Cavernous Angioma Symptomatic Hemorrhage (CASH) Trial Readiness II: Imaging Biomarkers and Trial Modeling.
Stephanie HageSerena KinkadeRomuald GirardKelly D FlemmingHelen KimMichel T TorbeyJudy HuangJohn HustonYunhong ShuReed G SelwynBlaine L HartMarc C MabrayJames FeghaliHaris I SairJared NarvidJanine M LupoJustine LeeAgnieszka StadnikRoberto J Alcazar-FelixRobert ShenkarNicholas HobsonDorothy DeBiasseKaren LaneNichole McBeeKevin TreineNoeleen OstapkovichYing WangRichard E ThompsonM Carolina Mendoza-PucciniJaroslaw AronowskiTimothy J CarrollDaniel F HanleyIssam A AwadPublished in: medRxiv : the preprint server for health sciences (2023)
Assessment of QSM change is feasible and sensitive to recurrent bleeding in CASH. Evaluation of an intervention on QSM percent change may be used as a time-averaged difference between 2 arms using a repeated measures analysis. DCEQP change is associated with lesser sensitivity and higher variability than QSM. These results are the basis of an application for certification by the U.S. F.D.A. of QSM as a biomarker of drug effect in CASH.