This Article Full Text Full Text (PDF) eLetters: Submit a response to this article Purchase Article View Shopping Cart Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Citation Map Services E-mail this article link to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Reprints/Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Jaffe, C. C. Search for Related Content PubMed PubMed Citation Articles by Jaffe, C. C.

Response Assessment in Clinical Trials: Implications for Sarcoma Clinical Trial Design

Diagnostic Imaging Branch, Cancer Imaging Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA

Key Words. RECIST • Response assessment • Clinical trial design • Imaging response

Correspondence: C. Carl Jaffe, M.D., National Cancer Institute, 6116 Executive Boulevard, Bethesda, Maryland 20892, USA. Telephone: 301-496-9531; Fax: 301-480-4631; e-mail: jaffec1{at}mail.nih.gov

Disclosure: No potential conflicts of interest were reported by the author, planners, reviewers, or staff managers of this article.

Response assessment and design of clinical trials require careful consideration of many factors, especially as validated response criteria can ultimately lead to the approval of an anticancer agent. Current anatomic imaging criteria are difficult to apply for evaluation of certain types of tumors, including soft tissue sarcomas. The emergence of new molecular imaging techniques, such as 64-slice computed tomography scanners and dynamic contrast magnetic resonance imaging, provide complementary information to conventional anatomical imaging. Currently the U.S. National Cancer Institute and the U.S. Food and Drug Administration are aiming to revise existing response criteria based on the development of volumetric anatomic imaging for oncology. Reviewing existing and new approaches in the design of clinical trials will help to optimize the clinical development and evaluation of new therapies for sarcomas.

This article has been cited by other articles:

				R. S. Benjamin SARC-CTOS Imaging Symposium: Introduction to the Problem from a Clinical Perspective Oncologist, April 1, 2008; 13(suppl_2): 1 - 3. [Abstract] [Full Text] [PDF]

				A. D. Van den Abbeele The Lessons of GIST--PET and PET/CT: A New Paradigm for Imaging Oncologist, April 1, 2008; 13(suppl_2): 8 - 13. [Abstract] [Full Text] [PDF]