Galit Aviram MD, Presenter: Consultant, ActiViews Ltd

Yehuda Schwarz, Abstract Co-Author: Consultant, ActiViews Ltd

Avi Mann MD, Abstract Co-Author: Nothing to Disclose

Boaz Tiran, Abstract Co-Author: Nothing to Disclose

Galia Rosen Tirosh MD, Abstract Co-Author: Nothing to Disclose

Jacob Sosna MD, Abstract Co-Author: Consultant, ActiViews Ltd Advisory Board, CMT Medical Technologies Ltd Research grant, Koninklijke Philips Electronics NV

To prospectively evaluate the safety and accuracy of a stereotactic computer guidance optical needle tracking system for the performance of CT guided lung biopsies in human subjects.

The study was performed with IRB approval after obtaining all patients' informed consent. As this was the initial human study with the evaluated system inclusion criteria required a single target pulmonary lesion greater than 10mm in diameter, located in the lung within a depth greater than 40mm from the skin. Ten patients (7 males, 3 females), ages 35 - 86 (mean age 63) with lung lesions (mean diameter 41±15mm) suspicious for malignancy, underwent CT guided interventions using ActiSight Needle Guidance System (ActiViews Ltd. Haifa Israel), with 20 gauge Ciba needles. ActiSight Needle Guidance System is a novel optical navigation system which displays a real-time image on a computer monitor of a CT-based model of the target location, and the projected needle path to target. Using a label sticker attached to the surface of the body at the desired point of entry with eight x-ray absorbing fiducials, and a miniature disposable video camera mounted on the biopsy needle, a real time six degrees of freedom (3D location and angles) information on the needle relative to the target is provided to the operator for guidance during the procedure. Post-procedure CT was performed to assess system accuracy and complications. Accuracy of reaching the pre-selected points within the target lesions, procedure time, number of needle passes and rate of complications were recorded.

All lesions have been successfully reached with one needle pass. Adequate samples were obtained in all patients. Mean distance between the needle's tip and the pre-selected points within the lesions was only 1.6±1.1mm. Mean procedure time was 25±8 min. Two patients developed small post procedural pneumothoraces.

Our preliminary experience suggests that the use of this novel stereotactic computer guidance optical needle tracking system for the performance of CT guided lung biopsies is safe and accurate. Additional clinical trials are underway.

The use of a stereotactic guidance system may lead to improved success in biopsy of small lesions with reduction in the time, complications and radiation associated with this challenging procedure.

Aviram, G, Schwarz, Y, Mann, A, Tiran, B, Rosen Tirosh, G, Sosna, J, CT-guided Lung Biopsies Using a Novel Optical Navigation System: Initial Human Experience.  Radiological Society of North America 2009 Scientific Assembly and Annual Meeting, November 29 - December 4, 2009 ,Chicago IL. http://archive.rsna.org/2009/8003225.html