Investigator: Robert Jeraj, Martina Vrankar, Damijan Valentinuzzi, et al.

The overall goal of this research is to determine whether “immunotherapy FDG PET/CT signature (irRADIOMICS)” based on radiomics assessment of FDG PET/CT data can predict response to immunotherapy. This research has 3 specific aims:

• SPECIFIC AIM 1: To assess the dynamics of “immunotherapy FDG PET/CT signature (irRADIOMICS)”. The dynamics of immunotherapy FDG PET/CT signature (irRADIOMICS) will be assessed by longitudinal follow-up of selected imaging features through the course of immunotherapy, without and in combination with other therapies (e.g., radiotherapy). Significant radiomics imaging features, based on our pilot analysis and including those reported in the literature will be followed through time.

• SPECIFIC AIM 2: To determine variability of irRADIOMICS in patients with multiple lesions. Variability of irRADIOMICS assessment will be determined by comparing differences in irRADIOMICS signatures between various metastatic lesions in the same patient. In patients receiving a follow-up radiation therapy to symptomatic lesions (common treatment for these patients) differences in irRADIOMICS signatures between irradiated and non-irradiated lesions will be compared.

• SPECIFIC AIM 3: To evaluate whether irRADIOMICS predicts response to immunotherapy better than irRC. Correlation of irRADIOMICS and irRC assessment to progression-free survival (PFS) and overall survival (OS) will be compared. Predictive power of both indices for long-term response on individual level will be assessed.

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