NCT00147056

Brief Summary

The purpose of this study is to evaluate the safety of MRI-guided focused ultrasound thermal ablation of brain tumors performed through intact human skull using the ExAblate transcranial system. We will collect data to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its clinical efficacy.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Aug 2012Dec 2026

First Submitted

Initial submission to the registry

September 2, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
6.9 years until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
14.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

14.3 years

First QC Date

September 2, 2005

Last Update Submit

April 30, 2025

Conditions

Brain Tumor

Keywords

Brain tumorBrain LesionsBrain CancerExAblate

Outcome Measures

Primary Outcomes (1)

  • Number of subjects with Serious and Non-Serious Adverse Events after MRI Guided Focused ultrasound treatment for brain tumors

    To evaluate the safety of ExAblate TcMRgFUS treatment delivered through intact human skull to the brain, during the treatment and during the follow-up period of 3 months.

    Up to 3 months

Study Arms (1)

ExAblate transcranial system

EXPERIMENTAL

MR Guided Focused Ultrasound

Device: ExAblate transcranial system

Interventions

ExAblate transcranial systemDEVICE

MRI-Guided Focused Ultrasound Feasibility Study for Brain

ExAblate transcranial system

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women.
  • Age between 18 and 70 years, inclusive.
  • Able and willing to give informed consent.
  • Subjects with (newly diagnosed or recurrent) metastatic cancer for whom surgery, radiation, or radiosurgery has not been advised by the treating physician.
  • The targeted tumor tissue is located in the cerebral hemispheres, \> 2.5 cm from the inner table of the skull. Non-targeted parts of the tumor may extend outside the treated tumor limits.
  • Tumor(s) are clearly defined on pre-therapy contrast enhanced MRI scans.
  • Size of the targeted portion of the tumor (i.e. prescribed Region Of Treatment) is less than 2.5 cm in diameter or 8 cm3 in volume. The non-targeted tumor tissue may exceed the targeted volume.
  • Karnofsky rating 70-100 (See Appendix A).
  • ASA score 1-2.
  • Able to communicate sensations during the ExAblate MRGFUS procedure.
  • Able to attend all study visits (i.e. life expectancy of at least 3 months).
  • At least 14 days passed since last brain surgery, or intracranial radiation therapy/radiosurgery

You may not qualify if:

  • The subject presents with:
  • \- Symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papaedema).
  • \- Unstable hemodynamic status including: i. Documented myocardial infarction within six months of enrollment. ii.Symptomatic coronary artery stenosis. iii. Congestive heart disease requiring medication. iv. Anti-arrhythmic drug medication. v. Cardiac pacemaker. vi. Severe hypertension (diastolic BP \> 100 on medication).
  • Anti-coagulant therapy, on medications known to increase risk of hemorrhage, (e.g.: non-steroidal anti-inflammatory drugs (NSAIDs), statins
  • TIA or stroke in the last 1 month
  • Insulin-dependent diabetes mellitus
  • Immunosuppression (corticosteroids to prevent brain edema are permitted)
  • Known sensitivity to gadolinium-DTPA
  • Contraindications to MRI such as non-MRI-compatible implanted devices
  • Large subjects not fitting comfortably into the MRI scanner
  • Difficulty laying supine and still for up to 4 hours in the MRI unit or claustrophobia
  • Untreated, uncontrolled Sleep apnea
  • Positive pregnancy test (for pre-menopausal women)
  • Known life-threatening systemic disease
  • More than 3 metastatic tumors
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Related Links

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 7, 2005

Study Start

August 1, 2012

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 1, 2025

Record last verified: 2025-04

Locations

US(2)