Imaging as a tool in drug development

Drugs of Today

Volumn 43, Issue 10, 2007, Pages 725-736

  Strack, Thomas ^a  

^a PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; ALENDRONIC ACID; ALPHA 1 ANTITRYPSIN; ANTINEOPLASTIC AGENT; ATORVASTATIN; AXITINIB; BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; BEVACIZUMAB; CHOLINERGIC RECEPTOR BLOCKING AGENT; CORTICOSTEROID; CROMOGLYCATE DISODIUM; DEOXYRIBONUCLEASE; ERLOTINIB; FLUORO MISONIDAZOLE F 18; FLUORODEOXYGLUCOSE F 18; GADOLINIUM PENTETATE MEGLUMINE; GEFITINIB; IBANDRONIC ACID; IBRITUMOMAB TIUXETAN; IMATINIB; N SEC BUTYL 1 (2 CHLOROPHENYL) N METHYL 3 ISOQUINOLINECARBOXAMIDE; NEDOCROMIL; OXALIPLATIN; RADIOISOTOPE; RALOXIFENE; SUNITINIB; TAMOXIFEN; TECHNETIUM 99M; UNCLASSIFIED DRUG; UNINDEXED DRUG; VASCULOTROPIN INHIBITOR;

ADVANCED CANCER; BREAST CANCER; CANCER CHEMOTHERAPY; CANCER SURGERY; CLINICAL PRACTICE; COLON CANCER; COLORECTAL CANCER; COMPUTER ASSISTED TOMOGRAPHY; CYSTIC FIBROSIS; DIAGNOSTIC ACCURACY; DIAGNOSTIC IMAGING; DRUG APPROVAL; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG HALF LIFE; DRUG MECHANISM; DRUG TARGETING; FOOD AND DRUG ADMINISTRATION; FUNCTIONAL MAGNETIC RESONANCE IMAGING; HUMAN; INTERMETHOD COMPARISON; LUNG DISEASE; LUNG EMPHYSEMA; NONHODGKIN LYMPHOMA; NONHUMAN; OSTEOPOROSIS; POSITRON EMISSION TOMOGRAPHY; PRACTICE GUIDELINE; RECURRENT DISEASE; REVIEW; RHEUMATOID ARTHRITIS; RISK ASSESSMENT; SINGLE PHOTON EMISSION COMPUTER TOMOGRAPHY; ULTRASOUND; WORLD HEALTH ORGANIZATION;

DRUG APPROVAL; DRUG DELIVERY SYSTEMS; DRUG DESIGN; HUMANS; MAGNETIC RESONANCE IMAGING; POSITRON-EMISSION TOMOGRAPHY; RESEARCH DESIGN;

EID: 36849052336     PISSN: 16993993     EISSN: 16994019     Source Type: Journal    
DOI: 10.1358/dot.2007.43.10.1148060     Document Type: Review

References (86)

1. Rudin, R., Weissleder, R. Molecular imaging in drug discovery and development. Nature Rev 2003, 2: 123-31.
2. Massoud, T.F., Gambhir, S.S. Molecular imaging in living subjects: seeing fundamental biological processes in a new light. Genes & Development 2003, 17: 545-80.
3. Sharp, J.T., Young, D.Y., Bluhm, G.B. et al. How many joints in the hands and wrists should be included in a score of radiologic abnormalities used to assess rheumatoid arthritis? Arthritis Rheum 1985, 28(12): 1326-35.
4. Ettinger, B., Black, D.M., Mitlak, B.H. et al. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: Results from a 3-year randomized clinical trial. Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators. JAMA 1999, 282(7): 637-45.
5. Chen, P., Miller, P.D., Delmas, P.D., Misurski, D.A., Krege, J.H. Change in lumbar spine BMD and vertebral fracture risk reduction in teriparatide-treated postmenopausal women with osteoporosis. J Bone Miner Res 2006, 21: 1785-90.
6. Black, D.M., Thompson, D.E. The effect of alendronate therapy on osteoporotic fracture in the vertebral fracture arm of the Fracture Intervention Trial. Int J Clin Pract (Suppl.) 1999, 101: 46-50.
7. Ringe, J.D., Dorst, A., Faber, H., Ibach, K., Sorenson, F. Intermittent intravenous ibandronate injections reduce vertebral fracture risk in corticosteroid-induced osteoporosis: results from a long-term comparative study. Osteoporos Int 2003, 14(10): 801-7.
8. Early Breast Cancer Trialists' Collaborative Group. Tamoxifen for early breast cancer: An overview of the randomised trials. Lancet 1998, 351(3): 1451-67.
9. Therasse, P., Arbuck, S.G., Eisenhauer, E.A. et al. New guidelines to evaluate the response to treatment in solid tumours. J Natl Cancer Inst 2000, 92: 205-16.
10. Ratain, M.J., Eckhardt, S.G. Phase II studies of modern drugs directed against new targets: if you are fazed, too, then resist RECIST. J Clin Oncol 2004, 22(22): 4442-5.
11. Rudin, M., Beckmann, N., Porszasz, R., Reese, T., Bochelen, D., Sauter, A. In vivo magnetic resonance methods in pharmaceutical research: current status and perspectives. NMR Biomed 1999, 12(2): 69-97.
12. Cherry, S.R. Fundamentals of positron emission tomography and applications in preclinical drug development. J Clin Pharmacol 2001, 41(5): 482-91.
13. Phelps, M.E., Huang, S.C., Hoffman, E.J. et al. Tomographic measurement of local cerebral glucose metabolic rate in humans with (F-18)2-fluoro-2-deoxy-D-glucose: Validation of method. Ann Neurol 1979, 6(5): 371-88.
14. Huang, S.C., Phelps, M.E., Hoffman, E.J. et al. Noninvasive determination of local cerebral metabolic rate of glucose in man. Am J Physiol 1980, 238(1): E69-82.
15. 14C] deoxyglucose method for the measurement of local cerebral glucose utilization: theory, procedure, and normal values in the conscious and anesthetized albino rat. J Neurochem 1977, 28(5): 897-916.
16. Fishman, A., Bonab, A., Babich, J. et al. Positron emission tomographic analysis of central 5-hydroxytryptamine 2 receptor occupancy in healthy volunteers treated with the novel antipsychotic agent ziprasidone. J Pharmacol Exp 1996; 279: 939-947.
17. Passhier, J., van Waarde, A. Visualization of serotonin-1A (5-HT1A) receptors in the central nervous system. Eur J Nucl Med 2001, 28: 113-29.
18. Martinez, D., Hwang, D.-R., Mawlawi, O. et al. Differential occupancy of somatodendritic and postsynaptic 5HT(1A) receptors by pindolol: a dose occupancy study with 11C WAY 100635 and positron emission tomography in humans. Neuropsychopharmacol 2001, 24: 209-29.
19. Bench, C.J., Lammerstma, A.A., Grasby, P.M. et al. The time course of binding to striatal dopamine D2 receptors by the neurileptic ziprasidone (CP-88,059-01) determined by positron emission tomography. Psychopharmacol 1996, 124: 141-7.
20. Volkow, N.D., Fowler, J.S., Gatley, S.J., Logan, J., Wang, G.J., Ding, Y.S., Dewey, S. PET evaluation of the dopamine system of the human brain. J Nucl Med 1996, 37(7): 1242-56.
21. Warburg, O., Posener, K., Negelein, E. Über den Stoffwechsel der Carcinomzelle. Biochem Zeitschrift 1924, 152: 309-35.
22. Smith, T.A. Facilitative glucose transporter expression in human cancer tissue. Br J Biomed Sci 1999, 56(4): 285-92.
23. Smith, T.A. Mammalian hexokinases and their abnormal expression in cancer. Br J Biomed Sci 2000, 57(2): 170-8.
24. Di Chiro, G. Positron emission tomography using [18F] fluorodeoxyglucose in brain tumors. A powerful diagnostic and prognostic tool. Invest Radiol 1987, 22(5): 360-71.
25. Goshen, E., Davidson, T, Zwas, S.T., Aderka, D. PET/CT in the evaluation of response to treatment of liver metastases from colorectal cancer with bevacizumab and irinotecan. Technology in Cancer Research and Treatment 2006, 5(1): 37-43.
26. Martin, G.V., Caldwell, J.H., Rasey, J.S., Grunbaum, Z., Cerqueira, M., Krohn, K.A. Enhanced binding of the hypoxic cell marker [3H] fluoromisonidazole in ischemic myocardium. J Nuclear Med 1989, 30: 194-201.
27. Hoffman, J.M., Rasey, J.S., Spence, A.M., Shaw, D.W., Krohn, K.A. Binding of the hypoxia tracer [3H]misonidazole in cerebral ischemia. Stroke 1987, 18(1): 168-76.
28. Tatum, J.L., Kelloff, G.J., Gillies, R.J. Hypoxia: Importance in tumor biology, noninvasive measurement by imaging, and value of its measurement in the management of cancer therapy. Int J Radiat Biol 2006, 82(10): 699-757.
29. Barthel, H., Wilson, H., Collingridge, D.R. et al. In vivo evaluation of [18F]fluoroetanidazole as a new marker for imaging tumour hypoxia with positron emission tomography. British Journal of Cancer 2004, 90(11): 2232-42.
30. Rasey, J.S., Hofstrand, P.D., Chin, L.K., Tewson, T.J. Characterization of [18F]fluoroetanidazole, a new radiopharmaceutical for detecting tumor hypoxia. J Nucl Med 1999, 40(6): 1072-9.
31. Tatum, J.L., Kelloff, G.J, Gillies, R.J. Hypoxia: Importance in tumor biology, noninvasive measurement by imaging, and value of its measurement in the management of cancer therapy. Int J Radiat Biol 2006, 82(10): 699-757.
32. Joensuu, H., Roberts, P.J., Sarlomo-Rikala, M. et al. Effect of tyrosine kinase inhibitor STI571 in a patient with metastatic gastrointestinal stromal tumor. New Engl J Med 2001, 344(14): 1052-6.
33. Demetri, G.D., George, S., Heinrich, M.C. et al. Clinical activity and tolerability of the multi-targeted tyrosine kinase inhibitor SU11248 in patients with metastatic gastrointestinal stromal tumor (GIST) refractory to imatinib mesylate (abstract). Proc Am Soc Clin Oncol 2003, #3273.
34. Goshen, E., Davidson, T., Zwas, S.T., Aderka, D. PET/CT in the evaluation of response to treatment of liver metastases from colorectal cancer with bevacizumab and irinotecan. Technol Cancer Res Treat 2006, 5(1): 37-43.
35. Rudd, J.H., Warburton, E.A., Fryer, T.D. et al. Imaging atherosclerotic plaque inflammation with [18F]-fluorodeoxyglucose positron emission tomography. Circulation 2002, 105(23): 2708-11.
36. 18FDG uptake with vascular calcification. J Nucl Med 2005, 46(8): 1278-84.
37. Ojima, R, Ido, T., Takahashi, T. et al. Preparation of a fine powder of 2-deoxy-2-[18F]fluoro-D-glucose suitable for inhalation to diagnose lung diseases by means of PET. Ann Nucl Med 1989, 3(3): 143-7.
38. 18F FDG powder. J Comput Assist Tomogr 1990, 14(2): 175-81.
39. 18FDG powder in patients with chronic obstructive disease. Eur Respir J 1998, 11(6): 1342-8.
40. Lee, Z., Berridge, M.S., Finlay, W.H., Heald, D.L. Mapping PET-measured triamcinolone acetonide (TAA) aerosol distribution into deposition by airway generation. Int J Pharm 2000, 199: 7-16.
41. Berridge, M.S., Lee, Z., Heald, D.L. Pulmonary distribution and kinetics of inhaled [11C] triam cinolone acetonide. J Nucl Med 2000, 41(10): 1603-11.
42. Aigbirhio, F.I., Carr, R.M., Pike, V.W., Steel, C.J., Sutherland, D.R. Automated radiosynthesis of no-carrier-added [S-fluoromethyl-F-18]fluticasone propionate as a radiotracer for lung deposition studies with PET. J Labelled Compd Radiopharm 1997, 39: 567-84.
43. 11C]zanamivir following administration as an intranasal spray. Evaluation with positron emission tomography. Clin Pharmacokinet 1999, 36 (Suppl. 1): 33-9.
44. 11C-nicotine vapor in the human airway as visualized by positron emission tomography. Clin Pharmacol Ther 1995, 57(3): 309-31.
45. Berridge, M.S., Lee, Z., Heald, D.L. Regional distribution and kinetics of inhaled pharmaceuticals. Current Pharmaceutical Design 2000, 6(16): 1631-51.
46. 19F-Labeled Insulin: A New Radiotracer for PET-based Molecular Imaging Studies. J Med Chem 2006, 49(4): 1466-74.
47. Massoud, T.F., Gambhir, S.S. Molecular imaging in living subjects: seeing fundamental biological processes in a new light. Genes & Development 2003, 17: 545-80.
48. http://www.snidd.org/
49. Damadian, R. Tumour detection by nuclear magnetic resonance. Science 1971, 171(976): 1151-3.
50. Ogawa, S., Lee, T.M., Kay, A.R., Tank, D.W. Brain magnetic resonance imaging with contrast dependent on blood oxygenation. Proc Natl Acad Sci USA 1990, 87(24): 9868-72.
51. Turner, R. Magnetic resonance imaging of brain function. Am J Physiol Imaging 1992, 7(3-4): 136-45.
52. Skolnick, A.A. New MRI techniques allow non-invasive peek inside the thinking human brain. JAMA 1992, 26811): 1387-8.
53. Plum, F., Posner, J.B., Troy, B. Cerebral metabolic and circulatory responses to induced convulsions in animals. Arch Neurol 1968, 18(1): 1-13.
54. Posner, J.B., Plum, F., Van Poznak, A. Cerebral metabolism during electrically induced seizures in man. Arch Neurol 1969, 20(4): 388-95.
55. Fox, P.T., Raichle, M.E. Stimulus rate determines regional brain blood flow in striate cortex. Ann Neurol 1985, 17(3): 303-5.
56. Rosen, B.R., Belliveau, J.W., Chien, D. Perfusion imaging by nuclear magnetic resonance. Magn Reson Q 1989, 5(4): 263-81.
57. Belliveau, J.W., Kennedy, D.N. Jr., McKinstry, R.C. et al. Functional mapping of the human visual cortex by magnetic resonance imaging. Science 1991, 254(5032): 716-9.
58. Tofts, P.S., Brix, G., Buckley, D.L. et al. Estimating kinetic parameters from dynamic contrast-enhanced T(1)-weighted MRI of a diffusable tracer: standardized quantities and symbols. J Magn Res Imaging 1999, 10: 223-32.
59. Daldrup-Link, H.E., Shames, D.M., Wendland, M., Muhler, A., Gossmann, A., Rosenau, R., Brasch, R.C. Comparison of Gadomer-17 and gadopentetate dimeglumine for differentiation of benign from malignant breast tumors with MR imaging. Acad Radiol 2000, 7(11): 934-44.
60. Helbich, T.H., Roberts, T.P., Gossmann, A. et al. Quantitative gadopentetate-enhanced MRI of breast tumors: Testing of different analytic methods. Magn Res Med 2000, 44: 915-24.
61. Su, M.Y., Wang, Z., Carpenter, P.M., Lao, X., Muhler, A., Nalcioglu, O. Characterization of N-ethyl-N-nitrosourea-induced malignant and benign breast tumors in rats by using three MR contrast agents. J Magn Res Imaging 1999, 9: 177-86.
62. Bhujwalla, Z.M., Artemov, D., Natarajan, K., Ackerstaff, E., Solaiyappan, M. Vascular differences detected by MRI for metastatic versus nonmetastatic breast and prostate cancer xenografts. Neoplasia 2000, 3: 143-53.
63. He, Q., Xu, R.Z., Shkarin, P. et al. Magnetic resonance spectroscopic imaging of tumor metabolic markers for cancer diagnosis, metabolic phenotyping, and characterization of tumor microenvironment. Disease Markers 2003, 19(2-3): 69-94.
64. Jordan, B.F., Runquist, M., Raghunand, N. et al. Dynamic contrast enhanced and diffusion MRI show rapid and dramatic changes in tumor microenvironment in response to inhibition of HIF-1 alpha using PX-478. Neoplasia 2005, 7(5): 475-85.
65. Liu, G., Rugo, H.S., Wilding, G. et al. Dynamic contrast-enhanced magnetic resonance imaging as a pharmacodynamic measure of re sponse after acute dosing of AG-013736, an oral angiogenesis inhibitor, in patients with advanced solid tumors: results from a phase I study. J Clin Oncol 2005, 23(24): 5464-73.
66. Backhaus, M., Kamradt, T., Sandrock, D. et al. Arthritis of the finger joints: a comprehensive approach comparing conventional radiography, scintigraphy, ultrasound, and contrast-enhanced magnetic resonance imaging. Arthritis Rheum 1999, 42(6): 1232-45.
67. Goupille, P., Roulot, B., Akoka, S. et al. Magnetic resonance imaging: a valuable method for the detection of synovial inflammation in rheumatoid arthritis. J Rheumatol 2001, 28(1): 35-40.
68. Benton, N., Stewart, N., Crabbe, J., Robinson, E., Yeoman, S., McQueen, F.M. MRI of the wrist in early rheumatoid arthritis can be used to predict functional outcome at 6 years. Ann Rheum Dis 2004, 63(5): 555-61.
69. Brown, A.K., Quinn, M.A., Karim, Z. et al. Presence of significant synovitis in rheumatoid arthritis patients with disease-modifying antirheumatic drug-induced clinical remission. Evidence from an imaging study may explain structural progression. Arthritis Rheum 2006, 54(12): 3761-73.
70. Peterfy, C.G. Magnetic resonance imaging of rheumatoid arthritis: the evolution of clinical applications through clinical trials. Semin Arthritis Rheum 2001, 30(6): 375-96.
71. Hunter, D.J., Conaghan, P.G., Peterfy, C.G. et al. Responsiveness, effect size, and smallest detectable difference of Magnetic Resonance Imaging in knee osteoarthritis. Osteoarthr Cartil 2006, 14 (Suppl. 1): 112-5.
72. Peterfy, C.G. Role of MR imaging in clinical research studies. Semin Musculoskelet Radiol 2001, 5(4): 365-78.
73. Yonemura, A., Momiyama, Y., Fayad, Z.A. et al. Effect of lipid-lowering therapy with atorvastatin on atherosclerotic aortic plaques detected by noninvasive magnetic resonance imaging. J Am Coll Cardiol 2005, 45(5): 733-42.
74. Kooi, M.E., Cappendijk, V.C., Cleutjens, K.B et al. Accumulation of ultrasmall superparamagnetic particles of iron oxide in human atherosclerotic plaques can be detected by in vivo magnetic resonance imaging. Circulation 2003, 107(19): 2453-8.
75. Trivedi, R.A., U-King-Im, J.M., Graves, M.J. et al. In vivo detection of macrophages in hu man carotid atheroma: temporal dependence of ultrasmall superparamagnetic particles of iron oxide-enhanced MRI. Stroke 2004, 35(7): 1631-5.
76. Cunningham, C.H., Arai, T., Yang, P.C., McConnell, M.V., Pauly, J.M., Conolly, S.M. Positive contrast magnetic resonance imaging of cells labeled with magnetic nanoparticles. Magn Reson Med 2005, 53(5): 999-1005.
77. Jaffer, F., Nahrendorf, M., Sosnovik, D., Kelly, K.A., Aikawa, E., Weissleder, R. Cellular imaging of inflammation in atherosclerosis using magnetofluorescent nanomaterials. Mol Imaging 2006, 5(2): 85-92.
78. http://www.controlled-trials.com/cctspringview2/mrct/showTrial.html?mrid= 239665&srch
79. Hyafil, F., Cornily, J.C., Feig, J.E. et al. Noninvasive detection of macrophages using a nanoparticulate contrast agent for computed tomography. Nature Medicine 2007, 13(5): 636-41.
80. 131 tositumomab. Oncogene 2007, 26(25): 3614-28.
81. Pauwels, E.K.J., Erba, P. Radioimmunotherapy of non-Hodgkin's lymphoma: molecular targeting and novel agents. Drug News Perspect 2007, 20: 87-93.
82. Wängler, C., Buchmann, I., Eisenhut, M., Haberkorn, U., Mier, W. Radiolabeled peptides and proteins in cancer therapy. Protein Pept Lett 2007, 14(3): 273-9.
83. http://www.fda.gov/oc/initiatives/criticalpath/Mills/mills.html
84. Kelloff, G.J., Krohn, K.A., Larson, S.M. et al. The progress and promise of molecular imaging probes in oncologic drug development. Clin Cancer Res 2005, 11(22): 7967-85.
85. http://www.fda.gov/oc/mous/domestic/FDA-NCI-CMS.html
86. Cherry, S.R. Fundamentals of positron emission tomography and applications in preclinical drug development. J Clin Pharmacol 2001, 41(5): 482-91.