Radiomics Tool for Pulmonary Nodule Risk Stratification

Recruiting
99 years and younger
All
Phase N/A
300 participants needed
1 Location

Brief description of study

The objective of this pragmatic clinical trial is to determine the real-world effect of a radiomics-based computer-aided diagnosis tool on pulmonary nodule management decisions. We hypothesize that a higher proportion of pulmonary nodules will be appropriately managed when clinicians prospectively use a CAD-based risk stratification strategy to evaluate pulmonary nodules. The primary outcome variable is appropriate pulmonary nodule management at the index clinic visit, defined as the composite proportion of benign pulmonary nodules managed with surveillance and malignant pulmonary nodules managed with biopsy or empiric treatment. Final pulmonary nodule diagnosis will be categorized as malignant or benign. If the pathology report does not offer a specific pathologic diagnosis or is inconclusive (i.e., the biopsy was non-diagnostic), we will define pulmonary nodule resolution, shrinkage, or diameter stability at 12 months as a benign diagnosis. Secondary outcome variables will include measures of quality (timeliness), harms (adverse events), diagnostic yield, and healthcare costs.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Medical Research
  • Age: - 99 Years
  • Gender: All

TBD

Updated on 01 Aug 2024. Study ID: 853804

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