Phase II year
2021
(last award dollars: 2022)
Phase II Amount
$2,050,000
To establish the efficacy of interstitial photodynamic therapy (I-PDT) for solid cancer treatments, thetreating physician needs to be able to tailor the treatments to each patient. During I-PDT in the clinic, there is aneed to adjust the irradiance (light dose rate) and fluence (light dose) to account for patient-specific tissue andtumor optical properties and to account for changes in fiber placements that occur after an initial pretreatmentplan is generated. This can be accomplished with the novel, near real-time computational software, DOSIETM,developed by Simphotek, Inc. The DOSIE key advantages are: (i) it is a dedicated single-package softwarepackage for computing dose metrics of intratumoral light irradiance and fluence for I-PDT; and (ii) it includes afast algorithm for updating the laser light settings according to optical properties of the tumor and actual fiberplacement in near real-time. To demonstrate that DOSIE can effectively guide I-PDT, Simphotek and RP proposeto conduct a pilot Phase II clinical study (Phase IIa) on patients with solid malignancies in the lung causing centralairway obstruction involving extrinsic tumor growth and related airway compression. The proposed trial will utilizeendobronchial ultrasound (EBUS) with a transbronchial needle (TBN) that will be used to guide optical diffuserfiber insertion for intratumoral illumination in I-PDT. The DOSIE treatment planning system that will be employedin this trial is vital to calculate the intratumoral fluence and irradiance, which will impact tumor response in I-PDTof the locally advanced cancers.
Public Health Relevance Statement: The general lack of effective treatment planning tools that can provide patients with
individualized cancer treatments is a critical barrier to continued progress in interstitial
photodynamic therapy (I-PDT). Simphotek, Inc. proposes to fill this unmet need by developing
unique prototype software and hardware tools that can be easily utilized by I-PDT physicians in
the clinic. Effective I-PDT treatment planning is expected to improve patient outcomes, reduce
the occurrence of under- and over-exposure treatments and therefore reduce overall costs in
cancer-related therapy.
Project Terms:
