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Blood-Brain Barrier Disruption Using Transcranial MRI-Guided Focused Ultrasound

Primary Purpose

Brain Tumor

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Transcranial ExABlate

About this trial

This is an interventional treatment trial for Brain Tumor

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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
Contraindications to MRI such as non-MRI-compatible implanted devices
Large subjects not fitting comfortably into the MRI scanner (generally >250 lbs)
Difficulty lying 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
Severely impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2 and/or on dialysis
Right to left or bi-directional cardiac shunt
Previous full course of doxorubicin chemotherapy
Allergy to eggs or egg products

Sites / Locations

Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcranial ExAblate

Arm Description

MR Guided Focused Ultrasound

Outcomes

Primary Outcome Measures

Number of Device and Procedure related adverse events

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

Secondary Outcome Measures

Severity of Device and Procedure related adverse events

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

Full Information

NCT ID

NCT02343991

First Posted

January 12, 2015

Last Updated

September 7, 2021

Sponsor

InSightec

1. Study Identification

Unique Protocol Identification Number

NCT02343991

Brief Title

Blood-Brain Barrier Disruption Using Transcranial MRI-Guided Focused Ultrasound

Official Title

A Study to Evaluate the Safety and Feasibility of Blood-Brain Barrier Disruption Using Transcranial MRI-Guided Focused Ultrasound With Intravenous Ultrasound Contrast Agents in the Treatment of Brain Tumours With Doxorubicin

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 2014 (undefined)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

InSightec

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Tumor

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Transcranial ExAblate

Arm Type

Experimental

Arm Description

MR Guided Focused Ultrasound

Intervention Type

Device

Intervention Name(s)

Transcranial ExABlate

Other Intervention Name(s)

ExAblate, TcMRgFUS

Intervention Description

MR Guided Focused Ultrasound

Primary Outcome Measure Information:

Title

Number of Device and Procedure related adverse events

Description

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

Time Frame

At the time of ExAblate transcranial procedure

Secondary Outcome Measure Information:

Title

Severity of Device and Procedure related adverse events

Description

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

Time Frame

At the time of ExAblate transcranial procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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 Contraindications to MRI such as non-MRI-compatible implanted devices Large subjects not fitting comfortably into the MRI scanner (generally >250 lbs) Difficulty lying 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 Severely impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2 and/or on dialysis Right to left or bi-directional cardiac shunt Previous full course of doxorubicin chemotherapy Allergy to eggs or egg products

Facility Information:

Facility Name

Sunnybrook Health Sciences Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

30674905

Citation

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.

Results Reference

derived

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Blood-Brain Barrier Disruption Using Transcranial MRI-Guided Focused Ultrasound

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