title: 64Cu-DOTA-trastuzumab PET imaging in patients with HER2-positive breast cancer.
abstract: The purpose of this study was to determine the safety, distribution, internal dosimetry, and initial human epidermal growth factor receptor 2 (HER2)-positive tumor images of (64)Cu-DOTA-trastuzumab in humans.
  
  
  METHODS
  PET was performed on 6 patients with primary or metastatic HER2-positive breast cancer at 1, 24, and 48 h after injection of approximately 130 MBq of the probe (64)Cu-DOTA-trastuzumab. Radioactivity data were collected from the blood, urine, and normal-tissue samples of these 6 patients, and the multiorgan biodistribution and internal dosimetry of the probe were evaluated. Safety data were collected for all the patients after the administration of (64)Cu-DOTA-trastuzumab and during the 1-wk follow-up period.
  
  
  RESULTS
  According to our results, the best timing for the assessment of (64)Cu-DOTA-trastuzumab uptake by the tumor was 48 h after injection. Radiation exposure during (64)Cu-DOTA-trastuzumab PET was equivalent to that during conventional (18)F-FDG PET. The radioactivity in the blood was high, but uptake of (64)Cu-DOTA-trastuzumab in normal tissues was low. In 2 patients, (64)Cu-DOTA-trastuzumab PET showed brain metastases, indicative of blood-brain barrier disruptions. In 3 patients, (64)Cu-DOTA-trastuzumab PET imaging also revealed primary breast tumors at the lesion sites initially identified by CT.
  
  
  CONCLUSIONS
  The findings of this study indicated that (64)Cu-DOTA-trastuzumab PET is feasible for the identification of HER2-positive lesions in patients with primary and metastatic breast cancer. The dosimetry and pharmacologic safety results were acceptable at the dose required for adequate PET imaging.
authors.affiliation: Department of Breast and Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Tamura
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Kurihara
authors.forename: Kan
authors.initials: K
authors.lastname: Yonemori
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Tsuda
authors.forename: Junko
authors.initials: J
authors.lastname: Suzuki
authors.forename: Yuzuru
authors.initials: Y
authors.lastname: Kono
authors.forename: Natsuki
authors.initials: N
authors.lastname: Honda
authors.forename: Makoto
authors.initials: M
authors.lastname: Kodaira
authors.forename: Harukaze
authors.initials: H
authors.lastname: Yamamoto
authors.forename: Mayu
authors.initials: M
authors.lastname: Yunokawa
authors.forename: Chikako
authors.initials: C
authors.lastname: Shimizu
authors.forename: Koki
authors.initials: K
authors.lastname: Hasegawa
authors.forename: Yousuke
authors.initials: Y
authors.lastname: Kanayama
authors.forename: Satoshi
authors.initials: S
authors.lastname: Nozaki
authors.forename: Takayuki
authors.initials: T
authors.lastname: Kinoshita
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Wada
authors.forename: Shusaku
authors.initials: S
authors.lastname: Tazawa
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Takahashi
authors.forename: Yasuyoshi
authors.initials: Y
authors.lastname: Watanabe
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Fujiwara
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects; D001943:Breast Neoplasms / Q000000981:diagnostic imaging* / Q000378:metabolism* / Q000473:pathology; D005240:Feasibility Studies; D006801:Humans; D007091:Image Processing, Computer-Assisted; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009942:Organometallic Compounds / Q000009:adverse effects; D049268:Positron-Emission Tomography / Q000009:adverse effects / Q000379:methods*; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D012449:Safety; D000068878:Trastuzumab
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D009942:Organometallic Compounds; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C546788:64Cu-DOTA-trastuzumab
keywords: 64Cu; HER2-positive breast cancer; PET; molecular imaging; trastuzumab