New trial will assess MR-HIFU, chemo drug combo

The Children's National Health System in Washington, DC, and oncology drug development firm Celsion have launched a clinical study to evaluate MR-guided high-intensity focused ultrasound (MR-HIFU) and a heat-activated chemotherapy drug for treating refractory or relapsed solid tumors in children and young adults.

The phase I study is partially funded by a grant from the U.S. National Institutes of Health (NIH), and its primary objective is to determine a safe and tolerable dose of Celsion's ThermoDox drug -- a lyso-thermosensitive liposomal doxorubicin (LTLD) that can be administered in combination with MR-HIFU. Under MRI guidance, the HIFU system will heat the tumor and the area around the tumor. When heated, the liposome changes structure and releases doxorubicin directly into and around the targeted tumor, according to Children's National and Celsion.

The study targeting the treatment of childhood sarcomas will be a multidisciplinary collaboration between Children's National, Celsion, and Dr. Bradford Wood's team at the NIH. It is the first time that LTLD is being combined with MR-HIFU, and it's also the first time it's being evaluated in children, according to the organizations.

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