title: Copper-64 trastuzumab PET imaging: a reproducibility study.
abstract: BACKGROUND
  The current study aims to assess the safety, pharmacokinetics, feasibility, and reproducibility of immunoPET imaging with copper-64 (64Cu) trastuzumab.
  
  
  METHODS
  An IV injection of 296-370 MBq/5 mg 64Cu-trastuzumab was administered between 1 to 4 hours after routine trastuzumab treatment. Whole-body PET scans were performed immediately post-injection and at 24 hours post-injection. Serial pharmacokinetics were performed. Of 11 patients (median age of 52; range of 31-61), 8 underwent a repeat study with 64Cu-trastuzumab to assess image and pharmacokinetic reproducibility. Patients were monitored for toxicity.
  
  
  RESULTS
  Patients experienced no allergic reactions or significant adverse effects from 64Cu-trastuzumab. Eight patients successfully completed a repeat 64Cu-trastuzumab study, with acceptable reproducibility of both the biodistribution and pharmacokinetic clearance. Study 1 versus study 2 showed similar serum concentration post-injection (mean 42.4±7.8 %ID/L vs. 44.7±12.6 %ID/L) and similar T1/2 (single exponential 46.1 vs. 44.2 hours), P>0.5. The volume of distribution (median 2.50 L) was in the range reported for trastuzumab and close to the estimated plasma volume of 2.60 L. Of 11 patients, two had 64Cu-trastuzumab localization corresponding to known tumor sites - one in liver and one in breast.
  
  
  CONCLUSIONS
  Preliminary results suggest that scanning with 64Cu-trastuzumab is feasible, safe, and reproducible. Tumor uptake of 64Cu-trastuzumab was observed, but tumor detection exhibited low sensitivity in this study in which imaging was performed in the presence of trastuzumab therapy.
authors.affiliation: Molecular Imaging and Therapy Service, Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA - carrasj1@mskcc.org.|Center for Radioimmunotherapy and Theranostics, Ludwig Center, Memorial Sloan Kettering Cancer Center, New York, NY, USA - carrasj1@mskcc.org.
authors.forename: Jorge A
authors.initials: JA
authors.lastname: Carrasquillo
authors.affiliation: Breast Cancer Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.|Department of Oncology, Beaumont Hospital, Dublin, Ireland.
authors.forename: Patrick G
authors.initials: PG
authors.lastname: Morris
authors.affiliation: Department of Medical Physics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
authors.forename: John L
authors.initials: JL
authors.lastname: Humm
authors.affiliation: Molecular Imaging and Therapy Service, Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.|Department of Psychiatry, Stony Brook University, Stony Brook, NY, USA.
authors.forename: Peter M
authors.initials: PM
authors.lastname: Smith-Jones
authors.affiliation: Molecular Imaging and Therapy Service, Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
authors.forename: Volkan
authors.initials: V
authors.lastname: Beylergil
authors.affiliation: Molecular Imaging and Therapy Service, Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.|Peter MacCallum Cancer Center, Melbourne, Australia.
authors.forename: Timothy
authors.initials: T
authors.lastname: Akhurst
authors.affiliation: Department of Medical Physics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
authors.forename: Joseph A
authors.initials: JA
authors.lastname: O'donoghue
authors.affiliation: Molecular Imaging and Therapy Service, Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
authors.forename: Shutian
authors.initials: S
authors.lastname: Ruan
authors.affiliation: Breast Cancer Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
authors.forename: Shanu
authors.initials: S
authors.lastname: Modi
authors.affiliation: Breast Cancer Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
authors.forename: Clifford A
authors.initials: CA
authors.lastname: Hudis
authors.affiliation: Molecular Imaging and Therapy Service, Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.|Center for Radioimmunotherapy and Theranostics, Ludwig Center, Memorial Sloan Kettering Cancer Center, New York, NY, USA.|Sloan Kettering Institute, New York, NY, USA.
authors.forename: Steven M
authors.initials: SM
authors.lastname: Larson
mesh_terms: D000328:Adult; D001943:Breast Neoplasms / Q000000981:diagnostic imaging* / Q000378:metabolism; D003301:Copper Radioisotopes; D015972:Gene Expression Regulation, Neoplastic; D006801:Humans; D008875:Middle Aged; D049268:Positron-Emission Tomography / Q000379:methods*; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D015203:Reproducibility of Results; D014018:Tissue Distribution; D000068878:Trastuzumab / Q000493:pharmacokinetics
chemical_list: D003301:Copper Radioisotopes; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C000615411:Copper-64; C508053:ERBB2 protein, human