#RSNA deserves tremendous credit for putting on such a fabulous program. As an incubator for future clinical researchers, it is amazing to watch the action. While the student junior faculty work to assemble coherent protocols, they are surrounded by the top academic experts in the country (including many chairman and section chiefs), donating a week of their time and expertise. It is a once in a lifetime experience. In my small group, the outcomes researcher identified appropriate QOL instruments for each study and sent the source to the students, while the radiation oncologist pulled out standard templates for dose escalation to drop into their protocols and the statistician helped each student craft their stats design and sample size. After the small group sessions, students can sign up for one-on one faculty meetings; I met with most of the other IR attendees from outside my group.
My students have made great strides. With four faculty commenting on their protocol drafts daily, the documents are a sea of colors in “Track Changes”. We have worked through crafting a clearly worded hypothesis and translating it into primary and secondary objectives with defined endpoints. With their focus clear, they are now writing detailed Methods and Statistics sections.
Jason Iannuccilli has defined a randomized Phase 2 trial of selective pulmonary artery chemoembolization (SPACE) + MWA vs. MWA alone for local control of 2-5 cm unresectable lung cancers. One thing we learned was that to get a sample size adequately powered to measure his hoped-for effect, he needs to partner with a second high-volume center.
Alex Kim designed a standard Phase 1 3+3 dose escalation study for resin Y90 microspheres with doses delivered in 4 fractions instead of as a single bolus, starting at BSA +10%.
Derek West also settled on a Phase 1 3+3 dose escalation design for IRE in patients with locally advanced pancreatic cancer receiving concurrent gemcitabine, with escalation of the IRE field strength.
Hyeon Yu ended up with a single arm cohort study of MWA for local control of intermediate-size HCC.
All these studies have multiple secondary objectives and endpoints. I am looking forward to seeing how they evolve as we move into the nitty-gritty of their methods sections today.
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