ExAblate Blood-Brain Barrier Disruption for Glioblastoma in Patients Undergoing Standard Chemotherapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03712293|
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme||Device: BBB Disruption with Chemotherapy Arm||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This study will enroll up to 10 patients who are eligible and recommended for the standard adjuvant phase of TMZ chemotherapy. The goal is for all subjects to undergo ExAblate Type 2.0 BBB disruption procedures on one of the first three days of each TMZ dosing cycle throughout the adjuvant phase (up to 6 cycles).|
|Masking:||None (Open Label)|
|Official Title:||Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier Disruption for the Treatment of Glioblastoma in Patients Undergoing Standard Chemotherapy|
|Actual Study Start Date :||August 28, 2018|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: BBB Disruption with Chemotherapy Arm
All subjects in this arm will undergo ExAblate Type 2.0 BBBD procedures on one of the first three days of each TMZ dosing cycle throughout the adjuvant phase (up to 6 cycles).
Device: BBB Disruption with Chemotherapy Arm
The ExAblate BBB disruption of targets associated with enhancing post-resection MRI imaging procedure will be performed with ExAblate 4000 type 2.0 system and will coincide with on one of three first days of each planned TMZ adjuvant therapy cycle as one procedure per cycle.
- Adverse Events Safety Profile [ Time Frame: 7 months ]The type and severity of adverse events post-procedure will be assessed for overall safety. Safety of the BBBD procedure will be evaluated through patient examination and MRI assessments during the treatment and by their standard of care follow-up MRI scans and clinical visits. The standard of care follow-up MRI scans will be used to continue safety monitoring post-BBBD procedures and after adjuvant TMZ chemotherapy is completed.
- Blood Brain Barrier Opening [ Time Frame: 7 months ]The ability to open the Blood Brain Barrier with ExAblate Focused Ultrasound will be evaluated by contrast MR imaging. If the procedure was successful, the area treated with show contrast enhancement on MRI.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712293
|Contact: Martin Bernstein||+97248131313 ext firstname.lastname@example.org|
|Contact: Kathy L McDermott||+12146302000|
|Korea, Republic of|
|Severance Hospital, Yonsei University Health System||Recruiting|
|Seoul, Seodaemun-gu, Korea, Republic of, 03722|
|Contact: Eunjung Kweon, RN +82-2-2224-4578 KWEONEJ@yuhs.ac|
|Contact: Jiseon Oh +82-2-2228-0478 WLTJS1828@yuhs.ac|
|Principal Investigator: JinWoo Chang, MD, PhD|
|Sub-Investigator: Jong Hee Chang, MD, PhD|
|Sub-Investigator: Hyun Ho Jung, MD, PhD|
|Sub-Investigator: Na Young Jung, MD, PhD|
|Sub-Investigator: Il Jang, MD, PhD|
|Study Director:||Martin Bernstein||InSightec|