ENABLE (Exportable Notation and Bookmark List Engine): an Interface to Manage Tumor Measurement Data from PACS to...

Area of Science:

• Oncology
• Medical Imaging Informatics
• Clinical Trial Data Management

Background:

• Oncologists rely on tumor quantification via Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 for cancer trial therapeutic response evaluation.
• Current manual handwriting and data transfer of tumor measurements lead to inefficiencies and potential transcription errors.
• Picture Archiving Communication System (PACS) offers digital export of tumor measurements, enabling data management solutions.

Purpose of the Study:

• To develop and validate an automated system for managing tumor measurements and associated metadata from PACS.
• To eliminate manual data transcription in RECIST v1.1 assessments, thereby improving accuracy and efficiency.
• To create a digital workflow for cancer trial data compatible with existing databases.

Main Methods:

• Development of the Exportable Notation and Bookmark List Engine (ENABLE) interface.
• ENABLE interfaces with PACS to export tumor measurements and generate prepopulated RECIST v1.1 worksheets.
• Validation of ENABLE by comparing its output with existing RECIST v1.1 data from 8 patients (16 CT exams) and assessing usability with 7 staff members.
• Application of ENABLE to 42 metastatic genitourinary cancer patients to generate a best response waterfall plot.

Main Results:

• ENABLE successfully produced prepopulated RECIST v1.1 worksheets and compiled cohort data from PACS measurements.
• All 194 data points across 10 fields from ENABLE output precisely matched existing data.
• Seven staff members successfully used ENABLE after a 5-minute instructional video without further assistance.
• ENABLE facilitated the creation of a best response waterfall plot for 42 patients.

Conclusions:

• ENABLE effectively automates tumor measurement data management from PACS, eliminating manual transcription.
• The system enhances efficiency, reduces transcription errors, and improves the auditing process in cancer clinical trials.
• ENABLE provides a digital solution for managing tumor metadata, producing forms and data models compatible with cancer databases.