The data analysis and modeling group provides mathematical analysis of the kinetics of biodistribution of radiopharmaceutical as both a research and a service component. In particular, we will extend residue analysis to each of the projects over the next five years and apply novel heterogeneity analysis to the characterization of tumors using PET imaging. The clinical utility of image-based information needs to be tested in terms of what additional information the PET-derived measurements contribute to the prediction of patient outcome at the treatment planning stage. Each of our hypotheses describes an observational study with imaging data, assays of relevant biomarkers, and measures of patient response/survival. Our goal is to identify imaging procedures where a clinically important improvement in predictive accuracy, beyond that attained with existing clinical and diagnostic methods, can be achieved. Because the improved prediction will have clear therapeutic implications and our results will pave the way for these hypotheses to be tested in future cooperative clinical trials, the consultants in biostatistics play a critical role in focusing protocols and directing data analysis in anticipation of cooperative prospective trials. In order to increase the level of biostatistical involvement in protocol design and hypothesis testing, this new data analysis core will include a sub-contract with F O'Sullivan and the local leadership of M Muzi and D Mankoff plus new effort by L Kessler that are essential to the quality and overall productivity of our research program. It will build on our research to generalize the role of the more well established imaging agents through several smaller patient trials in a range of tumor histologies. Our goal is to develop a strategy to convince the cancer community in general and FDA in particular that mechanistically validated imaging agents can be used in parallel with new treatment trials. That is, qualification of an imaging agent should not be tumor-specific;it should be validated for a specific characteristic of the tumor phenotype.. Our goal is to make a convincing case that new imaging methods should be engaged in treatment trials sooner rather than later. The recent addition of L Kessler, a health policy expert who recently worked for FDA, to our faculty is important for this objective.

Public Health Relevance

Careful data analysis is essential to extracting the most complete information possible for every imaging study. The new objective of integrating experimental imaging in early clinical trials of therapy should lead to more efficient clinical trials with useful drugs getting to the clinic sooner.

Agency
National Institute of Health (NIH)
Type
Research Program Projects (P01)
Project #
5P01CA042045-25
Application #
8722457
Study Section
Special Emphasis Panel (ZCA1)
Project Start
Project End
Budget Start
Budget End
Support Year
25
Fiscal Year
2014
Total Cost
Indirect Cost
Name
University of Washington
Department
Type
DUNS #
City
Seattle
State
WA
Country
United States
Zip Code
98195
Huang, Jian; O'Sullivan, Finbarr (2014) An analysis of whole body tracer kinetics in dynamic PET studies with application to image-based blood input function extraction. IEEE Trans Med Imaging 33:1093-108
O'Sullivan, Finbarr; Muzi, Mark; Mankoff, David A et al. (2014) VOXEL-LEVEL MAPPING OF TRACER KINETICS IN PET STUDIES: A STATISTICAL APPROACH EMPHASIZING TISSUE LIFE TABLES. Ann Appl Stat 8:1065-1094
Zhou, Dong; Lin, Mai; Yasui, Norio et al. (2014) Optimization of the preparation of fluorine-18-labeled steroid receptor ligands 16alpha-[18F]fluoroestradiol (FES), [18F]fluoro furanyl norprogesterone (FFNP), and 16beta-[18F]fluoro-5alpha-dihydrotestosterone (FDHT) as radiopharmaceuticals. J Labelled Comp Radiopharm 57:371-7
Eary, Janet F; Krohn, Kenneth A (2013) Standards for reporting PET clinical trials. J Nucl Med 54:1516-7
Eary, Janet F; Link, Jeanne M; Muzi, Mark et al. (2011) Multiagent PET for risk characterization in sarcoma. J Nucl Med 52:541-6
Peterson, Lanell M; Kurland, Brenda F; Link, Jeanne M et al. (2011) Factors influencing the uptake of 18F-fluoroestradiol in patients with estrogen receptor positive breast cancer. Nucl Med Biol 38:969-78
Kurland, Brenda F; Peterson, Lanell M; Lee, Jean H et al. (2011) Between-patient and within-patient (site-to-site) variability in estrogen receptor binding, measured in vivo by 18F-fluoroestradiol PET. J Nucl Med 52:1541-9
Hendrickson, Kristi; Phillips, Mark; Smith, Wade et al. (2011) Hypoxia imaging with [F-18] FMISO-PET in head and neck cancer: potential for guiding intensity modulated radiation therapy in overcoming hypoxia-induced treatment resistance. Radiother Oncol 101:369-75
Linden, Hannah M; Kurland, Brenda F; Peterson, Lanell M et al. (2011) Fluoroestradiol positron emission tomography reveals differences in pharmacodynamics of aromatase inhibitors, tamoxifen, and fulvestrant in patients with metastatic breast cancer. Clin Cancer Res 17:4799-805
Dunnwald, Lisa K; Doot, Robert K; Specht, Jennifer M et al. (2011) PET tumor metabolism in locally advanced breast cancer patients undergoing neoadjuvant chemotherapy: value of static versus kinetic measures of fluorodeoxyglucose uptake. Clin Cancer Res 17:2400-9

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