Eun Park, MD, PhD

This trial uses multi-parametric magnetic resonance imaging (MRI) to develop and validate imaging risk score to predict radiation necrosis in participants with brain metastasis treated with radiation therapy. Diagnostic procedures, such as multi-parametric magnetic resonance imaging (MRI), may improve the ability to diagnose radiation necrosis early and help establish treatment strategies.

PRIMARY OBJECTIVE:

I. To develop an imaging risk score for recurrence after stereotactic radiosurgery (SRS) in brain metastasis using multiparametric MRI.

II. To validate the imaging risk score in retrospective external validation and prospective internal validation test set.

SECONDARY OBJECTIVE:

I. To predict radiation necrosis using imaging risk score.

OUTLINE:

Participants undergo multi-parametric MRI including 3D pre- and contrast-enhanced T1 weighted image, T2 weighted image, diffusion-weighted image, dynamic susceptibility contrast MRI, and arterial spin labeling image before receiving SRS, and every 3 months after SRS.

Imaging Features for the Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis

Imaging Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis (IRRAS-BM)

The time from the date of SRS for brain metastasis until the date of progression.

The response is determined by response assessment in neuro-oncology brain metastases (RANO-BM) criteria. Clinical and radiologic assessments per lesion and person are carried out at every MRI follow-up using the MRI before SRS as the baseline.

The rate of occurrence of radiation necrosis per lesion is determined through a combination of imaging findings and clinical evaluation by a multidisciplinary team.

To calculate the imaging risk score, three parameters are added together, namely the "solid component score," the "less enhancing component score," and the "blood flow score," using contrast-enhanced T1-weighted image(T1WI), T2-weighted image (T2WI), diffusion-weighted imaging (DWI), and ASL.

The solid component risk score is assigned 0, 1, or 2 points, depending on whether the hypointense lesion on T2WI matches the enhancement in CE-T1WI.

The less-enhancing component risk score evaluates the degree of enhancement of the lesion to the dura. It assigns 0, 1, or 2 points depending on whether it is brighter, similar, or less enhanced.

The blood flow risk score assigns 0, 1, or 2 points based on the degree of blood flow of the lesion in ASL.

Automated process of tumor habitat analysis will include followings.

A. Methods: preprocessing includes registration, deep learning segmentation, and normalization of contrast-enhanced T1-weighted (CE-T1) and T2-weighted images. K-means clustering is applied to CE-T1-weighted and T2-weighted images to construct structural MRI habitats and to apparent diffusion coefficient (ADC) and cerebral blood volume (CBV) images to construct physiologic habitats.

B. Structural MRI habitats: enhancing tissue habitat, solid low-enhancing habitat, and nonviable tissue habitat

C. Physiologic MRI habitats: hypervascular cellular habitat, hypovascular cellular habitat, and nonviable tissue habitat..

D. Quantitative measurement of each habitat will be performed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
REMASTer: REcurrent Brain Metastases After SRS Trial	NCT05124912	Brain Metastase... Radiation Necro... Recurrent Tumor Recurrent Metas...	Radiation Thera... Steroid Therapy Laser Interstit...	18 Years -	Monteris Medical
Methionine and PBR28-PET (Peripheral Benzodiazepine Receptors) in Brain Metastases Following Radiosurgery	NCT02433171	Brain Metastasi...	Standard of Car...	18 Years - 80 Years	Yale University
Laser Ablation After Stereotactic Radiosurgery	NCT01651078	Metastatic Brai... Progression Radiation Necro... Quality of Life		18 Years -	Monteris Medical
Imaging Features for the Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis	NCT05868928	Brain Metastase... Radiosurgery	Magnetic resona... Diffusion-weigh... Arterial spin l... Dynamic suscept...	18 Years -	Asan Medical Center
Imaging Features for the Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis	NCT05868928	Brain Metastase... Radiosurgery	Magnetic resona... Diffusion-weigh... Arterial spin l... Dynamic suscept...	18 Years -	Asan Medical Center
Methionine and PBR28-PET (Peripheral Benzodiazepine Receptors) in Brain Metastases Following Radiosurgery	NCT02433171	Brain Metastasi...	Standard of Car...	18 Years - 80 Years	Yale University

Spots Global Cancer Trial Database for radiation necrosis