An interventional study of Bone Metastases Pain treatment in Secondary Bone Cancer and Bone Metastases, sponsored by University of Roma La Sapienza. Completed at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-17.
Sponsored by University of Roma La Sapienza · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Patients with unstable cardiac status including:
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
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)
Determine the effect of MRgFUS in terms of level of pain relief and decrease in analgesics/opiate and improved quality of life.
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
Time frame: one month
Brief Pain Inventory (BPI)
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
Time frame: 12 months
Quality of Life Questionnaire Cancer 15 Palliative Care (QLQ-C15-PAL)
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
Time frame: 12 months
Quality of Life Questionnaire Bone Metastases 22 (QLQ-BM22)
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
Time frame: 12 months
Compare incidence and severity of adverse events associated with the ExAblate MRgFUS bone system to that of EBRT.
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
Time frame: 12 months
Plan to share: Undecided
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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University of Roma La Sapienza