Ignite Creation Date:
2024-05-06 @ 11:01 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03404362
Status:
COMPLETED
Last Update Posted:
2022-02-17
First Post:
2018-01-11
Brief Title:
MRgFUS Versus EBRT in Patients With Metastatic Non-spinal Bone Disease
Sponsor:
University of Roma La Sapienza
Organization:
University of Roma La Sapienza
Study Overview
Official Title:
A Two-center Phase II Non-randomized Study of MRgFUS Versus EBRT in Patients With Metastatic Non-spinal Bone Disease Palliative Strategy for Cancer-Induced Bone Pain
Status:
COMPLETED
Status Verified Date:
2022-02
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 trial is to collect and compare safety and effectiveness data of Magnetic Resonance guided Focused Ultrasound MRgFUS using the ExAblate 2100 device and radiotherapy in the treatment of metastatic bone tumors
This study is designed as a prospective double arm non-randomized study with External Beam radiation therapy EBRT serving as control arm
The study hypothesis is that MRgFUS is an effective non-invasive and safe treatment for the palliation of metastatic bone tumors with a low incidence of co-morbidity as compared to EBRT
This study is designed as a prospective double arm non-randomized study with External Beam radiation therapy EBRT serving as control arm
The study hypothesis is that MRgFUS is an effective non-invasive and safe treatment for the palliation of metastatic bone tumors with a low incidence of co-morbidity as compared to EBRT
Detailed Description:
This is a prospective phase II open-label non-randomized double arm study to collect data on safety and effectiveness of ExAblate MRgFUS and EBRT treatments of metastatic bone tumors Following treatment assignment and treatment itself subjects will be followed for up for 12 months to evaluate pain relief as well as quality of life Additional data regarding dosage and frequency of analgesic consumption for the management of the bone tumor induced pain will also be collected MRI of the treated lesion will be obtained 3 and 6 months post therapy to evaluate effect on the lesion in both radiation and MRgFUS arms This is clinically acceptable and widely utilized diagnostic method in follow up of this patient population
Data will be collected for a total of 184 patients 92 patients treated by EBRT and another 92 patients treated by FUS
Treating physician as of hisher normal practice might offer additional treatment of other type in cases where pain score of the treated lesion will not improve by at least 2 points and will remain 4 or greater Additional treatment may be performed up to one month following treatment Prior to offering alternative treatment an MRI will be performed to evaluate effect on the lesion Patient receiving another treatment different from the initial one ie patient initially treated with FUS is now treated by EBRT will be considered as treatment failures for the primary analysis and their post-x-over follow-up results will be analyzed separately
Data will be collected for a total of 184 patients 92 patients treated by EBRT and another 92 patients treated by FUS
Treating physician as of hisher normal practice might offer additional treatment of other type in cases where pain score of the treated lesion will not improve by at least 2 points and will remain 4 or greater Additional treatment may be performed up to one month following treatment Prior to offering alternative treatment an MRI will be performed to evaluate effect on the lesion Patient receiving another treatment different from the initial one ie patient initially treated with FUS is now treated by EBRT will be considered as treatment failures for the primary analysis and their post-x-over follow-up results will be analyzed separately
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