Translational Multimodality Optical Imaging

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1 Translational Multimodality Optical Imaging Fred S. Azar Xavier Intes Editors 0 ARTECH H O U S E BOSTON LONDON artechhouse.com

2 Contents Foreword Preface xv xvii CHAPTER1 Introduction to Clinical Optical Imaging Introduction Tissue Optics Scattering Raman Scattering Absorption Fluorescence Light Propagation Fundamentals Forward Model Multimodality Imaging A Brief History of Clinical Multimodality Imaging Multimodality Optical Imaging Conclusions 13 References 13 CHAPTER 2 In Vivo Microscopy Introduction Confocal Microscopy Endoscope-Compatible Systems MKT Cellvizio-GI Dual-Axes Confocal Microscope Molecular Imaging 27 References 30 CHAPTER 3 Endoscopy Introduction Point-Probe Spectroscopy Techniques Scattering Spectroscopy Fluorescence Spectroscopy Raman Spectroscopy 38 VII

3 VIII Contents Multimodality Spectroscopy Wide-Field Imaging Fluorescence Imaging Molecular Imaging Chromoendoscopy Narrowband Imaging Multimodality Wide-Field Imaging Cross-Sectional Imaging Endoscopic Optical Coherence Tomography Ultrahigh-Resolution OCT (UHROCT) Three-Dimensional OCT Multimodality Imaging with OCT Summary 51 Acknowledgments 51 References 51 CHAPTER 4 Diffuse Optical Techniques: Instrumentation Introduction: Deterministic "Diffuse" Detection of ProbabÜistic Photon Propagation Methods of Differentiating the Origin of Diffuse Photons The Source-Encoding Requirement in DOT Methods of Source Encoding and Detector Decoding for Diffuse Optical Tomography Techniques of Decoupling the Absorption and Scattering Contributions to the Photon Remission Time-Domain Detection Frequency-Domain Detection Continuous-Wave Detection Principles of Determining the Heterogeneity of Optical Properties Tomographie Image Reconstruction and Prior Utilization Diffuse Optical Tomography Imaging in the Context of Multimodality Imaging Novel Approaches in Instrumentation of Diffuse Optical Tomography: Source Spectral Encoding Discrete Spectral Encoding by Use of Multiple Laser Diodes Imaging Examples of Spectral-Encoding Rapid NIR Tomography Spread Spectral Encoding by Use of Single Wideband Light Source Light Sources for Spread Spectral Encoding Characteristics of Spread Spectral Encoding Hemodynamic Imaging by Spread-Spectral-Encoding NIR Tomography Novel Approaches in Instrumentation of Diffuse Optical Tomography: Transrectal Applicator Transrectal Applicator for Transverse DOT Imaging Transrectal Applicator for Sagittal DOT Imaging 88

4 Contents IX 4.7 Potential Directions of Instrumentation for Diffuse Optical Measurements Conclusions 94 Acknowledgments 94 References, 94 CHAPTER 5 Multimodal Diffuse Optical Tomography: Theory Introduction Diffuse Optical Tomography The Forward Problem and Linearization Inverse Problem Multimodality Reconstruction: Review of Previous Work Multimodality Priors and Regularization Structural Priors Regularization Using Mutual Information Conclusions 119 Acknowledgments 119 References 120 CHAPTER 6 Diffuse Optical Spectroscopy with Magnetic Resonance Imaging Introduction Anatomical Imaging Combining Hemodynamic Measures of MRI and Optical Imaging MRI-Guided Optical Imaging Reconstruction Techniques Other MR-Derived Contrast and Optical Imaging Hardware Challenges to Merging Optical and MRI Optical/MR Contrast Agents Outlook for MR-Optical Imaging 136 References 136 CHAPTER 7 Software Platforms for Integration of Diffuse Optical Imaging and Other Modalities Introduction A Platform for Diffuse Optical Tomography A Platform for Diffuse Optical Spectroscopy Imaging Platform Technologies Multimodal Imaging Workflow for DOT Applications D-DOT/3D-MRI Image-Registration Algorithm Breast MRI Image Segmentation Image-Based Guidance Workflow and System for DOS Applications Computing the Accuracy of a Guidance and Tracking System Global Accuracy of the System Motion Tracking 154

5 X Contents 7.4 Application to Nonconcurrent MRI and DOT Data of Human Subjects Conclusion 157 Acknowledgments 158 References 158 Selected Bibliography 162 CHAPTER 8 Diffuse Optical Spectroscopy in Breast Cancer: Coregistration with MRI and Predicting Response to Neoadjuvant Chemotherapy Introduction Coregistration with MRI Materials and Methods Results Discussion Monitoring and Predicting Response to Breast Cancer Neoadjuvant Chemotherapy Materials and Methods Results Discussion Summary and Conclusions 181 Acknowledgments 182 References 182 CHAPTER 9 Optical Imaging and X-Ray Imaging Introduction Current Clinical Approach to Breast Cancer Screening and Diagnosis The Importance of Fusing Function and Structural Information Recent Advances in DOT for Imaging Breast Cancer Instrumentation and Methods Tomographie Optical Breast-Imaging System and Tomosynthesis D Forward Modeling and Nonlinear Image Reconstruction Simultaneous Image Reconstruction with Calibration Coefficient Estimation Utilizing Spectral Prior and Best Linear Unbiased Estimator Utilizing Spatial Prior from Tomosynthesis Image Clinical Trial of TOBI/DBT Imaging System Image Reconstruction of Healthy Breasts Imaging Breasts with Tumors or Benign Lesions Region-of-Interest Analysis Dynamic Imaging of Breast Under Mechanical Compression Experiment Setup Tissue Dynamic from Healthy Subjects 195

6 XI Contact Pressure Map Under Compression Conclusions 198 References 199 CHAPTER 10 Diffuse Optical Imaging and PET Imaging Introduction Positron Emission Tomography (PET) PET Fundamentals PET Image Reconstruction PET Instrumentation Diffuse Optical Imaging (DOI) DOI Instrumentation DOI Image Reconstruction Fluorescence Diffuse Optical Imaging (FDOI) Clinical Observations Whole-Body PET and DOI Breast-Only PET and DOI ICG Fluorescence Summary 219 Acknowledgments 220 References 220 CHAPTER 11 Photodynamic Therapy Introduction Basics ofpdt Superficial Applications PDT in Body Cavities PDT for Solid Tumors Delivery and Monitoring of PDT 235 \\.7 TVie TFuture ot TOT and Imaging 236 Acknowledgments 236 References 236 CHAPTER12 Optical Phantoms for Multimodality Imaging Introduction Absorption and Scatter Phantom Composition Typical Tissue Phantoms for Multimodal and Optical Imaging Hydrogel-Based Phantoms Polyester Resin and RTV Silicone Phantoms Aqueous Suspension Phantoms Conclusions 253 Acknowledgments 254 References

7 XII Contents CHAPTER 13 Intraoperative Near-Infrared Fluorescent Imaging Exogenous Fluorescence Contrast Agents Introduction Unmet Medical Needs Addressed by Intraoperative NIR Fluorescence Imaging Improving Long-Term Efficacy of Primary Treatment Reducing the Rate of Complications Imaging Considerations Contrast Media Tissue Penetration Depth Autofluorescence Optical Design Considerations Excitation Collection Optics and Emission Filtering Detectors Future Outlook 268 References 269 CHAPTER14 Clinical Studies in Optical Imaging: An Industry Perspective Introduction Breast Cancer Optical Breast-Imaging Technology Development Process Product Definition Clinical Indication Target Markets Regulatory Risk Classification General Device Description Design Control Clinical Trials and Results Clinical Plan Pilot Studies Tissue-Characterization Trials Conclusions 294 Acknowledgments 294 References 295 CHAPTER 15 Regulation and Regulatory Science for Optical Imaging Introduction Fundamental Concepts in Medical Device Regulation Premarket and Postmarket Safety Effectiveness Risk Evaluation 301

8 Contents *'» Labeling Standards Medical Device Regulation Throughout the World International Harmonization of Medical Device Regulation FDA Background FDA Mission FDA History and Authorizing Legislation Organizational Structure of the FDA Overview of FDA Regulations Classification Early Premarket Interactions Premarket Submissions Postmarket Issues Combination Products and Contrast Agents Regulatory Submission Aids Good Practices Regulatory Science: Optical Safety Hazards Photochemical Damage Photosensitivity Photothermal Effects Photomechanical Damage Conclusions 322 Acknowledgments 322 References 322 CHAPTER 16 Emerging Optical Imaging Technologies: Contrast Agents Introduction Optical Probes Fluorophores as Contrast Agents for Optical Imaging Fluorophore Conjugates for Targeting and Activation Fluorescent Nanoparticles Multimodality Probes for Optical Imaging Probes for Optical Imaging and MRI Probes for Optical Imaging and SPECT/PET Probes for Optical Imaging and Therapy Summary and Conclusions 337 References 337 CHAPTER17 Emerging Optical Imaging Techniques: Fluorescence Molecular Tomography and Beyond Introduction From Planar Imaging to Tomography Prerequisites Bioluminescence and Fluorescence Imaging Data-Collection Modes 345

9 XIV Contents 17.3 Fluorescence Molecular Tomography Hardware Development Image Reconstruction Intrinsic Resolution Limits FMT-Derived Imaging Modalities Noncontact FMT Fluorescent Protein Tomography Mesoscopic Fluorescence Tomography Further Developments Photoacoustic Tomography Photoacoustic Theory Combined FMT-PAT Imaging Summary 357 References 359 CHAPTER 18 From Benchtop to Boardroom: Staying Market Focused Identify the Market Technology Alone Has Little Value Find a Business Mentor Teil a Story Using the Right Terms Focus Is the Key Build Value Conclusions 367 References 368 About the Editors 369 List of Contributors 371 Index 375

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