Rapid diagnostic imaging of acute, nonclassic appendicitis by leukoscintigraphy with sulesomab, a technetium 99m-labeled antigranulocyte antibody Fab' fragment

Bruce Barron, Charles Hanna, Anthony M. Passalaqua, Lamk Lamki, William A. Wegener, David M. Goldenberg

Research output: Contribution to journalArticle

47 Citations (Scopus)

Abstract

Background. The purpose of this study was to evaluate the safety and efficacy of a technetium 99m-labeled antigranulocyte antibody Fab' fragment (sulesomab) as a diagnostic imaging agent in patients with suspected acute, nonclassic appendicitis. Methods. This prospective multicenter trial involved 141 children and adults with suspected acute, nonclassic appendicitis. The investigators interpreted planar images acquired 15 to 30 minutes and 1, 2, and 4 hours after injection and also by single-photon emission computed tomography (SPECT). The imaging results were confirmed surgically, whereas nonsurgical patients were considered as not having appendicitis (intent to treat). Results. Sulesomab had a sensitivity of 91% (29/32 patients) and a negative predictive rate of 97% for acute appendicitis. It detected additional abnormalities in 7 of 9 patients with other inflammatory abdominal disease and had a specificity of 92% (91/99 patients) and a positive predictive value of 80% for surgically confirmed right-lower-quadrant disease. In positive studies, 26% were identified by planar imaging at 15 to 30 minutes, 46% by 1 hour, 63% by 2 hours, and 71% by 4 hours; 29% required SPECT to detect the abnormality. Scanning time was 5 to 10 minutes per planar image and about 45 minutes for a SPECT study. Investigators found that sulesomab would have changed clinical management or reduced additional diagnostic studies in 64% of the patients. Adverse events were infrequent, minor, and self-limiting (9/141 patients, 6%). No human antimurine antibody response occurred in 48 evaluable patients. Conclusions. Sulesomab is safe, well-tolerated, and with no apparent immunogenicity. Focal inflammation or infection in the setting of suspected atypical appendicitis is rapidly and accurately detected. Management decisions incorporating sulesomab imaging potentially provide clear patient benefits, especially by correctly predicting surgery to be unnecessary in 97% of patients without acute appendicitis.

Original languageEnglish
Pages (from-to)288-296
Number of pages9
JournalSurgery
Volume125
Issue number3
Publication statusPublished - 1999

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Immunoglobulin Fragments
Immunoglobulin Fab Fragments
Technetium
Appendicitis
Diagnostic Imaging
Single-Photon Emission-Computed Tomography
Research Personnel
Sulesomab
Proxy
Multicenter Studies
Antibody Formation
Inflammation
Safety
Injections

ASJC Scopus subject areas

  • Surgery
  • Medicine(all)

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Rapid diagnostic imaging of acute, nonclassic appendicitis by leukoscintigraphy with sulesomab, a technetium 99m-labeled antigranulocyte antibody Fab' fragment. / Barron, Bruce; Hanna, Charles; Passalaqua, Anthony M.; Lamki, Lamk; Wegener, William A.; Goldenberg, David M.

In: Surgery, Vol. 125, No. 3, 1999, p. 288-296.

Research output: Contribution to journalArticle

Barron, Bruce ; Hanna, Charles ; Passalaqua, Anthony M. ; Lamki, Lamk ; Wegener, William A. ; Goldenberg, David M. / Rapid diagnostic imaging of acute, nonclassic appendicitis by leukoscintigraphy with sulesomab, a technetium 99m-labeled antigranulocyte antibody Fab' fragment. In: Surgery. 1999 ; Vol. 125, No. 3. pp. 288-296.
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abstract = "Background. The purpose of this study was to evaluate the safety and efficacy of a technetium 99m-labeled antigranulocyte antibody Fab' fragment (sulesomab) as a diagnostic imaging agent in patients with suspected acute, nonclassic appendicitis. Methods. This prospective multicenter trial involved 141 children and adults with suspected acute, nonclassic appendicitis. The investigators interpreted planar images acquired 15 to 30 minutes and 1, 2, and 4 hours after injection and also by single-photon emission computed tomography (SPECT). The imaging results were confirmed surgically, whereas nonsurgical patients were considered as not having appendicitis (intent to treat). Results. Sulesomab had a sensitivity of 91{\%} (29/32 patients) and a negative predictive rate of 97{\%} for acute appendicitis. It detected additional abnormalities in 7 of 9 patients with other inflammatory abdominal disease and had a specificity of 92{\%} (91/99 patients) and a positive predictive value of 80{\%} for surgically confirmed right-lower-quadrant disease. In positive studies, 26{\%} were identified by planar imaging at 15 to 30 minutes, 46{\%} by 1 hour, 63{\%} by 2 hours, and 71{\%} by 4 hours; 29{\%} required SPECT to detect the abnormality. Scanning time was 5 to 10 minutes per planar image and about 45 minutes for a SPECT study. Investigators found that sulesomab would have changed clinical management or reduced additional diagnostic studies in 64{\%} of the patients. Adverse events were infrequent, minor, and self-limiting (9/141 patients, 6{\%}). No human antimurine antibody response occurred in 48 evaluable patients. Conclusions. Sulesomab is safe, well-tolerated, and with no apparent immunogenicity. Focal inflammation or infection in the setting of suspected atypical appendicitis is rapidly and accurately detected. Management decisions incorporating sulesomab imaging potentially provide clear patient benefits, especially by correctly predicting surgery to be unnecessary in 97{\%} of patients without acute appendicitis.",
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AU - Wegener, William A.

AU - Goldenberg, David M.

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AB - Background. The purpose of this study was to evaluate the safety and efficacy of a technetium 99m-labeled antigranulocyte antibody Fab' fragment (sulesomab) as a diagnostic imaging agent in patients with suspected acute, nonclassic appendicitis. Methods. This prospective multicenter trial involved 141 children and adults with suspected acute, nonclassic appendicitis. The investigators interpreted planar images acquired 15 to 30 minutes and 1, 2, and 4 hours after injection and also by single-photon emission computed tomography (SPECT). The imaging results were confirmed surgically, whereas nonsurgical patients were considered as not having appendicitis (intent to treat). Results. Sulesomab had a sensitivity of 91% (29/32 patients) and a negative predictive rate of 97% for acute appendicitis. It detected additional abnormalities in 7 of 9 patients with other inflammatory abdominal disease and had a specificity of 92% (91/99 patients) and a positive predictive value of 80% for surgically confirmed right-lower-quadrant disease. In positive studies, 26% were identified by planar imaging at 15 to 30 minutes, 46% by 1 hour, 63% by 2 hours, and 71% by 4 hours; 29% required SPECT to detect the abnormality. Scanning time was 5 to 10 minutes per planar image and about 45 minutes for a SPECT study. Investigators found that sulesomab would have changed clinical management or reduced additional diagnostic studies in 64% of the patients. Adverse events were infrequent, minor, and self-limiting (9/141 patients, 6%). No human antimurine antibody response occurred in 48 evaluable patients. Conclusions. Sulesomab is safe, well-tolerated, and with no apparent immunogenicity. Focal inflammation or infection in the setting of suspected atypical appendicitis is rapidly and accurately detected. Management decisions incorporating sulesomab imaging potentially provide clear patient benefits, especially by correctly predicting surgery to be unnecessary in 97% of patients without acute appendicitis.

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