分子影像技術的應用範圍與其對製藥 / 臨床實驗 / 醫療實務面所帶來的影響

本報告已在2011年07月19日停止出版。

簡介

分子影像技術（Molecular Imaging）是一門橫跨生技、製藥、疾病管理的商業領域，每項應用都擁有廣大的市場機會。

專精全球生活科學領域（基因、新藥物等）之最新技術與事業拓展調查，素有高度評價的Insight Pharma Reports（總公司：美國麻州），調查分析了分子影像技術與及應用範圍後，出版了一本綜合報告書 "Molecular Imaging Comes of Age: Applications and Impacts in Discovery, Clinical Trials, and Medical Practice" 。

報告書內容包括：分子影像技術最新動態、未來5年對醫藥保健領域的影響、市場展望等，內容綱要摘記如下：

摘要

1. 分子影像技術基本介紹

• 斷層X光攝影法：虛擬切割（Virtual Slicing）與三維物件重建
• 斷層X光攝影方式的影像技術（CT、MRI）
• Emission斷層X光攝影法（PET、SPECT）
• 構造、功能組合方式之影像技術
• 光學技術（DOT、OCT、CLSM、FCM、FRET等）
• 超音波的極限

2. 分子影像技術的對象與探測

• 分子影像技術對象類別
• 探測與訊號增幅策略

3. 臨床分子影像技術

• 生物標記（Biomarker）的優點
• 一般規範問題對顯影劑的影響
• 癌症：分子影像技術在臨床上的理想應用
• 心臟血管性疾病
• 發炎與感染
• 帕金森症、阿茲海默症
• 總結

4. 研發狀況

• 臨床研發整合之一部份的分子影像技術
• 製藥面的小動物攝影
• 製藥面的分子影像技術與其主要特質

5. 商業化的分子影像技術

• 分子影像技術的臨床市場
• 小動物攝影：發展中的臨床前階段市場
• 分子影像技術市場的一般特徵
• 專家意見（主要8公司）
• 企業資訊（主要12間公司）
• 分子影像技術商業展望

目錄

Abstract

Molecular Imaging Comes of Age: Applications and Impacts in Discovery, Clinical Trials, and Medical Practice provides insight into the technologies that will impact healthcare over the next five years from early research to the delivery of care. The report presents a comprehensive assessment of the latest trends and developments in molecular imaging, enhanced by the insights of opinion leaders from industry and academia. A market outlook completes the analysis.

Molecular imaging has become a business that covers the spectrum from basic cell biology to drug discovery and disease monitoring. The forms in which it has been commercialized are also highly diverse, indicating both substantial growth opportunities for companies competing in this space, as well as new and improved methodologies for researchers. Molecular Imaging Comes of Age evaluates the competing technologies and their applications in three key areas:

Discovery

The pharmaceutical industry has placed a large bet on molecular imaging. While monitoring and guiding of drug therapies with PET will help clinicians to use drugs in a more targeted fashion, molecular imagings core role for the pharmaceutical industry is in drug discovery and development. The report examines ways in which pure research is already profiting from cell-based molecular imaging, which will continue to be based on fluorescence, bioluminescence, and confocal microscopy. Applications in small animal imaging, lead characterization, and lead optimization are also discussed. The insights into basic cell biology that this research is yielding today will form the basis of drug development during the second half of the decade, as the results are absorbed by the pharmaceutical industry.

Clinical Applications

The report highlights clinical applications of molecular imaging technology in cancer, particularly ovarian cancer, as well as cardiovascular disease and inflammation. Experimental clinical applications that reach far beyond these fields, including for instance neuropsychiatry, angiogenesis, and the monitoring of gene therapy are also covered.

Clinical Trials

All regulatory authorities demand that drug developers present a reasonable amount of scientific proof for claims that the candidate compound binds to the designated molecular target, or exerts the expected physiological effect in the target tissue(s). In many cases, molecular imaging will be the method of choice for obtaining such data. The report discusses the general regulatory issues that will impact the use of imaging agents in clinical trials.

Table of Contents

• Chapter 1. The Basics of Imaging Technology
  • 1.1. Tomography: "Virtual Slicing" and Reconstruction of Three-Dimensional Objects
  • 1.2. Tomography-Based Imaging Technologies
    • -Structural Imaging Modalities
      • --Computed Tomography (CT)
      • --Magnetic Resonance Imaging (MRI)
  • 1.3. Emission-Based Tomography Methods
    • -Positron Emission Tomography (PET)
    • -Single-Photon Emission Computed Tomography (SPECT)
  • 1.4. Combined Structural and Functional Imaging Modalities
  • 1.5. Optical Technologies
    • -Diffuse Optical Tomography (DOT)
    • -Optical Coherence Tomography (OCT)
    • -Confocal Laser Scanning Microscopy (CLSM) and its Derivatives
      • --Fluorescence Correlation Microscopy (FCM)
      • --Fluorescence Resonance Energy Transfer (FRET)
      • --Fluorescence Lifetime Imaging (FLIM)
      • --Fluorescence Recovery after Photobleaching (FRAP) and Fluorescence Loss in -Photobleaching (FLIP)
    • -"Standard" Fluorescence and Bioluminescence
    • -Optical Spectroscopy Imaging
  • 1.6. A Limited Role for Ultrasound
• Chapter 2. Molecular Imaging Targets and Probes
  • 2.1. Classes of Targets for Molecular Imaging
    • -Receptors, Ion Channels, and their Functional State
    • -Enzymes
    • -Antigens and Specific Binding Proteins
    • -Nucleic Acids
    • -Pathological Meta-Structures and Disease States
      • --Amyloid in Alzheimers Disease and Amyloidoses
      • --Vulnerable Plaque in Atherosclerosis
      • --Imaging Sites of Inflammation and Apoptosis.
    • -Voltage-Sensitive Dyes
  • 2.2. Probes and Signal Amplification Strategies
    • -Radioactive Tracers for PET, SPECT and Scintigraphy
    • -Molecular Imaging Probes with Visual or Infrared Output
      • --Targeted Beacon Probes
      • --Target-Activated Probes
    • -Bioluminescence: Luciferin/Luciferase
    • -Green Fluorescent Protein (GFP) and its Derivatives
      • --Basics
      • --GFP Variants
• Chapter 3. Molecular Imaging in Clinical Practice
  • 3.1. Advantages as Biomarkers
  • 3.2. General Regulatory Issues Affecting Imaging Agents
  • 3.3. Cancer: An Almost Ideal Clinical Application of Molecular Imaging
    • -Lung Cancer
    • -Breast Cancer
    • --Advanced Research Technologies SoftScan
    • -Ovarian Cancer
      • --CIS Bios INDIMACIS 125
    • -SPECT Receptor Imaging Agents for Neuroendocrine Tumors
      • --Mallinckrodt Medicals OctreoScan
      • --Diatides NeoSpect / Neotect (Technetium-99m depreotide)
      • --Draximages Iodine-123-Iobenguane (metaiodobenzylguanidine, MIBG)
    • -Colon Cancer
      • --Immunomedics, Inc.s CEA-Scan (arcitumomab)
    • -Prostate Cancer
      • --Cytogens ProstaScint
    • -Lymphoma
      • --Immunomedics LymphoScan (bectumomab)
      • --Fluorescence Imaging of Cancer at Accessible Mucosal Sites
  • 3.4. Cardiovascular Disease
    • -Minor but Growing Applications of MI in Cardiovascular Imaging
      • --Draximage/Molecular Targeting Technologys AmiScan
      • --Draximages Fibrimage
      • --Agenixs ThromboView
      • --Investigational Agents
  • 3.5. Inflammation and Infection
    • -Numerous Applications, Limited MI Options
      • --Palatin Technologies NeutroSpec (Leutech; [99mTc]-fanolesomab)
      • --Draximages Infecton (Tc-99m labeled ciprofloxacin)
    • -Investigational Agents
      • --LeukoScan (Tc-99m sulesomab)
      • --Tc-99m-RP-128
      • --Tc-99m RP-517
  • 3.6. Parkinsons and Alzheimers Diseases
  • 3.7. Summary
• Chapter 4. Molecular Imaging in Research and Development
  • 4.1. Molecular Imaging as an Integral Part of Clinical Development
    • Brain Disorders
      • --Alzheimers Disease
      • --Parkinsons Disease
      • --Amyotrophic Lateral Sclerosis
      • --Ischemic Stroke
    • -Monitoring Treatment Response with Cancer Drugs
      • --Malignant Glioma
      • --Monitoring Progression of Pre-Melanoma
      • --A Combined Marker for Glutamatergic Neurotransmission and Prostate Cancer
    • -Peripheral Vascular Disease
    • -Infection
    • -Monitoring Gene Therapy and Advancing Vector Development
      • --Imaging of Transgene-Induced Angiogenesis
      • --Suitability of New Vector Constructs
  • 4.2. Small Animal Imaging in Drug Development
    • -Disease-Specific Applications of Small Animal Imaging
      • --Prion Diseases
      • --p53 Tumor Suppressor Protein
      • --Models for Proto-Oncogenes and Their Ligands
  • 4.3. Molecular Imaging in Drug Discovery and Lead Characterization
    • -Procedure for Using Cell-Based Molecular Imaging
    • -Primary and Secondary Applications of Cell-Based MI in Drug Discovery
      • --Lead Characterization
      • --Lead Optimization
    • -New Avenues Toward Target Validation
    • -Basic Research in Cell Biology
• Chapter 5. Molecular Imaging as a Business
  • 5.1. The Clinical Market for Molecular Imaging
    • -PET as the Dominant Molecular Imaging Modality in Clinical Practice
    • -Combined PET/CT and SPECT/CT Modalities -- Boosters for Clinical Molecular -Imaging
  • 5.2. Small Animal Imaging: An Emerging Key Market for Preclinical Drug Development
  • 5.3. General Characteristics of the Molecular Imaging Market
  • 5.4. Expert Commentaries
    • -Merck
    • -Pfizer
    • -CTI Molecular
    • -Genentech
    • -Stanford
    • -Johns Hopkins
    • -GammaMedica
    • -Novartis
  • 5.5. Selected Company Profiles
    • -Siemens Medical Solutions
    • -GE Healthcare
    • -Philips Medical Systems -- Molecular Imaging Unit
    • -CTI Molecular Imaging
    • -Applied Imaging Corp.
    • -Norak Biosciences, Inc.
    • -GammaMedica, Inc.
    • -Kereos, Inc.
    • -OptoSonics, Inc.
    • -Xenogen Corp.
    • -Molecular Imaging Research, Inc.
    • -Visen Medical, Inc.
  • 5.6. The Business Outlook for Molecular Imaging
• Appendix. Important Societies and Institutions
• Glossary
• Index

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