Neoplasms

Nervous System Diseases

All Conditions

Symptoms and General Pathology

Brain Neoplasms

Neoplasm Metastasis

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

This is a feasibility study to evaluate the accuracy of an alternative, non-invasive immobilization system in combination with image guided patient setup for SRS treatments. The aim is to determine whether or not the non-invasive system can provide comparable accuracy as the conventional invasive head ring system. If successful, patient discomfort can be significantly reduced for such treatments.

Each patient in the protocol will receive their regularly scheduled SRS treatment plus an additional mock treatment using the non-invasive immobilization system.

Fabrication of thermoplastic face (The Orfit thermoplastic face mask system is routinely used for the treatment of brain and head)

Yoshiya Yamada, MD

Stereotactic radiosurgery (SRS) is a way to accurately treat brain tumors. SRS involves the use of a special head frame to keep the head from moving during treatment. The head frame makes very accurate treatment possible. The frame must be attached to the skull with special pins. It feels very tight and can hurt. A special immobilization device can be used to keep the head from moving.

This device does not need any pins and does not hurt. We would like to see if the new way of holding the head still can be used for SRS. This is the purpose of the study. New X-Ray machines can be used to find if the head has moved in the mask. We hope that we can use these new tools to treat brain tumors just as accurately without using a head frame. It will make treatment more comfortable for the patient. This is why we are asking patients to join the study.

A Feasibility Study of Image Guided Noninvasive Single Fraction Stereotactic Radiosurgery for the Treatment of Brain Metastases

Memorial Sloan Kettering Cancer Center

Rare Diseases

Glioma

ExAblate Transcranial System

A Study to Evaluate the Safety and Feasibility of Transcranial MRI-Guided Focused Ultrasound Surgery in the Treatment of Brain Tumors

Although the initial treatment of malignant gliomas is well established, the best treatment for progressive disease remains undefined. Patients with newly diagnosed gliomas are typically treated with surgery followed by conformal radiation and concomitant chemotherapy. Even though these tumors are not curable, prolonged survival can be achieved in selected patients. Despite improved multimodal therapies, almost all of the patients experience recurrence at the site of the primary tumor where they have already received maximal surgical resection and radiation therapy. Typically, these patients have a life expectancy of approximately 6 months, with less than a third of patients alive at one year. Salvage therapy for these patients usually take the form of various systemic chemotherapeutic agents because localized therapies such as reirradiation may not be possible in the previously irradiated site. As progressive disease has very poor response rates to current systemic therapies, efforts to define the role of novel local therapies, such as MR guided focused ultrasound (MRgFUS), is necessary.

There are very few local therapy options for progressive gliomas. Traditionally, reirradiation and surgery are considered last resort treatments for symptomatic recurrence. In the initial treatment of gliomas, the tumor and surrounding brain receive near tolerance doses and usually preclude a second course of radiation therapy. If clinically advisable and feasible, a second operation may be undertaken but is usually reserved for younger patients with a good neurological status who are developing neurological symptoms related to the mass effect of the tumor. The use of MR guided focused ultrasound represents a new, noninvasive therapeutic option that overcomes some of the limitations of secondary surgery or reirradiation and provides the patient with an option for local ablative therapy. The lesioning of the tumor is done accurately under MRI guidance with real-time monitoring of the ablative ultrasonic hyperthermia. As the cytotoxic affects are due to hyperthermia, there is no cumulative radiation affect which limits the use of radiotherapy in recurrent disease. The potential benefits for the patient include local control of the disease/tumor, and prolonging the time to subsequent salvage therapies.

A similar situation exists for brain metastases. Historically, the development of brain metastases was considered a terminal event, however, with better local therapies as well a systemic therapies, patients are living longer. Initial management of patients with brain metastases usually involves surgery, whole brain radiation, radiosurgery or a combination of these modalities depending on the clinical situation. The goal of treating brain metastases is to prevent the patient from succumbing to CNS disease. As improved systemic therapy has lengthened the survival of patients with metastatic tumors, more patients are surviving and developing recurrent or progressive metastatic CNS disease. Progressive disease usually requires more local therapies as chemotherapeutic agents do not adequately cross the blood brain barrier to have a large impact on CNS metastases. MRIgFUS could play and important role in ablating brain metastases in patients who have already been maximally radiated and are otherwise without options.

ExAblate (Magnetic Resonance-guided Focused Ultrasound Surgery) Treatment of Brain Tumors

To evaluate the incidence and severity of Adverse Events (AEs) associated with the ExAblate Transcrainal device during ExAblate treatment

InSightec

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Neoplastic Processes

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

111In-DAC

Diagnostic

The purpose of this study is to investigate the safety and imaging ability of 111In-DAC when used with planar and SPECT imaging for the detection of lung cancer and brain cancer consistent with metastatic lung cancer.

Study of 111In-DAC as an Medical Imaging Agent for Lung Cancer and Brain Cancer Consistent With Metastatic Lung Cancer

Copharos

Antineoplastic Agents

All Drugs and Chemicals

Carmustine

Antineoplastic Agents, Alkylating

Alkylating Agents

Resect the tumor as completely as possible. After repeated irrigation of the decompressed area demonstrates no bleeding, and care is taken not to have any foreign material enter the ventricle, up to 8 GLIADEL wafers should be placed to cover the entire surface area of the resection cavity (if possible). Slight overlapping of wafer edges is permitted. The number of wafers will be determined by the size of the tumor resection cavity. Each GLIADEL wafer contains 7.7 mg of carmustine, resulting in a dose of 61.6 mg when 8 wafers are implanted. The GLIADEL wafer is a round white to yellow disk with flat surfaces.

GLIADEL

The purpose of this study is to determine the effect of the surgical intervention and insertion of GLIADEL wafers on the neurocognitive functioning in patients with metastatic brain cancer.

Exploratory Study, Evaluating the Treatment Effect of Surgery Plus GLIADEL® Wafer in Patients With Metastatic Brain Cancer

A Phase 2, Multicenter, Exploratory Study, Evaluating the Treatment Effect of Surgery Plus GLIADEL® Wafer in Patients With Metastatic Brain Cancer

NF was assessed as the performance of 3 neurocognitive domains:memory(MD),executive function(EFD), fine motor coordination(FMCD). For each domain, z-scores were derived from participant's scores in individual neurocognitive tests using an age-adjusted and education-adjusted normative distribution of scores from an unimpaired population.Individual z-scores from related tests were averaged to determine overall z-score.If a z-score average decreased from baseline by greater than or equal to(\>=)3 standard deviations(SD)in tests' normative age-adjusted distribution on 2 consecutive visits or decreased by \>=3 SD on last follow-up visit, participant were considered to have significant deterioration in their NF at time of the first decrease in z-score.Deterioration in NF:demonstrated deterioration for at least two of the three neurocognitive domains based on these changes from screening.Rate of deterioration in NF was measured as estimated percentage of participants using Kaplan-Meier method.

Preservation of NF was defined as a decrease of \<=1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain).

Preservation of NF was defined as a decrease of less than or equal to (\<=) 1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain).

The correlation between recurrence (local, distant or overall) \& NF was assessed by presenting change in NF domain scores (memory domain \[MD\], executive function domain \[EFD\], fine motor coordination domain \[FMCD\]) after tumor recurrence (Visits X, X+1, X+2, and X+3) compared to before tumor recurrence (Visit X-1). Here 'Visit X' refers to visit at which participants had tumor recurrence, Visit X-1 refers to visit immediately before the recurrence and X+1, X+2, X+3 refers to subsequent first, second \& third visit after the recurrence.NF domain z-scores were derived from participant's scores in individual neurocognitive tests using an age-adjusted \&education-adjusted normative distribution of scores from an unimpaired population. Individual z-scores from related tests were averaged to determine overall z-score for each of NF domains.

Neurologic Death was defined as death due to progression of neurologic disease.

The time to neurocognitive deterioration was defined as the number of days between the date of study treatment and the date of neurocognitive deterioration based on NF assessment. This was assessed using Kaplan Meier method.

Neurocognitive decline was defined as any decrease in NF scores less than (\<) 0 SD from baseline. Here, in category titles EFD represents Executive Function Domain and FMCD represents Fine Motor Coordination Domain.

Eisai Inc.

The study team only has access to serious and all treatment-emergent adverse events (serious and non-serious). All efforts to locate other adverse event data have been exhausted. All treatment-emergent adverse events, whether serious or non-serious, have been reported in the Other (Not Including Serious) Adverse Events tables as severity of the event cannot be distinguished in available data.

Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 mg of carmustine). Participants were followed up to 12 months or until the participant experienced local recurrence, withdrew, died, was lost to follow-up, or the study was closed.

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The safety analysis set included all enrolled participants who underwent surgical resection and received GLIADEL treatment.

Eisai Medical Services

Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 mg of carmustine).

The per protocol 1 (PP1) population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example whole brain radiation therapy \[WBRT\]) before recurrence.

Rate of Deterioration in Neurocognitive Functioning (NF) at Month 12

Domains preserved=3

Domains preserved=2

Domains preserved=1

Domains preserved=0

The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence.

Number of Participants With Neurocognitive Domains Preserved at Month 2

Number of Participants With Neurocognitive Domains Preserved at Month 4

Number of Participants With Neurocognitive Domains Preserved at Month 6

Number of Participants With Neurocognitive Domains Preserved at Month 9

Number of Participants With Neurocognitive Domains Preserved at Month 12

Local Recurrence

Distant Recurrence

Overall Recurrence

Percentage of Participants With Brain Tumor Recurrence (Local Recurrence, Distant Recurrence and Overall Recurrence)

Time to Local Recurrence

Time to Distant Recurrence

Time to Overall Recurrence

Time to Recurrence (Local, Distant and Overall)

PP1 population. Since only two participants had residual tumor mass, no correlation analyses were performed for recurrence and residual mass effect.

Correlation of Tumor Recurrence With Residual Mass Effect

Local Recurrence: MD at Visit (X-1)

Local Recurrence: MD Change at Visit (X-1)

Local Recurrence: MD Change at Visit (X+1)

Local Recurrence: MD Change at Visit (X+2)

Local Recurrence: MD Change at Visit (X+3)

Local Recurrence: EFD at Visit (X-1)

Local Recurrence: EFD Change at Visit (X-1)

Local Recurrence: EFD Change at Visit (X+1)

Local Recurrence: EFD Change at Visit (X+2)

Local Recurrence: EFD Change at Visit (X+3)

Local Recurrence: FMCD at Visit (X-1)

Local Recurrence: FMCD Change at Visit (X-1)

Local Recurrence: FMCD Change at Visit (X+1)

Local Recurrence: FMCD Change at Visit (X+2)

Local Recurrence: FMCD Change at Visit (X+3)

Distant Recurrence: MD at Visit (X-1)

Distant Recurrence: MD Change at Visit (X-1)

Distant Recurrence: MD Change at Visit (X+1)

Distant Recurrence: MD Change at Visit (X+2)

Distant Recurrence: MD Change at Visit (X+3)

Distant Recurrence: EFD at Visit (X-1)

Distant Recurrence: EFD Change at Visit (X-1)

Distant Recurrence: EFD Change at Visit (X+1)

Distant Recurrence: EFD Change at Visit (X+2)

Distant Recurrence: EFD Change at Visit (X+3)

Distant Recurrence: FMCD at Visit (X-1)

Distant Recurrence: FMCD Change at Visit (X-1)

Distant Recurrence: FMCD Change at Visit (X+1)

Distant Recurrence: FMCD Change at Visit (X+2)

Distant Recurrence: FMCD Change at Visit (X+3)

Overall Recurrence: MD at Visit (X-1)

Overall Recurrence: MD Change at Visit (X-1)

Overall Recurrence: MD Change at Visit (X+1)

Overall Recurrence: MD Change at Visit (X+2)

Overall Recurrence: MD Change at Visit (X+3)

Overall Recurrence: EFD at Visit (X-1)

Overall Recurrence: EFD Change at Visit (X-1)

Overall Recurrence: EFD Change at Visit (X+1)

Overall Recurrence: EFD Change at Visit (X+2)

Overall Recurrence: EFD Change at Visit (X+3)

Overall Recurrence: FMCD at Visit (X-1)

Overall Recurrence: FMCD Change at Visit (X-1)

Overall Recurrence: FMCD Change at Visit (X+1)

Overall Recurrence: FMCD Change at Visit (X+2)

Overall Recurrence: FMCD Change at Visit (X+3)

Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores

Percentage of Participants With Neurologic Death

Time to Neurocognitive Deterioration

Month 2: Memory Domain, decline <0 to -1 SD

Month 2: Memory Domain, decline <-1 to -2 SD

Month 2: Memory Domain, decline <-2 to -3 SD

Month 2: Memory Domain, decline <-3 to -4 SD

Month 2: Memory Domain, decline <-4 to -5 SD

Month 2: Memory Domain, decline <-5 SD

Month 2: EFD, decline <0 to -1 SD

Month 2: EFD, decline <-1 to -2 SD

Month 2: EFD, decline <-2 to -3 SD

Month 2: EFD, decline <-3 to -4 SD

Month 2: EFD, decline <-4 to -5 SD

Month 2: EFD, decline <-5 SD

Month 2: FMCD, decline <0 to -1 SD

Month 2: FMCD, decline <-1 to -2 SD

Month 2: FMCD, decline <-2 to -3 SD

Month 2: FMCD, decline <-3 to -4 SD

Month 2: FMCD, decline <-4 to -5 SD

Month 2: FMCD, decline <-5 SD

Month 4: Memory Domain, decline <0 to -1 SD

Month 4: Memory Domain, decline <-1 to -2 SD

Month 4: Memory Domain, decline <-2 to -3 SD

Month 4: Memory Domain, decline <-3 to -4 SD

Month 4: Memory Domain, decline <-4 to -5 SD

Month 4: Memory Domain, decline <-5 SD

Month 4: EFD, decline <0 to -1 SD

Month 4: EFD, decline <-1 to -2 SD

Month 4: EFD, decline <-2 to -3 SD

Month 4: EFD, decline <-3 to -4 SD

Month 4: EFD, decline <-4 to -5 SD

Month 4: EFD, decline <-5 SD

Month 4: FMCD, decline <0 to -1 SD

Month 4: FMCD, decline <-1 to -2 SD

Month 4: FMCD, decline <-2 to -3 SD

Month 4: FMCD, decline <-3 to -4 SD

Month 4: FMCD, decline <-4 to -5 SD

Month 4: FMCD, decline <-5 SD

Month 6: Memory Domain, decline <0 to -1 SD

Month 6: Memory Domain, decline <-1 to -2 SD

Month 6: Memory Domain, decline <-2 to -3 SD

Month 6: Memory Domain, decline <-3 to -4 SD

Month 6: Memory Domain, decline <-4 to -5 SD

Month 6: Memory Domain, decline <-5 SD

Month 6: EFD, decline <0 to -1 SD

Month 6: EFD, decline <-1 to -2 SD

Month 6: EFD, decline <-2 to -3 SD

Month 6: EFD, decline <-3 to -4 SD

Month 6: EFD, decline <-4 to -5 SD

Month 6: EFD, decline <-5 SD

Month 6: FMCD, decline <0 to -1 SD

Month 6: FMCD, decline <-1 to -2 SD

Month 6: FMCD, decline <-2 to -3 SD

Month 6: FMCD, decline <-3 to -4 SD

Month 6: FMCD, decline <-4 to -5 SD

Month 6: FMCD, decline <-5 SD

Month 9: Memory Domain, decline <0 to -1 SD

Month 9: Memory Domain, decline <-1 to -2 SD

Month 9: Memory Domain, decline <-2 to -3 SD

Month 9: Memory Domain, decline <-3 to -4 SD

Month 9: Memory Domain, decline <-4 to -5 SD

Month 9: Memory Domain, decline <-5 SD

Month 9: EFD, decline <0 to -1 SD

Month 9: EFD, decline <-1 to -2 SD

Month 9: EFD, decline <-2 to -3 SD

Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Feasibility Study of Image Guided Noninvasive Single Fraction Stereotactic Radiosurgery for the Treatment of Brain Metastases	NCT00610285	Metastatic Brai...	Fabrication of ...	18 Years -	Memorial Sloan Kettering Cancer Center
ExAblate (Magnetic Resonance-guided Focused Ultrasound Surgery) Treatment of Brain Tumors	NCT01473485	Glioma Metastatic Brai...	ExAblate Transc...	18 Years - 75 Years	InSightec
Study of 111In-DAC as an Medical Imaging Agent for Lung Cancer and Brain Cancer Consistent With Metastatic Lung Cancer	NCT00040560	Lung Neoplasms Carcinoma, Non-... Brain Neoplasms Metastases, Neo...	111In-DAC Diagnostic	18 Years -	Copharos
Exploratory Study, Evaluating the Treatment Effect of Surgery Plus GLIADEL® Wafer in Patients With Metastatic Brain Cancer	NCT00525590	Metastatic Brai...	GLIADEL	18 Years -	Eisai Inc.
Phase II Trial of Conventional Versus IMRT Whole Brain Radiotherapy for Brain Metastases	NCT01890278	Metastatic Brai...	Whole Brain IMR... Conventional Wh...	18 Years -	Good Samaritan Hospital Medical Center, New York
Developing a New MRI Technique to Understand Changes in Brain Tumors After Treatment	NCT05559853	Brain Metastase... Brain Metastase... Metastatic Brai... Metastatic Brai...	CEST-MRF	18 Years -	Memorial Sloan Kettering Cancer Center
Investigating the Efficacy of Hair Sparing Radiotherapy Treatment to the Whole Brain.	NCT02213536	Metastatic Brai...	VMAT (Volumetri...	18 Years -	HCA International Limited
A Feasibility Study of Image Guided Noninvasive Single Fraction Stereotactic Radiosurgery for the Treatment of Brain Metastases	NCT00610285	Metastatic Brai...	Fabrication of ...	18 Years -	Memorial Sloan Kettering Cancer Center
Investigating the Efficacy of Hair Sparing Radiotherapy Treatment to the Whole Brain.	NCT02213536	Metastatic Brai...	VMAT (Volumetri...	18 Years -	HCA International Limited

Spots Global Cancer Trial Database for metastatic brain cancer