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From the Departments of Pathology (Dr Dintzis) and Surgery (Ms Hales and Drs Calhoun, Javid, and Byrd), University of Washington Medical Center, Seattle; Breast Surgery Clinic (Dr Harrington), Department of Pathology (Dr Tan), and Clinical Trials (Mses Fortney and Porenta), Overlake Hospital Medical Center, Bellevue, Washington; Development (Dr Miller), Clinical Operations (Mses Ishak and Gombotz), Research (Ms Hansen and Dr Parrish-Novak), and Device Development (Dr Kittle and Mr Perry), Blaze Bioscience, Inc., Seattle, Washington; and the Department of Surgery, University of Washington, Seattle (Dr Anderson).
Published: September 2019
AI Article Synopsis
Article Abstract
Context.—: Resection of breast carcinoma with adequate margins reduces the risk of local recurrence and reoperation. Tozuleristide (BLZ-100) is an investigational peptide-fluorophore agent that may aid in intraoperative tumor detection and margin assessment. In this study, fluorescence imaging was conducted ex vivo on gross breast pathology specimens.
Objectives.—: To determine the potential of tozuleristide to detect breast carcinoma in fresh pathology specimens and the feasibility of fluorescence-guided intraoperative pathology assessment of surgical margins.
Design.—: Twenty-three patients received an intravenous bolus dose of 6 or 12 mg of tozuleristide at least 1 hour before surgery. Fifteen lumpectomy and 12 mastectomy specimens were evaluated for fluorescence by the site's clinical pathology staff using the SIRIS, an investigational near-infrared imaging device. The breast tissue was then processed per usual procedures. Fluorescent patterns were correlated with the corresponding hematoxylin-eosin-stained sections. Clinical pathology reports were used to correlate fluorescent signal to grade, histotype, prognostic marker status, and margin measurements.
Results.—: Tozuleristide fluorescence was readily observed in invasive and in situ breast carcinoma specimens. Most invasive carcinomas were bright and focal, whereas in situ lesions demonstrated a less intense, more diffuse pattern. Tozuleristide was detected in ductal and lobular carcinomas with a similar fluorescent pattern. Fluorescence was detected in high- and low-grade lesions, and molecular marker/hormone receptor status did not affect signal. Fluorescence could be used to identify the relationship of carcinoma to margins intraoperatively.
Conclusions.—: Tumor targeting with tozuleristide allowed visual real-time distinction between pathologically confirmed breast carcinoma and normal tissue.
