Status:
WITHDRAWN
Magnetic Resonance Guided High Intensity Focused Ultrasound (MRgHIFU) for Pain Palliation of Bone Metastases
Lead Sponsor:
Institute of Cancer Research, United Kingdom
Collaborating Sponsors:
Philips Medical Systems
Cancer Research UK
Conditions:
Cancer
Bone Metastases
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The primary objective of this study is to determine whether intra- and post-procedural MR changes are indicative of reduction in pain symptom scores. The trial will recruit a cohort of patients with p...
Detailed Description
The primary aim of this study is to investigate whether the ablated tissue volume indicated by immediate post-treatment Gd-T1W imaging is indicative of reduction in pain scores (response) 30 days afte...
Eligibility Criteria
Inclusion
- Patients with painful bony metastatic disease
- Target bony metastatic lesion is painful (NRS≥4)
- Intended target region accessible for MRgHIFU treatment (usually not skull or spinal metastases above the sacrum)
- Intended target region visible on non-contrast MR imaging
Exclusion
- MRI contra-indicated (e.g. by incompatible metal implants, claustrophobia, or because BMI precludes accommodation in the MR scanner)
- Pregnancy
- Sedation contra-indicated
- Critical anatomical structure cannot be avoided along the beam path or the at the target (can be assessed at screening)
- Internal or external fixation device along the beam path or at the target
Key Trial Info
Start Date :
March 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03479151
Start Date
March 16 2018
End Date
January 7 2021
Last Update
October 8 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT