NCT02343991

Brief Summary

The purpose of this study is to evaluate the safety of BBB disruption using transcranial MRI-guided focused ultrasound in conjunction with an intravenous ultrasound contrast agent to increase the accumulation of doxorubicin in brain tumours and the adjacent brain using the ExAblate Transcranial system (220 kHz). Data will be collected to establish the basic safety of this type of treatment as the basis for later studies to 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
6mo left

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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%
Oct 2014Dec 2026

Study Start

First participant enrolled

October 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 22, 2015

Completed
11.9 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

12.2 years

First QC Date

January 12, 2015

Last Update Submit

April 30, 2025

Conditions

Brain Tumor

Outcome Measures

Primary Outcomes (1)

  • Number of Device and Procedure related adverse events

    To evaluate the incidence and severity of adverse events (AEs) associated with the ExAblate transcranial treatment

    At the time of ExAblate transcranial procedure

Secondary Outcomes (1)

  • Severity of Device and Procedure related adverse events

    At the time of ExAblate transcranial procedure

Study Arms (1)

Transcranial ExAblate

EXPERIMENTAL

MR Guided Focused Ultrasound

Device: Transcranial ExABlate

Interventions

Transcranial ExABlateDEVICE

MR Guided Focused Ultrasound

Also known as: ExAblate, TcMRgFUS
Transcranial ExAblate

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.
  • Size of the targeted portion of the tumour (i.e. prescribed ROT) is less than 2.5 cm in diameter (16 cm3). The non-targeted tumour tissue may exceed the targeted volume.
  • Karnofsky rating 70-100
  • ASA score 1-3.
  • 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.

You may not qualify if:

  • The sonication pathway to the tumour involves:
  • i. More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp ii. Clips or other metallic implanted objects in the skull or the brain, except shunts
  • The subject presents with symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papilledema)
  • Cardiac disease or unstable hemodynamics including:
  • i. Documented myocardial infarction within six months of enrolment ii. Unstable angina on medication iii. Congestive heart failure iv. Left ventricular ejection fraction below the lower limit of normal v. History of a hemodynamically unstable cardiac arrythmia vi. Cardiac pacemaker
  • Severe hypertension (diastolic BP \> 100 on medication)
  • Anti-coagulant therapy, or medications known to increase risk of hemorrhage, (e.g.:ASA, non-steroidal anti-inflammatory drugs (NSAIDs), statins)
  • History of a bleeding disorder, coagulopathy or with a history of spontaneous tumour hemorrhage
  • Abnormal level of platelets (\< 100000), PT (\>14) or PTT (\>36), and INR \> 1.3
  • Documented cerebral infarction within the past 12 months
  • TIA in the last 1 month
  • Cerebral or systemic vasculopathy
  • Insulin-dependent diabetes mellitus
  • Immunosuppression (corticosteroids to prevent/treat brain edema are permitted)
  • Known sensitivity to gadolinium-DTPA
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

  • Mainprize T, Lipsman N, Huang Y, Meng Y, Bethune A, Ironside S, Heyn C, Alkins R, Trudeau M, Sahgal A, Perry J, Hynynen K. Blood-Brain Barrier Opening in Primary Brain Tumors with Non-invasive MR-Guided Focused Ultrasound: A Clinical Safety and Feasibility Study. Sci Rep. 2019 Jan 23;9(1):321. doi: 10.1038/s41598-018-36340-0.

    PMID: 30674905DERIVED

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

January 12, 2015

First Posted

January 22, 2015

Study Start

October 1, 2014

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 1, 2025

Record last verified: 2025-04

Locations

CA(1)