title: Quantitative Imaging in Cancer Clinical Trials.
abstract: As anticancer therapies designed to target specific molecular pathways have been developed, it has become critical to develop methods to assess the response induced by such agents. Although traditional, anatomic CT, and MRI examinations are useful in many settings, increasing evidence suggests that these methods cannot answer the fundamental biologic and physiologic questions essential for assessment and, eventually, prediction of treatment response in the clinical trial setting, especially in the critical period soon after treatment is initiated. To optimally apply advances in quantitative imaging methods to trials of targeted cancer therapy, new infrastructure improvements are needed that incorporate these emerging techniques into the settings where they are most likely to have impact. In this review, we first elucidate the needs for therapeutic response assessment in the era of molecularly targeted therapy and describe how quantitative imaging can most effectively provide scientifically and clinically relevant data. We then describe the tools and methods required to apply quantitative imaging and provide concrete examples of work making these advances practically available for routine application in clinical trials. We conclude by proposing strategies to surmount barriers to wider incorporation of these quantitative imaging methods into clinical trials and, eventually, clinical practice. Our goal is to encourage and guide the oncology community to deploy standardized quantitative imaging techniques in clinical trials to further personalize care for cancer patients and to provide a more efficient path for the development of improved targeted therapies.
authors.affiliation: Institute of Imaging Science, Departments of Radiology and Radiological Sciences, Biomedical Engineering, Physics, and Cancer Biology, Vanderbilt University, Nashville, Tennessee. thomas.yankeelov@utexas.edu.
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Yankeelov
authors.affiliation: Radiology/Nuclear Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: David A
authors.initials: DA
authors.lastname: Mankoff
authors.affiliation: Department of Radiology, Columbia University, New York, New York.
authors.forename: Lawrence H
authors.initials: LH
authors.lastname: Schwartz
authors.affiliation: Departments of Neurology, Neurosurgery and Medical Oncology, University of Pittsburgh, Pittsburgh, Pennsylvania.
authors.forename: Frank S
authors.initials: FS
authors.lastname: Lieberman
authors.affiliation: Departments of Radiation Oncology, Otolaryngology, and Neurosurgery, University of Iowa, Iowa City, Iowa.
authors.forename: John M
authors.initials: JM
authors.lastname: Buatti
authors.affiliation: Division of Nuclear Medicine, Department of Radiology, University of Pittsburgh, Pittsburgh, Pennsylvania.
authors.forename: James M
authors.initials: JM
authors.lastname: Mountz
authors.affiliation: Department of Radiology, Mayo Clinic, Rochester, Minnesota.
authors.forename: Bradley J
authors.initials: BJ
authors.lastname: Erickson
authors.affiliation: Department of Radiology, Brigham and Women's Hospital, Boston, Massachusetts.
authors.forename: Fiona M M
authors.initials: FM
authors.lastname: Fennessy
authors.affiliation: Advanced Imaging Research Center, Oregon Health and Science University, Portland, Oregon.
authors.forename: Wei
authors.initials: W
authors.lastname: Huang
authors.affiliation: Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts.
authors.forename: Jayashree
authors.initials: J
authors.lastname: Kalpathy-Cramer
authors.affiliation: Department of Radiology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Richard L
authors.initials: RL
authors.lastname: Wahl
authors.affiliation: Department of Medicine, University of Washington, Seattle, Washington.
authors.forename: Hannah M
authors.initials: HM
authors.lastname: Linden
authors.affiliation: Department of Radiology, University of Washington, Seattle, Washington.
authors.forename: Paul E
authors.initials: PE
authors.lastname: Kinahan
authors.affiliation: Department of Radiology, Columbia University, New York, New York.
authors.forename: Binsheng
authors.initials: B
authors.lastname: Zhao
authors.affiliation: Department of Radiology, University of California, San Francisco, San Francisco, California.
authors.forename: Nola M
authors.initials: NM
authors.lastname: Hylton
authors.affiliation: Department of Radiology, H. Lee Moffitt Cancer Center and Research Institute, Tampa Bay, Florida.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Gillies
authors.affiliation: Cancer Imaging Program, National Cancer Institute, Bethesda, Maryland.
authors.forename: Laurence
authors.initials: L
authors.lastname: Clarke
authors.affiliation: Cancer Imaging Program, National Cancer Institute, Bethesda, Maryland.
authors.forename: Robert
authors.initials: R
authors.lastname: Nordstrom
authors.affiliation: Department of Radiology and Medicine, Stanford University, Palo Alto, California.
authors.forename: Daniel L
authors.initials: DL
authors.lastname: Rubin
mesh_terms: D002986:Clinical Trials as Topic; D005069:Evaluation Studies as Topic; D006801:Humans; D057054:Molecular Imaging / Q000379:methods; D058990:Molecular Targeted Therapy / Q000379:methods; D009369:Neoplasms / Q000188:drug therapy* / Q000473:pathology*