Shafirstein Lab Clinical Trials

Advanced Image-Based Treatment Planning 

A first-in-human clinical trial demonstrated that image-guided interstitial photodynamic therapy (I-PDT) of refractory extrabronchial malignant central airway obstruction is safe and potentially effective. 

The image below, published in JTO Clinical and Research Reports, shows the Shafirstein Lab’s treatment plan for I-PDT of inoperable non–small cell lung cancer (NSCLC) with an airway obstruction. 

• A – A CT scan with outlines of the tumor and pulmonary artery.
• B – Digital mesh demarcating the tumor (red), pulmonary artery (purple) and airway (green).
• C – Cross section of the irradiance distribution from the light diffuser fibers. Range of irradiance, 0.4–955 mW/cm²
• D – Treatment plan for placement of fiber 4. Fiber 4 was placed 2.0 cm from the base of the carina and inserted into the tumor at a 30° angle off the base of the carina and at a depth of 1.7 cm into the target tumor tissue. Fiber 4 was placed at the 5 o’clock position in relation to 12 o’clock as being directly anterior.

This clinical trial is now in Phase II, supported by a National Cancer Institute award through collaboration with Simphotek, Inc. 

The integrating image-guided dosimetry also is being used to research “Interstitial Chemophototherapy with Light-Activated Nanoparticulate Doxorubicin” of large hepatocellular carcinoma in collaboration with PoP Biotechnologies, Inc., supported through awards from the NIH/NCI Small Business Technology Transfer (STTR) seed fund. 

Full text articlePhase 2 clinical trial