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Additional effects of FDG-PET to thin-section CT for the differential diagnosis of lung nodules: a Japanese multicenter clinical study

Annals of Nuclear Medicine volume 25, pages 787–795 (2011)Cite this article

Abstract

Objective

This study was a controlled multicenter clinical study on patients with peripheral lung nodules to verify the improvement in the diagnostic ability of FDG-PET when used in combination with thin-section CT (TS-CT).

Methods

Patients with peripheral lung nodules (long maximal diameter: 10–30 mm) detected using CT were examined using TS-CT and FDG-PET for the differential diagnosis of benign or malignant lesions. The primary endpoint was the specificity of the results using a combination of TS-CT and FDG-PET, compared with the results for TS-CT alone. Images were interpreted by investigators at each institution. Blind readings were also performed by an independent image interpretation committee. The gold standard was a pathological diagnosis determined using a surgical or biopsy specimen obtained after PET; and the patients in whom a pathological diagnosis could not be obtained were diagnosed based on a follow-up TS-CT performed more than 6 months later. Adverse reactions to FDG were also evaluated.

Results

The blind reading results for 82 lesions in 81 subjects eligible for analysis among the 90 subjects included in the study showed a specificity of 91.2% (31/34) (95% CI: 76.3–98.1) for TS-CT + PET, compared with a specificity of 67.6% (23/34) (95% CI: 49.5–82.6) for TS-CT alone. The specificity was significantly improved by the addition of the PET findings (p < 0.05). The sensitivity improved from 89.6% (43/48) for TS-CT to 91.7% (44/48) for TS-CT + PET; the addition of PET increased the level of confidence in the diagnosis, but the difference was not significant. The results reported by the institutional investigators were not significantly different. No serious adverse reactions occurred, although two of the 90 subjects exhibited mild adverse reactions.

Conclusions

The addition of FDG-PET to TS-CT for the differential diagnosis of benign or malignant peripheral lung nodules resulted in a significant improvement in specificity. Although a definitive diagnosis of lung nodules requires a histopathological or cytological examination, when combined with TS-CT, FDG-PET can provide additional diagnostic information and improve the specificity.

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Acknowledgments

We thank the patients, clinical research coordinators, radiologists and subinvestigators for their participation in this study. Also we thank Ms. Akiko Shibuya, for her contribution to prepare manuscript. This study was sponsored by Nihon Medi-Physics co., Ltd, Tokyo, Japan.

Conflict of interest

Dr. Shiomi currently has the conflict of interest with the company while other authors do not.

Author information

Affiliations

  1. Division of Nuclear Medicine, Department of Radiology, National Center for Global Health and Medicine, 1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan

    Kazuo Kubota

  2. Division of Nuclear Medicine, Department of Radiology, School of Medicine, Keio University, Tokyo, Japan

    Koji Murakami

  3. Department of Radiology, Graduate School of Medicine, Yokohama City University, Yokohama, Japan

    Tomio Inoue

  4. Molecular Imaging Center, National Institute of Radiological Sciences, Chiba, Japan

    Tsuneo Saga

  5. Department of Nuclear Medicine, Osaka City University Graduate School of Medicine, Osaka, Japan

    Susumu Shiomi

Authors
  1. Kazuo Kubota
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  2. Koji Murakami
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  3. Tomio Inoue
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  4. Tsuneo Saga
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  5. Susumu Shiomi
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Corresponding author

Correspondence to Kazuo Kubota.

Appendix:

Appendix:

Institutions of the Study: National Cancer Center Hospital East, Yokohama City University Hospital, Kyoto University Hospital, Osaka City University Hospital.

Members of the Study Organization were as follows:

Independent Image Interpretation Committee: E. Tsukamoto, T. Nambu; Hokkaido University Hospital. M. Sasaki, S. Sakai; Kyushu University Hospital.

Independent Entry Criteria Judging Committee: H. Itoh; Fukui Medical University Hospital.

Protocol Exploratory Committee: S. Kudo; Osaka City University Hospital. F. Tanaka; Kyoto University Hospital. K.Murakami; National Cancer Center Hospital East.

Investigators: H. Ikeda, K. Murakami; National Cancer Center Hospital East., J. Konishi, T. Saga; Kyoto University Hospital., H. Ochi, S. Shiomi; Osaka City University Hospital., T. Inoue; Yokohama City University Hospital.

Coordinating Investigator: K.Kubota; National Center for Global Health and Medicine.

Medical consultants of the sponsor: K. Torizuka; Professor Emeritus, Kyoto University, Y.Takagi; Department of Clinical Pathology, and Office of Medical Education, Showa University.

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Kubota, K., Murakami, K., Inoue, T. et al. Additional effects of FDG-PET to thin-section CT for the differential diagnosis of lung nodules: a Japanese multicenter clinical study. Ann Nucl Med 25, 787–795 (2011). https://doi.org/10.1007/s12149-011-0528-5

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  • DOI: https://doi.org/10.1007/s12149-011-0528-5

Keywords

  • Solitary pulmonary nodule
  • FDG-PET
  • CT
  • Multicenter study