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  • Perspectives
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The clinical evaluation of novel imaging methods for cancer management

Nature Reviews Clinical Oncology volume 9, pages 738–744 (2012)Cite this article

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Abstract

The National Cancer Institute (NCI) has a long-standing interest in evaluating and using the known advantages of molecular and functional imaging, as well as assessing the potential of novel imaging agents and modalities, to improve clinical cancer research and cancer care. In this Perspectives article, I discuss the strategies and resources being used by the NCI to foster and enhance these evaluations. Although resource and logistical challenges abound in successfully mounting these trials, many examples exist of real and potential solutions to improve the clinical evaluation process for imaging agents and modalities in the USA and in international collaborations.

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Figure 1: Different NCI funding streams for clinical trials in imaging.

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References

  1. Histed, S. N. et al. Review of functional/anatomical imaging in oncology. Nucl. Med. Commun. 33, 349–361 (2012).

    Article  PubMed  PubMed Central  Google Scholar 

  2. Butowski, N. & Chang, S. M. Endpoints for clinical trials and revised assessment in neurooncolgy. Curr. Opin. Neurol. http://dx.doi.org/10.1097/WCO.0b013e328359b45e

  3. Paul, N. S., Ley, S. & Metser, U. Optimal imaging protocols for lung cancer staging: CT, PET, MR Imaging and the role of imaging. Radiol. Clin. North Am. 50, 935–949 (2012).

    Article  PubMed  Google Scholar 

  4. Shankar, L., Menkens, A. & Sullivan, D. in Molecular Targeting in Oncology (eds Kaufman, H. L., Wadler, S. & Antman, K.) 675–692 (Humana Press, Totowa, 2008).

    Book  Google Scholar 

  5. Beyer, T. & Townsend, D. W. Putting 'clear' into nuclear medicine: a decade of PET/CT development. Eur. J. Nuc. Med. Mol. Imaging 33, 857–861 (2006).

    Article  Google Scholar 

  6. Cerussi, A. E. et al. Diffuse optical spectroscopic imaging correlates with final pathological response in breast cancer adjuvant chemotherapy. Philos. Transact. A Math. Phys. Eng. Sci. 369, 4512–4530 (2011).

    Article  Google Scholar 

  7. Vesselle, H. et al. In vivo validation of 3'deoxy-3'-[(18)F]fluorothymidine ([(18)F]FLT) as a proliferation imaging tracer in humans: correlation of [(18)F]FLT uptake by positron emission tomography with Ki-67 immunohistochemistry and flow cytometry in human lung tumors. Clin. Cancer Res. 8, 3315–3323 (2002).

    CAS  PubMed  Google Scholar 

  8. Dancey, J. E. et al. Guidelines for the development and incorporation of biomarker studies in early clinical trials of novel agents. Clin. Cancer Res. 16, 1745–1755 (2010).

    Article  CAS  PubMed  Google Scholar 

  9. US National Library of Medicine. ClinicalTrials.gov [online], (2011).

  10. US National Library of Medicine. ClinicalTrials.gov [online], (2012).

  11. US National Library of Medicine. ClinicalTrials.gov [online], (2012).

  12. US National Library of Medicine. ClinicalTrials.gov [online], (2012).

  13. US National Library of Medicine. ClinicalTrials.gov [online], (2012).

  14. US National Library of Medicine. ClinicalTrials.gov [online], (2011).

  15. US National Library of Medicine. ClinicalTrials.gov [online], (2012).

  16. Sargent, D. J. et al. Validation of novel imaging methodologies for use as cancer clinical trial end-points. Eur. J. Cancer 45, 290–299 (2008).

    Article  PubMed  PubMed Central  Google Scholar 

  17. Shankar, L. K. et al. Considerations for the use of imaging tools for phase II treatment trials in oncology. Clin. Cancer Res. 15, 1891–1897 (2009).

    Article  CAS  PubMed  Google Scholar 

  18. Nunn, A. Imaging biomarkers, an industry perspective. J. Nucl. Med. 49, 28N–32N (2008).

    PubMed  Google Scholar 

  19. US Department of Health & Human Services. NIH Research Project Grant Program (R01) [online], (2012).

  20. US Department of Health & Human Services. NIH Exploratory/Developmental Research Grant Award (R21) [online], (2012).

  21. Jansen, J. F. et al. Noninvasive assessment of tumor microenvironment using dynamic contrast-enhanced magnetic resonance imaging and 18F-fluoromisonidazole positron emission tomography imaging in neck nodal metastases. Int. J. Radiat. Oncol. Biol. Phys. 77, 1403–1410 (2010).

    Article  PubMed  Google Scholar 

  22. Juhász, C. et al. Tryptophan metabolism in breast cancers: molecular imaging and immunohistochemistry studies. Nucl. Med. Biol. 39, 926–932 (2012).

    Article  PubMed  PubMed Central  Google Scholar 

  23. US Department of Health & Human Services. Quick-Trials for Imaging and Image-Guided Interventions: Exploratory Grants (R21) [online]

  24. US Department of Health & Human Services. Quick-Trials for Imaging and Image-Guided Interventions: Exploratory Grants (R21) [online]

  25. Boles Ponto, L. L. et al. Stability of 3'-deoxy-3'-[18F]fluorothymidine standardized uptake values in head and neck cancer over time. Cancer Biother. Radiopharm. 25, 361–363 (2010).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  26. Breshears, J. D. et al. Mapping sensorimotor cortex with slow cortical potential resting-state networks while awake and under anesthesia. Neurosurgery 71, 305–316 (2012).

    Article  PubMed  Google Scholar 

  27. Wali, R. K. et al. Topical polyethylene glycol as a novel chemopreventive agent for oral cancer via targeting of epidermal growth factor response. PLoS One 7, e38047 (2012).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  28. US Department of Health & Human Services. Early Phase Clinical Trials in Imaging and Image-Guided Interventions (R21) [online]

  29. National Cancer Institute. Translational Research Program (TRP) [online]

  30. National Cancer Institute. Cancer Imaging Program: Phase I/II Trials [online]

  31. Spence, A. M. et al. NCI-sponsored trial for the evaluation of safety and preliminary efficacy of 3'-deoxy-3'-[(18)F]fluorothymidine (FLT) as a marker of proliferation in patients with recurrent gliomas: preliminary efficacy studies. Mol. Imaging Biol. 11, 343–355 (2009).

    Article  PubMed  PubMed Central  Google Scholar 

  32. US National Library of Medicine. ClinicalTrials.gov [online], (2011).

  33. US National Library of Medicine. ClinicalTrials.gov [online], (2006).

  34. US National Library of Medicine. ClinicalTrials.gov [online], (2010).

  35. National Cancer Institute. Cancer Therapy Evaluation Program: Initiatives/Collaborations [online], (2012).

  36. National Cancer Institute. Cancer Imaging Program: Cancer Tracer Synthesis Resources [online]

  37. American College of Radiology Imaging Network. ACRIN's History [online]

  38. American College of Radiology Imaging Network [online], (2012).

  39. National Cancer Institute. Transforming the NCI Clinical Trials Enterprise [online]

  40. National Cancer Institute. Biomarker, Imaging and Quality of Life Studies Funding Program (BIQSFP) [online]

  41. US National Library of Medicine. ClinicalTrials.gov [online], (2011).

  42. Shankar, L. K. Standardization of PET imaging in clinical trials. PET Clinics 3, 1–4 (2008).

    Article  PubMed  Google Scholar 

  43. Shankar, L. K. et al. Consensus recommendations for the use of 18F-FDG PET as an indicator of therapeutic response in patients in National Cancer Institute trials. J. Nucl. Med. 47, 1059–1066 (2006).

    CAS  PubMed  Google Scholar 

  44. American College of Radiology Imaging Network. NCI Centers of Quantitative Imaging Excellence [online], (2012).

  45. Trimble, E. L. et al. Improving cancer outcomes through international collaboration in academic cancer treatment trials. J. Clin. Oncol. 27, 5109–5114 (2009).

    Article  PubMed  PubMed Central  Google Scholar 

  46. Eisenhauer, E. A. et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur. J. Cancer 45, 228–247 (2009).

    Article  CAS  PubMed  Google Scholar 

  47. Ford, R. et al. Lessons learned from independent central review. Eur. J. Cancer 45, 268–274 (2009).

    Article  CAS  PubMed  Google Scholar 

  48. Dancey, J. E. et al. Recommendations for the assessment of progression in randomised cancer treatment trials. Eur. J. Cancer 45, 281–289 (2009).

    Article  CAS  PubMed  Google Scholar 

  49. Schwartz, L. H. et al. Evaluation of lymph nodes with RECIST 1.1. Eur. J. Cancer. 45, 261–267 (2009).

    Article  CAS  PubMed  Google Scholar 

  50. Radiological Society of North America. Quantitative Imaging Biomarkers Alliance [online], (2012).

  51. Clinical Trials Network [online], (2012).

  52. US National Library of Medicine. ClinicalTrials.gov [online], (2012).

  53. Spence, A. M. et al. NCI-sponsored trial for the evaluation of safety and preliminary efficacy of FLT as a marker of proliferation in patients with recurrent gliomas: safety studies. Mol. Imaging Bio. 10, 271–280 (2008).

    Article  Google Scholar 

  54. US National Library of Medicine. ClinicalTrials.gov [online], (2011).

  55. Harisinghani, M., Ross, R. W., Guimaraes, A. R. & Weissleder, R. Utility of a new bolus-injectable nanoparticle for clinical cancer staging. Neoplasia 9, 1160–1165 (2007).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  56. US National Library of Medicine. ClinicalTrials.gov [online], (2011).

  57. US National Library of Medicine. ClinicalTrials.gov [online], (2011).

  58. US National Library of Medicine. ClinicalTrials.gov [online], (2012).

  59. US National Library of Medicine. ClinicalTrials.gov [online], (2012).

  60. US National Library of Medicine. ClinicalTrials.gov [online], (2012).

  61. US National Library of Medicine. ClinicalTrials.gov [online], (2012).

  62. Batchelor, T. T. et al. Phase II study of cediranib, an oral pan-vascular endothelial growth factor receptor tyrosine kinase inhibitor, in patients with recurrent glioblastoma. J. Clin. Oncol. 28, 2817–2823 (2010).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  63. Gerstner, E. R. et al. Infiltrative patterns of glioblastoma spread detected via diffusion MRI after treatment with cediranib. Neuro. Oncol. 12, 466–472 (2010).

    CAS  PubMed  PubMed Central  Google Scholar 

  64. US National Library of Medicine. ClinicalTrials.gov [online], (2011).

  65. US National Library of Medicine. ClinicalTrials.gov [online], (2012).

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Authors and Affiliations

  1. National Cancer Institute, Cancer Imaging Program, Chief Diagnostic Imaging Branch, 6130 Executive Boulevard, MSC7412, Bethesda, 20892 7412, MD, USA

    Lalitha K. Shankar

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Shankar, L. The clinical evaluation of novel imaging methods for cancer management. Nat Rev Clin Oncol 9, 738–744 (2012). https://doi.org/10.1038/nrclinonc.2012.186

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