Imaging is an essential component in numerous research projects, and specifically in oncologic trials with solid tumors. The primary end point for many oncologic trials is imaging-based and commonly includes progression-free survival, time to progression, or best overall response. There are major challenges in implementing imaging in multi-institutional trials that need to be overcome to maintain high accuracy, reduce errors, and improve standardization. In addition, human imaging research is broad based and crosses many clinical specialties, including radiology, pathology, cardiology, oncology, neurology, neurosurgery, surgery, ENT, ophthalmology, dermatology, and more.

The HISF enhances imaging-related research activities and clinical trials with imaging endpoints across campus through standardization of imaging research protocols, coordination of non-routine imaging services, and development and validation of imaging biomarker and artificial intelligence (AI) algorithms. The HISF coordinates CT, MRI, PET CT, PET MRI, X-rays, mammography, ultrasound, fluoroscopy and/or image-guided biopsies or procedures that are utilized in oncologic clinical trials. The study protocols of all oncologic clinical trials with human imaging are reviewed, and the HISF provides quality assurance that all clinical trial participants get the precise image acquisition protocol needed to meet the standards of each clinical trial. This improves patient outcomes and standardizes data collection to maximize the potential of each clinical trial.                                                                     

For all clinical trial patients with solid tumors that have imaging end points, the HISF coordinates longitudinal tumor response assessments that adhere to the specific tumor response criteria in each trial (e.g. RECIST 1.1, iRECIST, Lugano, RANO, etc.). Imaging trial management and adherence to the specific tumor response criteria for each patient and trial has been challenging using traditional tracking methods. In response to this challenge, the HISF built the world’s first augmented intelligence imaging trial management system and image viewer (AI Metrics v1.0). AI Metrics is FDA cleared, 21 CFR Part 11 compliant, and leverages AI and guided workflows that improve patient care and research data by digitizing all tumor imaging and tumor response data, reducing human errors, and improving accuracy and inter-observer agreement. The AI Metrics platform annotates all tumor findings and utilizes a radiomics tools that allow for development and validation of new imaging biomarkers and new AI algorithms. In addition, the HISF is in the process of building a research management system to track clinical trials and new imaging research and annotation projects.