title: Use of Sulesomab, a radiolabeled antibody fragment, to detect osteomyelitis in diabetic patients with foot ulcers by leukoscintigraphy.
abstract: Diabetic patients suspected of having osteomyelitis secondary to foot ulcers underwent scintigraphic imaging with Sulesomab, an anti-granulocyte antibody Fab' fragment labeled with technetium-99m. Among 122 patients who had osteomyelitis confirmed or excluded by histopathologic and/or microbiologic techniques, Sulesomab had a 91% sensitivity, a 56% specificity, and an accuracy of 80%. One planar imaging session was usually sufficient for diagnosis, typically requiring 20-30 minutes of camera time 1-2 hours after injection. Compared with ex vivo autologous white blood cell (WBC) scans, Sulesomab performed comparably but with significantly greater sensitivity (92% vs. 79%; P < .05). Sulesomab results were more sensitive than radiography (90% vs. 62%; P < .05) and more specific than bone scans (50% vs. 21%; P < .05) and would have altered management plans in most patients. No related adverse events occurred, and there was no induction of human anti-mouse antibody. Sulesomab is an effective and rapid imaging agent that is diagnostically comparable or superior to WBC scans in this setting, with significant advantages in safety and ease of use.
authors.affiliation: Bay Pines Department of Veterans Affairs Medical Center, Florida 33744, USA. harwood.steven_j@bay-pines.va.gov
authors.forename: S J
authors.initials: SJ
authors.lastname: Harwood
authors.forename: S
authors.initials: S
authors.lastname: Valdivia
authors.forename: G L
authors.initials: GL
authors.lastname: Hung
authors.forename: R W
authors.initials: RW
authors.lastname: Quenzer
mesh_terms: D000911:Antibodies, Monoclonal / Q000009:adverse effects; D058846:Antibodies, Monoclonal, Murine-Derived; D017719:Diabetic Foot / Q000000981:diagnostic imaging*; D005260:Female; D006801:Humans; D007962:Leukocytes / Q000000981:diagnostic imaging*; D008297:Male; D008875:Middle Aged; D010019:Osteomyelitis / Q000000981:diagnostic imaging*; D011877:Radionuclide Imaging; D012680:Sensitivity and Specificity
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; C101172:Sulesomab