Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06185972
Status:
RECRUITING
Last Update Posted:
2023-12-29
First Post:
2023-12-15
Brief Title:
Novel Magnetic Resonance Imaging-Guided Ultrasound-Stimulated Microbubble Radiation Treatment for Patients With Chest-Wall and Breast Cancer
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Novel Magnetic Resonance Imaging-Guided Ultrasound-Stimulated Microbubble Radiation Treatment for Patients With Chest-Wall and Locally Advanced Breast Cancer-Phase II
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to demonstrate the efficacy and response of novel Magnetic Resonance Imaging MRI-guided ultrasound stimulated microbubble treatment to enhance radiation effects in humans receiving external beam radiotherapy delivered using a LINAC linear accelerator radiation therapy device
Detailed Description:
The approach uses relatively low-power ultrasound operating with lower power levels than high intensity focused ultrasound and ultrasound-based hyperthermia techniques delivered on the Sonalleve platform The tumour will be sonicated before the radiation to enhance the effect of therapy The technique is spatially targeted and stimulates microbubbles using low-power ultrasonic fields in the tumour location only The primary aim is to evaluate tumour response to MRg-FUS MB and radiation as measured radiologically or clinically within the treated therapeutic target regionsThe secondary aim of this research is to evaluate early and late effect profiles of MRI- guided ultrasound stimulated microbubble treatment and radiation in patients with inoperable breastchest wall tumours or LABC at 1 day 1 week 2 weeks 1 month 3 months 6 months and 1 year after treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None