MR-Guided High Intensity Focused Ultrasound for Pain Management Of Osteoid Osteoma & Benign Bone Tumors in Children and Adults
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02618369|
Recruitment Status : Unknown
Verified October 2016 by James Drake, The Hospital for Sick Children.
Recruitment status was: Recruiting
First Posted : December 1, 2015
Last Update Posted : October 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Osteoid Osteoma Benign Bone Tumor Pain||Device: MR-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 Pain Management of Osteoid Osteoma and Benign Bone Tumors in Children and Young Adults|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||October 2018|
The interventional radiologist will locate the target lesion 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.
Device: MR-Guided High Intensity Focused Ultrasound
Target treatment of bone lesion using High Intensity Focused Ultrasound
- Change in pain intensity scores from baseline related to the site treated target lesion. [ 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 after treatment.
- Reduction in in pain medication usage (NSAIDS, Opioids). [ Time Frame: 2, 7, 14, 30 and 90 days following treatment. ]As noted in pain diaries by patient before and day 2, 7. 14, 30 and 90 days after 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): NCT02618369
|Contact: James M Drake, FRCSCemail@example.com|
|Contact: Maria Lamberti-Pasculli, RNfirstname.lastname@example.org|
|The Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada, M5G 1X8|
|Contact: James M Drake, FRCSC. FACS 416-813-6125 email@example.com|
|Contact: Maria Lamberti-Pasculli, RN 416-813-6456 firstname.lastname@example.org|
|Principal Investigator:||James M Drake, FRCSC, FACS||The Hospital for Sick Children|