![]() 2, 3 The new criteria were designed as a uniform, simplified, and conservative standard to determine response to therapy for solid tumors. Imaging response guidelines called RECIST were published in 2000 to replace the 1981 World Health Organization (WHO) guidelines. Neuroradiologists should have a firm understanding of the issues involved in imaging brain tumors in clinical trials, not only with respect to review of quantitative imaging but also to assist in the optimal use of imaging in trial design. Radiographic response for each patient is then assigned according to predetermined criteria. 1 Phase II studies are usually conducted in patients with progressive tumors, and serial imaging examinations are performed after initiation of treatment and compared with a baseline pretreatment study. ![]() Imaging is crucial in phase II studies, however, because radiographic response, in combination with clinical status, is used to assess therapeutic effect. Phase I and phase III studies, with their respective goals of defining maximal tolerated dose and overall survival, do not rely on neuroimaging as a primary end point. This review will examine measurement approaches, response criteria, selection of lesions for measurement, technical imaging considerations, interval between tumor measurements and response confirmation, and validity of imaging as a measure of efficacy.Įnormous effort has been invested in clinical trials for malignant gliomas and brain metastases during the past 30 years. ![]() SUMMARY: There are substantial challenges in the radiologic evaluation of tumor size during clinical trials, and it is important for neuroradiologists to have a firm understanding of these issues. ![]()
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