Our department

With our department’s highest class of facility and experience, we utilize positron emission tomography (PET) to elucidate disease pathogenesis and develop new drugs.

Tomohiko Yamane, M.D., Ph.D., FANMB
Director of Molecular Imaging Research,
Center for Clinical Research and Innovation,
Kobe City Medical Center General Hospital

The Kobe City Medical Center General Hospital’s Department of Molecular Imaging pioneers PET clinical trials and related research with the highest class of technology and experience.

The term “molecular imaging” refers to the visualization of cell- or molecular-level activity in vivo. Our Department of Molecular Imaging Research works to elucidate the pathophysiology of diseases and develop new drugs using a diagnostic modality called “PET,” which allows the visualization of biological function.

The main objectives of our department, with respect to PET, are to manufacture investigational drugs, perform clinical trials and research, develop imaging/analysis methods, and produce quality controls. We have been conducting PET clinical trials since 2008, and we established a new hot lab that complies with good manufacturing practice (GMP) to produce investigational new drugs in 2011*1. These achievements and infrastructures are highly evaluated, and we have been entrusted with analyzing various PET investigational drugs and conducting PET clinical trials by domestic and foreign pharmaceutical companies.

In addition, as a public municipal hospital, we strive to treat our patients with strategies based on the latest research findings obtained through rigorous clinical studies. Therefore, we will continue to improve our knowledge of drug discovery, imaging, and quality control that we have cultivated to date to provide safe and highly effective diagnostic technology using PET and contribute to the progress of medical science.

*1 This was implemented in the Institute of Biomedical Research and Innovation, a former institute to which our department belonged. It was then transferred and integrated into Kobe City Medical Center General Hospital in November 2017.

PET drug manufacturing

Japan’s leading GMP system for PET investigational drugs

Our department started conducting PET clinical trials in 2008 and established a new hot lab complying with GMP for the development of investigational new drugs in 2011*1. These achievements and infrastructures are highly evaluated, and domestic and foreign pharmaceutical companies have commissioned us to manufacture various PET investigational drugs. These manufactured drugs are then used within our facility or transported to nearby medical institutions for PET clinical trials.

Our department has a self-shielded cyclotron and two GMP-compliant hot lab areas for PET drug production (one for new investigational drugs and the other for research). The production of PET drugs for clinical trials, including PET diagnostic drug trials and therapeutic drug trials that use PET as a biomarker, requires quality control, quality assurance, and good hygiene practices in line with global standards. As only a few facilities can fulfill these requirements in Japan, we are proud to provide a high-quality PET site for such clinical trials.

We are also engaged in manufacturing numerous PET drugs for studies other than clinical trials. Furthermore, we are developing new methods for the synthesis of PET drugs.

The manufacturing of PET investigational new drugs is handled by experts in PET drug manufacturing and management, who are working in collaboration with a partner company. Utilizing our experience, we advise client companies on drug manufacturing, compliance with Japanese laws and regulations, and preparation of relevant documents.

*1 This was implemented in the Institute of Biomedical Research and Innovation, a former institute to which our department belonged. It was then transferred and integrated into Kobe City Medical Center General Hospital in November 2017.

  • Iimori H, Hashizume Y, Sasaki M, et al. First automatic radiosynthesis of 11C labeled Telmisartan using a multipurpose synthesizer for clinical research use. Ann Nucl Med. 2011;25:333-337.

PET clinical trials

Our experienced staff members handle all types of PET clinical trials

PET clinical trials utilize radioactive drugs whose radioactivity decays over time. Unlike other general pharmaceutical trials, PET trials include special methods for handling subjects, image acquisition, and image processing. In our department, PET clinical trials are fully managed by our experienced staff comprising physicians, radiological technologists, nurses, and clinical research coordinators.

Our hospital has three PET/CT cameras. One of them is used exclusively for clinical trials and research, allowing us to respond flexibly to clinical trial schedules. Additionally, since our imaging and manufacturing facilities are integrated, we can also handle PET clinical trials using nuclides with 11C, in addition to 18F.

In addition to conducting phase I clinical trials of amyloid and tau PET tracers, the Department of Molecular Imaging Research has been actively involved in conducting PET studies of these tracers in the clinical trials for therapeutic agents of Alzheimer’s disease.

  • Nakano M, Nakamura T, Takita Y, et al. Radiation dosimetry and pharmacokinetics of florbetapir (18F) in Japanese subjects. Ann Nucl Med. 2019;33:639-645.
  • Miki T, Shimada H, Kim JS, et al. Brain uptake and safety of Flutemetamol F 18 injection in Japanese subjects with probable Alzheimer’s disease, subjects with amnestic mild cognitive impairment and healthy volunteers. Ann Nucl Med. 2017;31:260-272.
  • Senda M, Yamamoto Y, Sasaki M, et al. An exploratory efficacy study of the amyloid imaging agent [18F]flutemetamol in Japanese Subjects. Ann Nucl Med. 2015;29:391-399.
  • Senda M, Brooks DJ, Farrar G, et al. The clinical safety, biodistribution and internal radiation dosimetry of flutemetamol (18F) injection in healthy Japanese adult volunteers. Ann Nucl Med.2015;29:627-635.
  • Senda M, Sasaki M, Yamane T, et al. Ethnic comparison of pharmacokinetics of 18F-florbetaben, a PET tracer for beta-amyloid imaging, in healthy Caucasian and Japanese subjects. Eur J Nucl Med Mol Imaging. 2015;42:89-96.

PET clinical research

Accepting PET research from other institutes

In addition to clinical trials, we are actively engaged in PET clinical research. We manufacture PET drugs, including unapproved drugs, in our hospital and conduct clinical research for elucidating disease pathophysiology and drug clinical efficacy. The target diseases in our PET research include Alzheimer’s disease, Parkinson’s disease, and various malignant tumors. Aside from collaborating with each clinical department of Kobe City Medical Center General Hospital, we also accept patients from other hospitals, such as Kobe University Hospital. Furthermore, in collaboration with RIKEN, we have conducted first-in-human studies on novel PET radiopharmaceuticals and participated in the J-ADNI and AMED preclinical projects, nationwide projects on Alzheimer’s disease.

We also accept requests for PET imaging and collaborations for research purposes. If you wish to conduct clinical research using PET, but your institution does not have the facilities or support PET clinical research, please feel free to contact us.

  • Senda M, Ishii K, Ito K, et al. A Japanese multicenter study on PET and other biomarkers for subjects with potential preclinical and prodromal Alzheimer’s disease. J Prev Alzheimers Dis. 8;495-502:2021.
  • Watanabe Y, Mawatari A, Aita K, et al. PET imaging of 11C-labeled thiamine tetrahydrofurfuryl disulfide, vitamin B1 derivative: First-in-human study. Biochem Biophys Res Commun. 2021;555:7-12.
  • Akamatsu G, Ohnishi A, Aita K, et al. A revisit to quantitative PET with 18F-FDOPA of high specific activity using a high-resolution condition in view of application to regenerative therapy. Ann Nucl Med. 2017;31:163-171.
  • Ohnishi A, Senda M, Yamane T, et al. Exploratory human PET study of the effectiveness of 11C-ketoprofen methyl ester, a potential biomarker of neuroinflammatory processes in Alzheimer’s disease. Nucl Med Biol. 2016;43:438-444.
  • Ohnishi A, Senda M, Yamane T, et al. Human whole-body biodistribution and dosimetry of a new PET tracer, [11C]ketoprofen methyl ester, for imagings of neuroinflammation. Nucl Med Biol. 2014;41:594-599.
  • Yamane T, Takaoka A, Kita M, Imai Y, Senda M. 18F-FLT PET performs better than 18F-FDG PET in differentiating malignant uterine corpus tumors from benign leiomyoma. Ann Nucl Med. 2012;26:478-484.
  • Maeda K, Ohnishi A, Sasaki M, et al. Quantitative investigation of hepatobiliary transport of [11C]telmisartan in humans by PET imaging. Drug Metab Pharmacokinet. 2019;34:293-299.
  • Shimizu K, Takashima T, Yamane T, et al. Whole-body distribution and radiation dosimetry of [11C]telmisartan as a biomarker for hepatic organic anion transporting polypeptide (OATP) 1B3. Nucl Med Biol. 2012;39:847-853.
  • Kikuchi M, Yamane T, Shinohara S, et al. 18F-fluoromisonidazole positron emission tomography before treatment is a predictor of radiotherapy outcome and survival prognosis in patients with head and neck squamous cell carcinoma. Ann Nucl Med. 2011;25:625-633.
  • Yamane T, Kikuchi M, Shinohara S, Senda M. Reduction of [18F]fluoromisonidazole uptake after neoadjuvant chemotherapy for head and neck squamous cell carcinoma. Mol Imaging Biol. 2011;13:227-231.
  • Yamane T, Sakamoto S, Senda M. Clinical impact of 11C-methionine PET on expected management of patients with brain neoplasm. Eur J Nucl Med Mol Imaging. 2010;37:685-690.
  • Senda M, Kubo N, Adachi K, et al. Cerebral histamine H1 receptor binding potential measured with PET under a test dose of olopatadine, an antihistamine, is reduced after repeated administration of olopatadine. J Nucl Med. 2009;50:887-892.


High quality PET images and precise quantification through professional quality control

Image quality, quantitative values, and diagnostic performance in PET imaging and clinical studies are affected by various elements, including the imaging device (PET camera), imaging method, and image evaluation and analysis. Therefore, standardization is necessary through appropriate quality control to establish PET as a reliable and universal examination tool. Moreover, additional information or highly accurate data can be obtained by devising new methods for acquisition or image analysis. Thus, we also aim to develop such methodologies.

PET-cores in Multicenter Clinical Studies

In multicenter PET clinical studies, PET cameras, acquisition methods, and the experience and system of each facility inevitably differ. Therefore, standardization and data quality control are necessary to build a reliable multicenter PET database to promote PET as an imaging biomarker. We have collaborated with the J-ADNI and other national multicenter clinical research projects on Alzheimer’s disease as the “PET-core” in these endeavors by standardizing PET imaging and performing data quality control across the country. As a result, the Japanese Society of Nuclear Medicine later adopted the outcomes of the PET-core as the standard protocol for FDG and amyloid PET in the brain and the certification system for PET imaging facilities. Furthermore, these methods have been disseminated beyond the project, helping improve the quality of PET facilities nationwide.

  • Senda M. Standardization of PET imaging and site qualification program by JSNM: collaboration with EANM/EARL. Ann Nucl Med. 2020;34:873-874.
  • Akamatsu G, Ikari Y, Ohnishi A, et al. Voxel-based statistical analysis and quantification of amyloid PET in the Japanese Alzheimer’s disease neuroimaging initiative (J-ADNI) multi-center study. EJNMMI Res. 2019;9:91.
  • Akamatsu G, Nishio T, Adachi K, Ikari Y, Senda M. Whole-body biodistribution and the influence of body activity on brain kinetic analysis of the 11C-PiB PET scan. Radiol Phys Technol. 2017;10:464-474.
  • Yamane T, Ishii K, Sakata M, et al. Inter-rater variability of visual interpretation and comparison with quantitative evaluation of 11C-PiB PET amyloid images of the Japanese Alzheimer’s Disease Neuroimaging Initiative (J-ADNI) multicenter study. Eur J Nucl Med Mol Imaging. 2017;44:850-857.
  • Akamatsu G, Ikari Y, Nishio T, et al. Optimization of image reconstruction conditions with phantoms for brain FDG and amyloid PET imaging. Ann Nucl Med. 2016;30:18-28.
  • Ikari Y, Akamatsu G, Nishio T, et al. Phantom criteria for qualification of brain FDG and amyloid PET across different cameras. EJNMMI Phys. 2016;3:23.
  • Yamane T, Ikari Y, Nishio T, Ishii K, Ishii K, Kato T, et al. Visual-statistical interpretation of 18F-FDG-PET images for characteristic Alzheimer patterns in a multicenter study: inter-rater concordance and relationship to automated quantitative evaluation. AJNR Am J Neuroradiol. 2014;35:244-9.
  • Ikari Y, Nishio T, Makishi Y, et al. Head motion evaluation and correction for PET scans with 18F-FDG in the Japanese Alzheimer’s disease neuroimaging initiative (J-ADNI) multi-center study. Ann Nucl Med. 2012;26:535-544.


Education M.D. Kyoto University
Ph.D. Kyoto University
Certifications Diagnostic radiology (Japanese Radiological Society)
Nuclear medicine (Japanese Society of Nuclear Medicine)

Education M.D. Nara Medical University 
Certifications  Nuclear medicine (Japanese Society of Nuclear Medicine)
Diagnostic radiology (Japanese Radiological Society)
Fellow of Asian nuclear medicine board (Asian Nuclear Medicine Board)
Publications https://researchmap.jp/tomohiko_yamane/published_papers

Part-time M.D. Yasuji Yamamoto, M.D.,Ph.D.

Part-time M.D. Akihito Ohnishi, M.D.,Ph.D.