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Article ; Online: Real-time Visualization of Breast Carcinoma in Pathology Specimens From Patients Receiving Fluorescent Tumor-Marking Agent Tozuleristide.

Dintzis, Suzanne M / Hansen, Stacey / Harrington, Kristi M / Tan, Lennart C / Miller, Dennis M / Ishak, Laura / Parrish-Novak, Julia / Kittle, David / Perry, Jeff / Gombotz, Carolyn / Fortney, Tina / Porenta, Stephanie / Hales, Lisa / Calhoun, Kristine E / Anderson, Benjamin O / Javid, Sara H / Byrd, David R

Archives of pathology & laboratory medicine

2018  Volume 143, Issue 9, Page(s) 1076–1083

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 ... ...

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.
MeSH term(s) Breast Carcinoma In Situ/diagnostic imaging ; Breast Carcinoma In Situ/pathology ; Breast Carcinoma In Situ/surgery ; Breast Neoplasms/diagnostic imaging ; Breast Neoplasms/surgery ; Carcinoma, Ductal, Breast/diagnostic imaging ; Carcinoma, Ductal, Breast/pathology ; Carcinoma, Ductal, Breast/surgery ; Carcinoma, Lobular/diagnostic imaging ; Carcinoma, Lobular/pathology ; Carcinoma, Lobular/surgery ; Female ; Fluorescent Dyes ; Humans ; Indocyanine Green/analogs & derivatives ; Intraoperative Care/methods ; Margins of Excision ; Mastectomy ; Mastectomy, Segmental ; Neoplasm Invasiveness/diagnostic imaging ; Neoplasm Invasiveness/pathology ; Prognosis ; Scorpion Venoms
Chemical Substances Fluorescent Dyes ; Scorpion Venoms ; Chlorotoxin (06UV5RFW57) ; tozuleristide (835UH424TU) ; Indocyanine Green (IX6J1063HV)
Language English
Publishing date 2018-12-14
Publishing country United States
Document type Clinical Trial, Phase I ; Journal Article ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID 194119-7
ISSN 1543-2165 ; 0363-0153 ; 0096-8528 ; 0003-9985
ISSN (online) 1543-2165
ISSN 0363-0153 ; 0096-8528 ; 0003-9985
DOI 10.5858/arpa.2018-0197-OA
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