MR Guided Focused Ultrasound Surgery in the Treatment of Pain From Bone Tumors w/ the ExAblate 2000 Strappable System — BM005  

Bone Metastases Clinical Trial

Official title: MR Guided Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2000 Strappable System

Status Completed

Clinical Trial Summary

A Feasibility Study To Evaluate the Safety and initial Effectiveness of MR guided Focused Ultrasound Surgery in the Treatment of pain resulting from Metastatic Bone Tumors with the ExAblate 2000 strappable system.

Clinical Trial Description

Bone is the third most common organ involved by metastatic disease behind lung and liver. In breast cancer, bone is the second most common site of metastatic spread, and 90% of patients dying of breast cancer have bone metastasis. Breast and prostate cancer metastasize to bone most frequently, which reflects the high incidence of both of these tumors, as well as their prolonged clinical courses.

Post cancer survival has increased with improvement in early detection and treatments. As a consequence, the number of patients developing metastatic bone disease during their lifetime has also increased. Patients with bone metastasis from breast cancer have an average 2-year survival from the time of presentation with their first bone lesion. In patients who die from breast, prostate, and lung cancer, autopsy studies have shown that up to 85% have evidence of bone metastases at the time of death.

Current treatments for patients with bone metastases are primarily palliative and include localized therapies (radiation and surgery), systemic therapies (chemotherapy, hormonal therapy, radiopharmaceutical, and bisphosphonates), and analgesics (opioids and non-steroidal anti-inflammatory drugs). Recently, radiofrequency ablation has been tested as a treatment option for bone metastases. The main goals of these treatments are improvement of quality of life and functional level. These goals can be further described: 1) Pain relief, 2) Preservation and restoration of function, 3) Local tumor control, 4) Skeletal stabilization.

The study hypothesis is that treatment with the MRgFUS, which is delivered by a strappable transducer, is a safe and potentially effective non-invasive treatment for metastatic bone tumors with a low incidence of co-morbidity. Based on the results of this study the Sponsor will initiate a larger study in an attempt to obtain regulatory approval for the treatment of metastatic bone tumors as an indication for the MRgFUS ExAblate strappable system. ;

Related Conditions & MeSH terms

• Bone Metastases
• Bone Neoplasms

• NCT number: NCT03547557
• Study type: Interventional
• Source: InSightec
• Status: Completed
• Phase: N/A
• Start date: January 2007
• Completion date: March 2009