July 30, 2007 - Visualase Inc., with its research partner BioTex Inc. and the Assistance Publique - Hopitaux de Paris healthcare network, have enrolled and completed treatment of the first six patients in a pilot, phase I study, with the objective to demonstrate the safety of the Visualase magnetic resonance (MR) guided laser thermal ablation technique for the minimally invasive treatment of brain metastasis.
An independent review after the first three treatments as required by the study protocol found that the technique was safe and that the trial should be allowed to progress to the next level in which larger tumors from additional sources could be included. The results obtained from the first six treatments demonstrate that the technique is feasible and safe for all procedures performed. Follow up of the patients over a period of up to six months also demonstrates a total or partial ablation of the treated metastasis.
The treatment is performed under local anaesthesia using an MR compatible stereotactic frame and planning software to accurately place a 1.6-millimeter diameter fiber optic laser applicator centrally inside the target tumor. The applicator delivers laser energy from a 15-Watt 980 nm diode laser through a diffusing tip to heat the tumor tissue. During treatment, the patient is positioned in a 1.5 Tesla magnetic resonance Imaging system while images are acquired continuously. The Visualase computer workstation processes the MR images to provide real time temperature maps and estimates of thermal damage around the applicator. The real-time damage predictions and safety points allow the treatment to be performed with a high degree of safety and precision. Typical laser delivery lasts less than five minutes, and after treatment is complete, patients immediately undergo additional MR Imaging, which allows post-treatment confirmation of the thermal ablation zone.
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