Phase III trial of experimental therapy for bone pain
Posted Sep 28 2008 1:49pm
According to a special issue of the US TOO e-newsletter News You Can Use, the InSightec company has initiated an FDA-approved, phase III pivotal study to evaluate the effectiveness and safety of their magnetic resonance-guided, focused ultrasound (MRgFUS) technology, known as ExAblate®, for the palliation of pain from metastatic bone tumors in patients who are inappropriate candidates for radiation therapy.
ExAblate MRgFUS technology applies focused ultrasound, through a non-invasive procedure, to treat metastatic bone and associated tissue without the need for surgery. The application of the ExAblate system for the palliation of pain from bone metastases in patients with cancer is experimental. The study hypothesis is that ExAblate is safe and effective in the treatment of pain resulting from metastatic bone tumors in patients that did not respond to radiation treatment or who are otherwise unsuitable for radiation treatment, with a low incidence of co-morbidity.
This clinical trial is currently open for patient enrollment at four US study sites as well as a site in Israel (where InSightec has its headquarters). For a study summary and a list of participating sites, please see the study summary on the ClinicalTrials.gov web site.
InSightec’s ExAblate technology has previously been approved for the treatment of uterine fibroids. According to the current study summary, this trial will include men and women with any form of bone metastasis, but late-stage patients with prostate cancer, breast cancer, and lung cancer are at particularly high risk for this type of metastasis.
According to a special issue of the US TOO e-newsletter News You Can Use, the InSightec company has initiated an FDA-approved, phase III pivotal study to evaluate the effectiveness and safety of their magnetic resonance-guided, focused ultrasound (MRgFUS) technology, known as ExAblate®, for the palliation of pain from metastatic bone tumors in patients who are inappropriate candidates for radiation therapy.
ExAblate MRgFUS technology applies focused ultrasound, through a non-invasive procedure, to treat metastatic bone and associated tissue without the need for surgery. The application of the ExAblate system for the palliation of pain from bone metastases in patients with cancer is experimental. The study hypothesis is that ExAblate is safe and effective in the treatment of pain resulting from metastatic bone tumors in patients that did not respond to radiation treatment or who are otherwise unsuitable for radiation treatment, with a low incidence of co-morbidity.
This clinical trial is currently open for patient enrollment at four US study sites as well as a site in Israel (where InSightec has its headquarters). For a study summary and a list of participating sites, please see the study summary on the ClinicalTrials.gov web site.
InSightec’s ExAblate technology has previously been approved for the treatment of uterine fibroids. According to the current study summary, this trial will include men and women with any form of bone metastasis, but late-stage patients with prostate cancer, breast cancer, and lung cancer are at particularly high risk for this type of metastasis.
Filed under: Management, Treatment