MRI Guided HIFU for Palliation of Painful Skeletal Metastases in Children
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|ClinicalTrials.gov Identifier: NCT02616016|
Recruitment Status : Recruiting
First Posted : November 26, 2015
Last Update Posted : November 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bone Metastases Pain||Device: MRI Guided High Intensity Focused Ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases in Children - A Pilot Study|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
MRI guided High Intensity Focused Ultrasound Treatment
Intervention Group The interventional radiologist will locate the target tissue and mark the volume to be treated using MRI images.
The operator starts the treatment and monitors the progress of the treatment with MR thermal and dose maps to ensure adherence to treatment plan.
An individual treatment sonication will last approximately 30 seconds.
Device: MRI Guided High Intensity Focused Ultrasound
Target treatment of bone metastases using High Intensity Focused Ultrasound
- Change in pain intensity scores from baseline as measured on pain diaries. [ Time Frame: 2, 7, 14, 30 and 90 days following treatment ]As measured on the pain diaries before and at day 2, 7, 14, 30 and 90 days following treatment.
- Improved patient quality of life after MR-HIFU using a quality of life questionnaire. [ Time Frame: 2, 7, 14, 30 and 90 days post treatment ]Using age appropriate quality of life questionnaire that involves interviewing patient and/or parent/guardian before and 2, 7, 14, 30 and 90 days post treatment.
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): NCT02616016
|Contact: James M Drake, FRCSC,FACSemail@example.com|
|Contact: Maria Lamberti-Pasculli, RNfirstname.lastname@example.org|
|Principal Investigator:||James M Drake, FRCSC,FACS||The Hospital for Sick Children|