Over 40,000 patients in 34 countries (excluding the U.S.)

have been treated with Gleolan® with favorable results.

 
 

FLUORESCENT GUIDED IMAGING

Being able to visualize the tumor with a high degree of sensitivity and specificity is the key attribute of using Gleolan®. Numerous published reports have described a greater degree of tumor removal in patients treated with Gleolan® than under standard conditions with room light. Phase III studies in Europe confirmed that complete resection is achieved in 37.6% of the patients under standard of care and increases to 63.6% using Gleolan® to enhance visualization (Stummer et al. 2010).

Many researchers have demonstrated that the extent of resection of a brain tumor is highly correlated to survival. Lacroix et al (2001) concluded that the removal of 98% or more of the tumor has been associated with a significantly longer survival time than if less than 98% of the tumor is removed. Despite numerous publications suggesting that Fluorescence-Guided imaging during surgery improves patient survival this assumption remains controversial and unproven. 

Despite this controversy it is a universally accepted premise that maximizing tumor removal is in the best interest of brain tumor patients. The difficulty is in the visualization of the resected margin and knowing where the tumor margins end and healthy tissue resides, Fluorescence-guided imaging during surgery has become a marketed surgical adjunct in 34 countries outside North America for enhancing the real time visualization allowing surgeons to see what is malignant versus normal brain tissue. The goal of NXDC is to support neurosurgeons by providing a convenient tool for real time visualization of brain tumors that may increase the precision and extent of tumor resection.

THE USE OF GLeOLAN®

Upon conducting research with leaders in the field it is clear that a key factor in the upfront management of GBM is the ability to achieve a gross total tumor resection. Phase III studies in Europe confirmed that complete resection is achieved in 37.6% of the patients under standard of care and increases to 63.6% using Gleolan® to enhance visualization (Stummer et al. 2010).

Numerous reports have supported the claim of optimizing resection with Gleolan®. Thus, an ideal solution for neurosurgeons is providing a convenient tool for real time visualization of brain tumors that may increase the precision and extent of tumor resection.

The use of Gleolan® in conjunction with fluorescence add-on kits manufactured by the two leading surgical microscope manufacturers provides just such a solution.