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Use of Molecular Imaging in Clinical Drug Development: a Systematic Review

  • Hyeomin Son
  • Kyungho Jang
  • Heechan Lee
  • Sang Eun Kim
  • Keon Wook Kang
  • Howard LeeEmail author
Original Article
  • 25 Downloads

Abstract

Background

Molecular imaging such as positron emission tomography (PET) and single-photon emission computed tomography (SPECT) can provide the crucial pharmacokinetic-pharmacodynamic information of a drug non-invasively at an early stage of clinical drug development. Nevertheless, not much has been known how molecular imaging has been actually used in drug development studies.

Methods

We searched PubMed using such keywords as molecular imaging, PET, SPECT, drug development, and new drug, or any combination of those to select papers in English, published from January 1, 1990, to December 31, 2015. The information about the publication year, therapeutic area of a drug candidate, drug development phase, and imaging modality and utility of imaging were extracted.

Results

Of 10,264 papers initially screened, 208 papers met the eligibility criteria. The more recent the publication year, the bigger the number of papers, particularly since 2010. The two major therapeutic areas using molecular imaging to develop drugs were oncology (47.6%) and the central nervous system (CNS, 36.5%), in which efficacy (63.5%) and proof-of-concept through either receptor occupancy (RO) or other than RO (29.7%), respectively, were the primary utility of molecular imaging. PET was used 4.7 times more frequently than SPECT. Molecular imaging was most frequently used in phase I clinical trials (40.8%), whereas it was employed rarely in phase 0 or exploratory IND studies (1.4%).

Conclusions

The present study confirmed the trend that molecular imaging has been more actively employed in recent clinical drug development studies although its adoption was rather slow and rare in phase 0 studies.

Keywords

Molecular imaging Drug development PET SPECT 

Notes

Funding

This research was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HI14C1072).

Compliance with Ethical Standards

Conflicts of Interest

Hyeomin Son, Kyungho Jang, Heechan Lee, Sang Eun Kim, Keon Wook Kang, and Howard Lee certify that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript.

Supplementary material

13139_2019_593_MOESM1_ESM.docx (27 kb)
ESM 1 (DOCX 27 kb)

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Copyright information

© Korean Society of Nuclear Medicine 2019

Authors and Affiliations

  • Hyeomin Son
    • 1
  • Kyungho Jang
    • 2
  • Heechan Lee
    • 1
  • Sang Eun Kim
    • 3
    • 4
  • Keon Wook Kang
    • 5
  • Howard Lee
    • 1
    • 3
    Email author
  1. 1.Department of Clinical Pharmacology and TherapeuticsSeoul National University College of Medicine and HospitalSeoulRepublic of Korea
  2. 2.Center for Clinical Pharmacology, Biomedical Research InstituteChonbuk National University HospitalJeonjuRepublic of Korea
  3. 3.Department of Transdisciplinary Studies, Graduate School of Convergence Science and TechnologySeoul National UniversitySeoulRepublic of Korea
  4. 4.Department of Nuclear MedicineSeoul National University College of Medicine and Seoul National University Bundang HospitalSeongnamRepublic of Korea
  5. 5.Department of Nuclear Medicine & Cancer Research InstituteSeoul National University College of MedicineSeoulRepublic of Korea

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