title: 99mTc-besilesomab (Scintimun) in peripheral osteomyelitis: comparison with 99mTc-labelled white blood cells.
abstract: OBJECTIVE
  The diagnosis of osteomyelitis is a challenge for diagnostic imaging. Nuclear medicine procedures including white blood cell imaging have been successfully used for the identification of bone infections. This multinational, phase III clinical study in 22 European centres was undertaken to compare anti-granulocyte imaging using the murine IgG antibody besilesomab (Scintimun) with (99m)Tc-labelled white blood cells in patients with peripheral osteomyelitis.
  
  
  METHODS
  A total of 119 patients with suspected osteomyelitis of the peripheral skeleton received (99m)Tc-besilesomab and (99m)Tc-hexamethylpropyleneamine oxime (HMPAO)-labelled white blood cells (WBCs) in random order 2-4 days apart. Planar images were acquired at 4 and 24 h after injection. All scintigraphic images were interpreted in an off-site blinded read by three experienced physicians specialized in nuclear medicine, followed by a fourth blinded reader for adjudication. In addition, clinical follow-up information was collected and a final diagnosis was provided by the investigators and an independent truth panel. Safety data including levels of human anti-mouse antibodies (HAMA) and vital signs were recorded.
  
  
  RESULTS
  The agreement in diagnosis across all three readers between Scintimun and (99m)Tc-HMPAO-labelled WBCs was 0.83 (lower limit of the 95% confidence interval 0.8). Using the final diagnosis of the local investigator as a reference, Scintimun had higher sensitivity than (99m)Tc-HMPAO-labelled WBCs (74.8 vs 59.0%) at slightly lower specificity (71.8 vs 79.5%, respectively). All parameters related to patient safety (laboratory data, vital signs) did not provide evidence of an elevated risk associated with the use of Scintimun except for two cases of transient hypotension. HAMA were detected in 16 of 116 patients after scan (13.8%).
  
  
  CONCLUSIONS
  Scintimun imaging is accurate, efficacious and safe in the diagnosis of peripheral bone infections and provides comparable information to (99m)Tc-HMPAO-labelled WBCs.
authors.affiliation: Pharmtrace klinische Entwicklung GmbH, Alt-Moabit 59-61, 10555 Berlin, Germany.
authors.forename: Wolf S
authors.initials: WS
authors.lastname: Richter
authors.forename: Velimir
authors.initials: V
authors.lastname: Ivancevic
authors.forename: Johannes
authors.initials: J
authors.lastname: Meller
authors.forename: Otto
authors.initials: O
authors.lastname: Lang
authors.forename: Dominique
authors.initials: D
authors.lastname: Le Guludec
authors.forename: István
authors.initials: I
authors.lastname: Szilvazi
authors.forename: Holger
authors.initials: H
authors.lastname: Amthauer
authors.forename: Florence
authors.initials: F
authors.lastname: Chossat
authors.forename: Amel
authors.initials: A
authors.lastname: Dahmane
authors.forename: Carsten
authors.initials: C
authors.lastname: Schwenke
authors.forename: Alberto
authors.initials: A
authors.lastname: Signore
mesh_terms: D000328:Adult; D000818:Animals; D002908:Chronic Disease; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000009:adverse effects; D007249:Inflammation / Q000000981:diagnostic imaging; D007962:Leukocytes / Q000000981:diagnostic imaging*; D051379:Mice; D008875:Middle Aged; D010019:Osteomyelitis / Q000097:blood* / Q000000981:diagnostic imaging*; D011877:Radionuclide Imaging; D012680:Sensitivity and Specificity; D019690:Technetium Tc 99m Exametazime / Q000009:adverse effects; D055986:Vital Signs
chemical_list: D007074:Immunoglobulin G; D019690:Technetium Tc 99m Exametazime