PT - JOURNAL ARTICLE AU - Tamura, Kenji AU - Kurihara, Hiroaki AU - Yonemori, Kan AU - Tsuda, Hitoshi AU - Suzuki, Junko AU - Kono, Yuzuru AU - Honda, Natsuki AU - Kodaira, Makoto AU - Yamamoto, Harukaze AU - Yunokawa, Mayu AU - Shimizu, Chikako AU - Hasegawa, Koki AU - Kanayama, Yousuke AU - Nozaki, Satoshi AU - Kinoshita, Takayuki AU - Wada, Yasuhiro AU - Tazawa, Shusaku AU - Takahashi, Kazuhiro AU - Watanabe, Yasuyoshi AU - Fujiwara, Yasuhiro TI - <sup>64</sup>Cu-DOTA-Trastuzumab PET Imaging in Patients with HER2-Positive Breast Cancer AID - 10.2967/jnumed.112.118612 DP - 2013 Nov 01 TA - Journal of Nuclear Medicine PG - 1869--1875 VI - 54 IP - 11 4099 - http://jnm.snmjournals.org/content/54/11/1869.short 4100 - http://jnm.snmjournals.org/content/54/11/1869.full SO - J Nucl Med2013 Nov 01; 54 AB - 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 64Cu-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 64Cu-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 64Cu-DOTA-trastuzumab and during the 1-wk follow-up period. Results: According to our results, the best timing for the assessment of 64Cu-DOTA-trastuzumab uptake by the tumor was 48 h after injection. Radiation exposure during 64Cu-DOTA-trastuzumab PET was equivalent to that during conventional 18F-FDG PET. The radioactivity in the blood was high, but uptake of 64Cu-DOTA-trastuzumab in normal tissues was low. In 2 patients, 64Cu-DOTA-trastuzumab PET showed brain metastases, indicative of blood–brain barrier disruptions. In 3 patients, 64Cu-DOTA-trastuzumab PET imaging also revealed primary breast tumors at the lesion sites initially identified by CT. Conclusion: The findings of this study indicated that 64Cu-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.