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Magnetic Resonance Guided High Intensity Focused Ultrasound (MRgHIFU) for Pain Palliation of Bone Metastases (HIFU-Bone)

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ClinicalTrials.gov Identifier: NCT03479151
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : August 8, 2018
Sponsor:
Collaborators:
Philips Medical Systems
Cancer Research UK
Information provided by (Responsible Party):
Nandita deSouza, Institute of Cancer Research, United Kingdom

Tracking Information
First Submitted Date  ICMJE February 27, 2018
First Posted Date  ICMJE March 27, 2018
Last Update Posted Date August 8, 2018
Actual Study Start Date  ICMJE March 16, 2018
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
Measure the ablated tissue volume indicated by immediate post-treatment Gd-T1W imaging in responders and non-responders. [ Time Frame: Day 30 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03479151 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
  • To report the treatment response rate. [ Time Frame: up to 90 days ]
    Days 7, 14, 30, 60 and 90
  • To investigate whether ablated tissue volume indicated by Gd-T1W imaging at Day 30 remains stable at Days 60 and 90. [ Time Frame: up to 90 days ]
  • .To investigate whether intra-procedural PRFS metrics are different in responders and non-responders at Day 30 [ Time Frame: 30 days post treatment ]
    PRFS Metrics include thermal dose volume, temperature
  • To investigate whether intra- or post-procedural changes in ADC are different in responders and non-responders. [ Time Frame: Day 30 ]
  • To investigate whether intra- or post-procedural changes in T2 are different in responders and non-responders. [ Time Frame: Day 30 ]
  • The rate of treatment-related adverse events [ Time Frame: up to 3 months after treatment. ]
  • The effect of MRgHIFU treatment on patients' quality of life, recorded using Quality of Life Questionnaires (QLQ's). [ Time Frame: up to 3 months after treatment. ]
    using EORTC (European Organization for Research and Treatment of Cancer)- QLQ's
  • The costs of MRgHIFU treatment. [ Time Frame: up to 3 months after treatment. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Magnetic Resonance Guided High Intensity Focused Ultrasound (MRgHIFU) for Pain Palliation of Bone Metastases
Official Title  ICMJE Magnetic Resonance Guided High Intensity Focused Ultrasound (MRgHIFU) for Pain Palliation of Bone Metastases
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 painful bone metastases, who wish to consider MRgHIFU treatment. These patients will be identified in conjunction with the pain and palliative care teams, as well as clinical and medical oncologists. Patients will undergo MRgHIFU treatment using scanning and treatment planning methods that have been established in the patients treated within the multi-centre study. The treatment response rate for the cohort will be recorded. Intra- and post-procedural imaging metrics will be evaluated for their ability to detect tissue changes, which may be indicative of response. Patients will be followed-up for up to 90 days after treatment, and will attend for repeat imaging and pain review at days 30, 60 and 90 after treatment. Any changes in imaging metrics will be compared between responders and non-responders.
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 after treatment.

The secondary aims of this study are:

  • To record the proportion of patients responding to MRgHIFU treatment at Days 7, 14, 30, 60 and 90 after treatment
  • To investigate whether intra-procedural PRFS metrics (thermal dose volume, temperature) are indicative of subsequent treatment response
  • To investigate whether intra- or post-procedural changes in ADC or T2 are indicative of subsequent treatment response
  • To record adverse events arising as a result of MRgHIFU treatment
  • To evaluate the effect of MRgHIFU treatment on patients' quality of life
  • To record the time to pain progression and the duration of pain response for patients in this cohort
  • To estimate the costs of MRgHIFU treatment

This is an exploratory study, which will recruit n=15 patients into one single cohort. Enrolment of the target population for the study is expected to take approximately 2 years. Patients will be eligible for the study if they wish to consider MRgHIFU treatment for pain palliation of a region of bony metastatic disease that is accessible to the MRgHIFU device. After providing their written informed consent to participate in the study, patients' suitability for treatment will be determined by a combined assessment of clinical review by a pain specialist, and an MR screening investigation to establish lesion targetability. Baseline clinical and imaging metrics will be recorded. Patients who fulfill all inclusion criteria, have none of the exclusion criteria, and who give informed consent, will be scheduled for MRgHIFU treatment to the target lesion. Treatment will be delivered under sedation on a day-case basis, according to protocols already established in our prior study. During treatment delivery, the investigators will assess imaging metrics of tissue change, which may be indicative of subsequent treatment response. Treatment would be expected to take approximately 1-2 hours, and after an observation period of approximately 2-4 hours, the patient will be discharged. Before discharge, follow-up instructions will be given to the patient. Patients' clinical and imaging responses to treatment will then be assessed at follow-up appointments up to 3 months after treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Bone Metastases
Intervention  ICMJE Device: Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)
MRgHIFU treatment will be delivered using a Philips Sonalleve system, which integrates a high intensity phased array focused ultrasound transducer with our Philips 3T Achieva imaging system. An electromechanical transducer positioning system is used to deliver spatially and temporally controlled ultrasound energy and thermal heat to tissues non-invasively. The MR system is used to provide images to plan the therapy, and to guide and monitor the thermal ablation with thermal imaging during the treatment.
Study Arms  ICMJE Experimental: MR-HIFU of painful bone metastases
Magnetic Resonance guided High Intensity Focused Ultrasound (MRgHIFU) for Pain Palliation of Bone Metastases
Intervention: Device: Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 20, 2018)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nandita deSouza, Professor 0208 661 3289 nandita.desouza@icr.ac.uk
Contact: Katherine May, BSc 02089156624 katherine.may@rmh.nhs.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03479151
Other Study ID Numbers  ICMJE 17/LO/1689 CCR 4733
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nandita deSouza, Institute of Cancer Research, United Kingdom
Study Sponsor  ICMJE Institute of Cancer Research, United Kingdom
Collaborators  ICMJE
  • Philips Medical Systems
  • Cancer Research UK
Investigators  ICMJE
Principal Investigator: Nandita deSouza, Professor Institute of Cancer Research, United Kingdom
PRS Account Institute of Cancer Research, United Kingdom
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP