MRgFUS Versus EBRT in Patients With Metastatic Non-spinal Bone Disease

February 1, 2022 updated by: Alessandro Napoli, University of Roma La Sapienza

A Two-center Phase II, Non-randomized Study of MRgFUS Versus EBRT in Patients With Metastatic Non-spinal Bone Disease: Palliative Strategy for Cancer-Induced Bone Pain

The objective of this trial is to collect and compare safety and effectiveness data of Magnetic Resonance guided Focused Ultrasound (MRgFUS) using the ExAblate 2100 device and radiotherapy in the treatment of metastatic bone tumors.

This study is designed as a prospective, double arm, non-randomized study with External Beam radiation therapy (EBRT) serving as control arm.

The study hypothesis is that MRgFUS is an effective non-invasive and safe treatment for the palliation of metastatic bone tumors with a low incidence of co-morbidity as compared to EBRT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, phase II, open-label, non-randomized, double arm study to collect data on safety and effectiveness of ExAblate MRgFUS and EBRT treatments of metastatic bone tumors. Following treatment assignment and treatment itself, subjects will be followed for up for 12 months to evaluate pain relief as well as quality of life. Additional data regarding dosage and frequency of analgesic consumption for the management of the bone tumor induced pain will also be collected. MRI of the treated lesion will be obtained 3 and 6 months post therapy to evaluate effect on the lesion in both radiation and MRgFUS arms. This is clinically acceptable and widely utilized diagnostic method in follow up of this patient population.

Data will be collected for a total of 184 patients, 92 patients treated by EBRT and another 92 patients treated by FUS.

Treating physician, as of his/her normal practice, might offer additional treatment of other type in cases where pain score of the treated lesion will not improve by at least 2 points, and will remain 4 or greater. Additional treatment may be performed up to one month following treatment. Prior to offering alternative treatment, an MRI will be performed to evaluate effect on the lesion. Patient receiving another treatment, different from the initial one (i.e. patient initially treated with FUS is now treated by EBRT) will be considered as treatment failures for the primary analysis and their post-x-over follow-up results will be analyzed separately.

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00100
        • Alessandro Napoli
      • Rome, Italy
        • Sapienza University of Rome, Policlinico Umberto I Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Men and women age 18 years and older.
  2. Able and willing to give consent and to attend all study visits
  3. Patients with bone metastasis or primary bone lesion identifiable by imaging techniques.
  4. Worst NRS Pain Score of ≥ 4 from the tumor to be treated.
  5. Each targeted tumor is accessible to both ExAblate and EBRT (ExAblate accessible lesions are located in ribs, extremities (excluding joints), pelvis, shoulders and in the posterior aspects of the following spinal vertebra: Lumbar vertebra (L3 - L5), Sacral vertebra (S1 - S5), please see ExAblate "Information for Prescribers".
  6. Targeted tumor area is smaller than 100cm2.
  7. Tumor clearly visible by non-contrast MRI.
  8. No radiation therapy to selected lesion during one month prior to enrollment.
  9. Radiation therapy to selected lesion is not contraindicated
  10. Bisphosphonate, chemo or hormone therapy intake should remain stable throughout follow up duration.

Exclusion Criteria:

  1. Patients who either need pre-treatment surgical stabilization of the affected bony structure
  2. Targeted tumor is in a vertebra body or in the posterior aspects of the vertebral column other than Lumbar vertebra (L3 - L5) and Sacral vertebra (S1 - S5).
  3. Targeted tumor is in the skull.
  4. Patients on anti-coagulation therapy or with an underlying uncontrolled bleeding disorder.
  5. Patients with life expectancy < 6-Months.

  6. Patients with unstable cardiac status including:

    • Unstable angina pectoris on medication.
    • Patients with documented myocardial infarction within last 40 days to protocol entry.
    • Congestive heart failure NYHA Class IV
  7. Severe hypertension (diastolic BP > 100 on medication).
  8. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted ferromagnetic objects/devices.
  9. Known intolerance or allergies to MRI contrast agent (e.g. Gadolinium or Magnevist)
  10. KPS score of below 60
  11. Severe cerebro-vascular disease (multiple CVA or CVA within 6 months)
  12. Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.)
  13. Target tumor is less then 1cm from spinal cord, skin, or hollow viscera.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MRgFUS

The treatment process begins with the physician acquiring a set of MR images, identifying target volume(s) of tissue to ablate, and then drawing the treatment contours.

The therapy planning software computes the type and number of sonications required to treat the defined region while minimizing total treatment time. MR images taken during the sonication provide a diagnostic quality image of the target tissue and a quantitative, real-time temperature map overlay to confirm the therapeutic effect of the treatment
Procedure: Bone Metastases Pain treatment
Comparative treatments to test if MRgFUS is an effective non-invasive and safe treatment for the palliation of metastatic bone tumors with a low incidence of co-morbidity as compared to EBRT (gold-standard)
Active Comparator: EBRT
Patient would undergo single fraction of external beam radiation to a dose of 8Gy or a session of 10 fractions of external beam radiations at 3Gy per fraction for two weeks.
Procedure: Bone Metastases Pain treatment
Comparative treatments to test if MRgFUS is an effective non-invasive and safe treatment for the palliation of metastatic bone tumors with a low incidence of co-morbidity as compared to EBRT (gold-standard)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the effect of MRgFUS in terms of level of pain relief and decrease in analgesics/opiate and improved quality of life.
Time Frame: one month

The key points that this study will capture are as follows:

Capture patient-based pain assessment using a NRS pain scale of 0-10 with anchored points in conjunction with a body diagram, capturing worst and average pain score.

Response rates were defined as follows:

  1. Complete response: NRS of 0 with no concomitant increase in analgesic intake (stable or reduced OMED);
  2. Partial response: a reduction in NRS ≥ 2 points from baseline without an analgesic increase or analgesic reduction ≥ 25% from baseline without an increase in pain;
  3. Pain progression: an increase in NRS ≥ 2 points above baseline with stable OMED or an increase ≥ 25% in OMED from baseline with NRS stable or 1 point above baseline;
  4. Indeterminate response: any response not captured by definitions 1, 2 and 3
one month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory (BPI)
Time Frame: 12 months
Brief Pain Inventory (BPI) will be used to capture patient estimates of their global rating of change in pain at the treatment site to anchor change scores on a given instrument. Clinically significant responses were defined as a reduction ≥ 2 from baseline
12 months
Quality of Life Questionnaire Cancer 15 Palliative Care (QLQ-C15-PAL)
Time Frame: 12 months
QLQ-C15-PAL will be used to capture patient estimates of their global rating of change in pain at the treatment site to anchor change scores on a given instrument. Clinically significant responses were defined as a reduction ≥5 points from baseline
12 months
Quality of Life Questionnaire Bone Metastases 22 (QLQ-BM22)
Time Frame: 12 months
QLQ-C15-PAL will be used to capture patient estimates of their global rating of change in pain at the treatment site to anchor change scores on a given instrument. Clinically significant responses were defined as a reduction ≥8 points from baseline
12 months
Compare incidence and severity of adverse events associated with the ExAblate MRgFUS bone system to that of EBRT.
Time Frame: 12 months
Safety of both treatments will be determined by an evaluation of the incidence and severity of device and procedure related complications from the first / treatment day visit through the 12-Months post-treatment time point. Adverse events were categorized according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

January 11, 2018

First Submitted That Met QC Criteria

January 18, 2018

First Posted (Actual)

January 19, 2018

Study Record Updates

Last Update Posted (Actual)

February 17, 2022

Last Update Submitted That Met QC Criteria

February 1, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BM-Fus Vs RT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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