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

NCT03479151 | Withdrawn DMC

• 1 other identifier: 17/LO/1689 CCR 4733
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Bone Metastases

Keywords

Magnetic Resonance Imaging (MRI); High Intensity Focused Ultrasound (HIFU)

Outcome Measures

Primary Outcomes (1)

• Measure the ablated tissue volume indicated by immediate post-treatment Gd-T1W imaging in responders and non-responders.

  Day 30

Secondary Outcomes (8)

• To report the treatment response rate.

  up to 90 days

• To investigate whether ablated tissue volume indicated by Gd-T1W imaging at Day 30 remains stable at Days 60 and 90.

  up to 90 days

• .To investigate whether intra-procedural PRFS metrics are different in responders and non-responders at Day 30

  30 days post treatment

• To investigate whether intra- or post-procedural changes in ADC are different in responders and non-responders.

  Day 30

• To investigate whether intra- or post-procedural changes in T2 are different in responders and non-responders.

  Day 30

Study Arms (1)

MR-HIFU of painful bone metastases

EXPERIMENTAL

Magnetic Resonance guided High Intensity Focused Ultrasound (MRgHIFU) for Pain Palliation of Bone Metastases

Device: Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)

Interventions

Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU) DEVICE

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.

MR-HIFU of painful bone metastases

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead
• Philips Medical Systems: collaborator
• Cancer Research UK: collaborator

Study Sites (1)

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Nandita deSouza, Professor

  Institute of Cancer Research, United Kingdom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Nandita Da Souza

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 27, 2018
• Study Start: March 16, 2018
• Primary Completion: January 7, 2021
• Study Completion: January 7, 2021
• Last Updated: October 8, 2021

Record last verified: 2021-10

Locations

GB (1)