RSNA’s intensive workshop on clinical trial design kicked off last night. Nine of the 29 “students” are interventional radiologists, up from only one last year. After the morning didactic sessions, we break up into five small working groups to intensively develop each student’s protocol proposal. My group has six of the nine IR’s, the others are distributed into other groups.
As I mentioned in my prior post (Nov. 11, 2013), the initial concepts the students submitted needed a lot of refining. Fortunately they responded well to pre-meeting feedback and came prepared for their first beat-down at last night’s session.
Jason Iannuccilli from Brown University proposes a randomized trial of microwave ablation with or without segmental pulmonary artery chemoembolization for local control of Stage I lung cancers between 3-5 cm. Alex Kim from Georgetown wants to examine dose fractionation of Y90 resin microspheres to see if response rates can be improved without sacrificing toxicity. Derek West from UT Houston is interested in combining IRE with systemic chemotherapy in pancreatic cancer, hypothesizing that increased drug effect will occur in the zone of reversible electroporation around the IRE zone. Hyeon Yu from UNC wants to study MWA versus RFA in the liver. Sarah White from MCW is evaluating the impact of early palliative care referral in HCC patients. Josh Dowell from OSU is asking if MR elastography can predict response to DEB-TACE. Other IR topics include left gastric embolization to decrease ghrelin levels in obese patients, and systemic versus catheter-directed lysis in sub-massive PE.
For all these great ideas, the devil is in the details. What is the important question to be answered (hypothesis)? How are you going to measure it (endpoints)? The fun thing about a group of IR’s is that no one is shy; the students chimed in on each other’s protocols with as much vigor as the faculty. The variation in practice among different centers is always eye-opening. (Really? You do that??) We got so raucous that groups in adjoining rooms complained they couldn’t hear themselves.
As the week goes on I’ll post updates on the students’ progress. Feel free to post comments yourself.