Imaging process boosts efficiency in oncology device trial

A prominent medical device company was conducting a feasibility study for a device to improve accurate identification of peripheral pulmonary nodules in high risk adult patients. If developed, the device could improve accurate identification of malignancy and increase diagnostic capabilities. The study required a sample of 50 participants across five sites over two and a half years. Using improved image resolution and video would increase diagnosis accuracy of malignant nodules in high risk patients’ lungs.

Quality imaging data from multiple sources was critical to the study’s success. At least three sources of imaging data were acquired for every participant, sometimes including video. After site activation, ICON Imaging were asked to help manage multiple sources of imaging data for each participant. The sponsor’s electronic data collection (EDC) system and imaging system were not integrated and lacked a quality check process to correlate participant data with imaging data. This led to errors in reconciling images between multiple data sources. ICON and the sponsor teams carried out an interim analysis, identifying several discrepancies in imaging data.

A cross-functional team from ICON’s Imaging, Clinical Operations and Data Management collaborated to develop a new imaging reconciliation process. This corrected previous errors and captured participant data to demonstrate the medical device’s efficacy. The Imaging team created a reconciliation plan and process and shared these with their team, clinical research associates (CRAs) and data management (DM) colleagues.

Close collaboration between ICON’s Imaging, Clinical Operations and Data Management teams reconciled all imaging sources with the corresponding participant data in the EDC. Crucially this was achieved in under 4 weeks, allowing the Database Lock to be complete a month ahead of schedule and resulting in study completion under budget.