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Molecular Imaging Comes of Age

Applications and Impacts in Discovery, Clinical Trials, and Medical Practice

Publication Date   October 2004
Publisher   Cambridge Healthtech Advisors
Product Type   Report
Pages   126
ISBN Number   not applicable
Product Code   CHA008
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Summary


The advent of molecular imaging has prompted a rapid and thorough change in the medical imaging market, supplanting purely structural information with invaluable functional data. Molecular Imaging Comes of Age: Applications and Impacts in Discovery, Clinical Trials, and Medical Practice provides keen insight into the technologies destined to form the basis of healthcare during the next five years. 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 that highlight the attitudes of scientists and managers towards specific issues. 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: Applications and Impacts in Discovery, Clinical Trials, and Medical Practice evaluates the applications of various technologies 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 to use drugs in a more targeted fashion, molecular imaging’s core role for the pharmaceutical industry is in drug discovery and development. The report examines ways in which pure research is already profiting vastly 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 which 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 because this approach can operate against the background of basic molecular imaging research that has already been conducted in the respective disease. The report discusses the general regulatory issues that will impact the use of imaging agents in clinical trials.

Content


Glossary of Acronyms
Executive Summary

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 Alzheimer’s 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 Bio’s INDIMACIS 125

SPECT Receptor Imaging Agents for Neuroendocrine Tumors
Mallinckrodt Medical’s OctreoScan
Diatide’s NeoSpect / Neotect (Technetium-99m depreotide)
Draximage’s Iodine-123- Iobenguane (metaiodobenzylguanidine, MIBG)

Colon Cancer
Immunomedics, Inc.'s CEA-Scan (arcitumomab).

Prostate Cancer
Cytogen’s 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 Technology’s AmiScan
Draximage’s Fibrimage
Investigational Agents

3.5. Inflammation and Infection
Numerous Applications, Limited MI Options
Palatin Technologies’ NeutroSpec (Leutech; [99mTc]-fanolesomab).
Draximage’s Infecton (Tc-99m labeled ciprofloxacin)

Investigational Agents
LeukoScan (Tc-99m sulesomab)
Tc-99m-RP-128
Tc-99m RP-517

3.6. Parkinson’s Disease
3.7. Summary

CHAPTER 4 – Molecular Imaging in Research and Development


4.1. Molecular Imaging as an Integral Part of Clinical Development
Brain Disorders
Alzheimer’s Disease
Parkinson’s 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