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

InSightec1 site in 1 country10 target enrollmentOctober 2014

ConditionsBrain Tumor

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Brain Tumor
Sponsor: InSightec
Enrollment: 10
Locations: 1
Primary Endpoint: Number of Device and Procedure related adverse events
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

December 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

InSightec

Responsible Party

Sponsor

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-
•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