Michael.soulen@uphs.upenn.edu

1) Identify the gaps in necessary knowledge of oncology present in existing radiology training schemes and opportunities to close these gaps. 2) Identify the expected standards for clinical research in oncology and what interventional oncologists need to do to meet them. 3) Outline unique challenges in clinical trial design in IO and strategies to overcome them.

ahmed.gabr@northwestern.edu

To report outcomes of radioembolization (TARE) of hepatocellular carcinoma (HCC) patients successfully downstaged to liver transplantation (LT) despite presenting with tumor stage beyond Milan Transplant Criteria.

With IRB approval, we conducted a retrospective chart review (2005-2018) for HCC patients who presented with tumors beyond Milan criteria and were successfully downstaged to LT with TARE. Baseline (pre-TARE) and imaging immediately prior to LT were assessed to confirm and compare UNOS tumor stage. All explants underwent histopathologic assessment to evaluate degree of tumor necrosis and presence of vascular invasion (PVT). Overall survival (OS) and recurrence free survival (RFS) rates were estimated using Kaplan-Meier method.

38 (30 males; mean age 60 years) patients underwent LT after TARE as a downstaging therapy. Prior to TARE, 22 (58%) patients had T3 tumors, 12 (32%) had T4a tumors and 4 (10%) had T4b tumors with PVT. Patients were listed for LT after achieving good response to TARE at a median of 3.8 (CI: 2-6) months. 29 (76%) patients received cadaveric organs while 9 (24%) received living donor organs. At time of LT, 18 (47%) were downstaged to T2 (14 from T3, 2 from T4a, 2 from T4b). 20 (53%) patients did not achieve downstaging by size, but they achieved necrosis (mRECIST) response allowing LT. 16 (42%) displayed complete tumor necrosis at explant, 15 (39%) and 7 (18%) had extensive (>50%) and partial (<50%) necrosis, respectively. Median OS of entire cohort was 12.5 (CI: 4.6-12.5) years from LT. There was no difference in OS between patients who were downstaged by size to T2 vs patients who were >T2 at LT (p = 0.8). Median RFS was 6.5 (3.1-12.5) years, not significantly different for T2 vs >T2 tumors at LT.

TARE is effective in downstaging HCC patients beyond Milan Criteria, facilitating long-term survival outcomes following LT in these patients. This is evident not only in patients with T3 tumors but also for those with T4a and T4b disease. The results are consistent for both those downstaged based on size and necrosis criteria.

Outcomes of Liver transplantation of HCC patients beyond Milan Criteria are satisfactory provided that they underwent downstaging treatment with Y90 radioembolization which can be achieved by inducing mRECIST response and tumor necrosis.

j.blume@vanderbilt.edu

1) To explain the role of p-values and their proper usage. 2) To understand why confidence intervals are essential for proper interpretation of results. 3) To introduce modern assessment tools, such as second-generation p-values and false discovery rates.

In March of 2016, the American Statistical Association (ASA) released a statement on statistical significance and p-values. The statement detailed a vision for a reduced role of p-values in science, with greater emphasis on estimation, confidence intervals, and alternative assessments that account for clinical significance. In this talk, I will review the origins of p-value based inference and discuss the main thrust of the ASA's statement. I will also introduce more modern tools (second-generation p-values, false discovery rates, interval estimation) that provide a more nuanced statistical assessment, which is often more appropriate for science.

mmendira@med.umich.edu

1) Become familiar with the various types of locoregional therapy, using hepatocellular carcinoma as a prototype. 2) Evaluate imaging post-locoregional therapy to assess treatment response. 3) Identify imaging challenges when assessing tumor response after various forms of locoregional therapy. 4) Become familiar with existing tumor response criteria, such as mRECIST, EASL and LIRADS while also understanding pitfalls in treatment response assessment based on the type of locoregional treatment.

martinc7@ccf.org

To describe our use of true 3D holographic guidance for PTA (3D HPA) in our first five first-in-human clinical evaluations, leading to increased ablation accuracy and usability of this technilogy.

3D Holograms of the ablation probe and the liver and its target tumors, based on fused CT and real-time ultrasound images, are created using Unity software and then superimposed directly onto the operative site for more accurate probe placement relative to the preoperative plan. More accurate delivery of heat to target tumors with less to adjacent healthy tissue will yield fewer post-procedure complications and is key for treating tumors (<3 cm diameter) and complex anatomy. The resulting accuracy and usability provided by real-time, fused holographic visualization is of growing significance, as the use of PTA is increasing.

We demonstrate in our first five cases that that this novel technique can be used to accurately target liver tumors and effectively ablate the lesions of concern in the liver.

New augmented reality (AR) headsets such as HoloLens have potential to benefit percutaneous intervention by overcoming limitations of 2D monitors presently used in standard-of-care image-guidance. Through these first five procedures our plan is to demonstrate the benefits of the unique platform relative to the use of 2D-monitors alone including improved tumor targeting (3), lower x-ray radiation dose (4), decreased procedure time (2), and improved overall outcomes for tumor ablation and a broad range of minimally invasive applications.

This technique improves the safety and effectiveness of tumor ablation, and possibly other percutaneous procedures, by enhancing spatial and depth perception in comparison with 2D displays.

1) Define what constitutes patient reported outcomes. 2) Describe the main types of patient reported outcome instruments. 3) Understand why patient reported outcomes are important in interventional oncology.