Patient tailored near real-time image-based treatment for interstitial PDT of Inoperable Cancer with Airway Obstruction - Phase IIa

Information

  • Research Project
  • 10325471
  • ApplicationId
    10325471
  • Core Project Number
    R44CA265656
  • Full Project Number
    1R44CA265656-01
  • Serial Number
    265656
  • FOA Number
    PA-20-262
  • Sub Project Id
  • Project Start Date
    8/11/2021 - 4 years ago
  • Project End Date
    7/31/2023 - 2 years ago
  • Program Officer Name
    NARAYANAN, DEEPA
  • Budget Start Date
    8/11/2021 - 4 years ago
  • Budget End Date
    7/31/2022 - 3 years ago
  • Fiscal Year
    2021
  • Support Year
    01
  • Suffix
  • Award Notice Date
    8/11/2021 - 4 years ago
Organizations

Patient tailored near real-time image-based treatment for interstitial PDT of Inoperable Cancer with Airway Obstruction - Phase IIa

Abstract To establish the efficacy of interstitial photodynamic therapy (I-PDT) for solid cancer treatments, the treating physician needs to be able to tailor the treatments to each patient. During I-PDT in the clinic, there is a need to adjust the irradiance (light dose rate) and fluence (light dose) to account for patient-specific tissue and tumor optical properties and to account for changes in fiber placements that occur after an initial pretreatment plan 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 software package for computing dose metrics of intratumoral light irradiance and fluence for I-PDT; and (ii) it includes a fast algorithm for updating the laser light settings according to optical properties of the tumor and actual fiber placement in near real-time. To demonstrate that DOSIE can effectively guide I-PDT, Simphotek and RP propose to conduct a pilot Phase II clinical study (Phase IIa) on patients with solid malignancies in the lung causing central airway obstruction involving extrinsic tumor growth and related airway compression. The proposed trial will utilize endobronchial ultrasound (EBUS) with a transbronchial needle (TBN) that will be used to guide optical diffuser fiber insertion for intratumoral illumination in I-PDT. The DOSIE treatment planning system that will be employed in this trial is vital to calculate the intratumoral fluence and irradiance, which will impact tumor response in I-PDT of the locally advanced cancers.

IC Name
NATIONAL CANCER INSTITUTE
  • Activity
    R44
  • Administering IC
    CA
  • Application Type
    1
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    1050000
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    395
  • Ed Inst. Type
  • Funding ICs
    NCI:1050000\
  • Funding Mechanism
    SBIR-STTR RPGs
  • Study Section
    ZRG1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    SIMPHOTEK, INC.
  • Organization Department
  • Organization DUNS
    800606860
  • Organization City
    NEWARK
  • Organization State
    NJ
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    071033568
  • Organization District
    UNITED STATES