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Risk Profile Assessment to Aid in Patient Selection Criteria for a Novel Lung Tissue Excision Tool in Lung Cancer Diagnosis and Intervention

Principal Investigator
Name
Lance Black
Degrees
M.D.
Institution
Prana Thoracic
Position Title
Chief Clinical Strategy Officer
Email
About this CDAS Project
Study
NLST (Learn more about this study)
Project ID
NLST-1142
Initial CDAS Request Approval
Oct 19, 2023
Title
Risk Profile Assessment to Aid in Patient Selection Criteria for a Novel Lung Tissue Excision Tool in Lung Cancer Diagnosis and Intervention
Summary
The National Lung Screening Trial effectively demonstrated that lung cancer screening with low-dose CT reduces mortality from lung cancer. In addition, it highlighted the large number of people within the U.S. who are eligible for this type of screening resulting in a number of updated recommendations including those established by the USPSTF. With a growing population of eligible patients, addressing potential obstacles in the screening and early intervention processes will become increasingly crucial. Prana Thoracic is developing a novel lung tissue excision tool to aid in diagnosis and early intervention in lung cancer thereby allowing for higher quality accommodation of this anticipated rise in patients expected to undergo lung cancer screening.

The intention of this project is to carry out a descriptive and epidemiologic analyses to gain a better understanding of risk profiles (based on known risk factors) and their subsequent outcomes. In subjects who are screened and confirmed to have lung cancer, we'd like to understand factors that would make them appropriate candidates for Prana Thoracic's lung tissue excision tool currently under development. These factors include, but are not limited to, the size, location, and morphology/CT characterization of the nodule; the proximal position of anatomical structures; and the patient's surgical risk level.

This analysis will play a pivotal role in determining the appropriate selection criteria for potential candidates, geographies, and institutions in the upcoming trials investigating the novel tissue excision technology.
Aims

1. Evaluation of Candidacy Criteria: To determine specific criteria and parameters, such as nodule size, location, and morphological features revealed through CT imaging, alongside considerations of anatomical proximity and surgical risk, that qualify individuals as suitable candidates for the implementation of the novel lung tissue excision tool.
2. Identification of Optimal Patient Selection Strategies: To develop effective strategies for the selection and identification of patients most likely to benefit from the utilization of the proposed lung tissue excision tool, considering a holistic approach that integrates risk profiles, clinical characteristics, geographic location, and imaging findings.
3. Validation of Feasibility and Efficacy in Targeted Population: To assess the feasibility and efficacy of the proposed patient selection criteria and risk profiles in predicting successful outcomes and improved intervention efficacy with the use of the novel lung tissue excision tool, thereby contributing to the refinement of the tool's clinical utility and the optimization of patient outcomes.

Collaborators

Joanna Nathan (CEO, Prana Thoracic)
Carolyne Lu (Director of ClinReg Strategy, Prana Thoracic)
Lance Black, MD (Chief Clinical Strategy Officer, Prana Thoracic)
Rick Fischel, MD (Thoracic Surgeon, CMO Prana Thoracic)
Ed Boyle, MD (Thoracic Surgeon, CSO Prana Thoracic, St. Charles Medical Center)
Billy Cohn, MD (Cardiothoracic Surgeon, Texas Heart Institute at Baylor St Luke's Medical Center)
Rich Miller, MD (Thoracic Surgeon, Penrose-St. Francis Health Services)