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Neutrophil-Specific ^99mTc-Labeled Anti-CD15 Monoclonal Antibody Imaging for Diagnosis of Equivocal Appendicitis

Department of Radiology, University of California, San Diego
Department of Surgery, University of California, Irvine
Departments of Imaging and Surgery, Tri-City Medical Center, Oceanside, California
Department of Nuclear Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania
Palatin Technologies, Inc., Princeton, New Jersey
Department of Nuclear Medicine, University of New Mexico, Albuquerque, New Mexico

Correspondence: For correspondence or reprints contact: Samuel L. Kipper, MD, Department of Nuclear Medicine, Tri-City Medical Center, 4002 Vista Way, Oceanside, CA 92056.

ABSTRACT

We evaluated ^99mTc-labeled anti-CD15 immunoglobulin M monoclonal antibody (LeuTech) for diagnosing acute appendicitis in patients with an equivocal clinical presentation. LeuTech avidly binds to circulating and sequestered human polymorphonuclear neutrophils in vivo, eliminating in vitro cell labeling and blood handling. Methods: We studied 49 patients to evaluate the safety and efficacy of LeuTech imaging. ^99mTc-labeled LeuTech was prepared on site using a lyophilized kit, ^99mTc-labeled pertechnetate, and 2 different incubation techniques, 1 at room temperature and the other at 37°C. The abdomen was serially imaged for up to 3 h after the intravenous administration of 370–740 MBq ^99mTc-labeled LeuTech. Scans were read as positive or negative for acute appendicitis or other intra-abdominal infection. The institutional diagnosis was established by surgery, other diagnostic studies, or 1-mo clinical follow-up. Results: Scans were positive for appendicitis in all 26 patients with appendicitis, for a sensitivity of 100%, and negative for appendicitis in 19 of 23 patients without appendicitis, for a specificity of 83%. Accuracy, positive predictive value, and negative predictive value were 92%, 87%, and 100%, respectively. Results were not different between the LeuTech preparations. The rate of laparotomies with negative findings in patients who underwent surgery was 10%. The average time from injection to LeuTech visualization in the appendix for cases positive for appendicitis was 9 min. No serious adverse reactions occurred. Conclusion: LeuTech imaging is safe, rapid, and sensitive for diagnosis of appendicitis in equivocal cases. The potential advantages of LeuTech over currently available radio-pharmaceuticals for infection imaging are ease of preparation, absence of blood handling, excellent image quality, no requirement for SPECT, and rapid diagnostic uptake.

Key Words: appendicitis • inflammatory diseases • infection imaging • neutrophils • ^99mTc-labeled anti-CD15 monoclonal antibody

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