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Annals of Surgical Oncology

, Volume 24, Issue 11, pp 3167–3173 | Cite as

Intraoperative Tumor Detection Using a Ratiometric Activatable Fluorescent Peptide: A First-in-Human Phase 1 Study

  • Jonathan T. Unkart
  • Steven L. Chen
  • Irene L. Wapnir
  • Jesús E. González
  • Alec Harootunian
  • Anne M. WallaceEmail author
Breast Oncology

Abstract

Background

Positive surgical margins remain a significant challenge in breast cancer surgery. This report describes the use of a novel, first-in-human ratiometric activatable cell-penetrating peptide in breast cancer surgery.

Methods

A two-part, multi-institutional phase 1 trial of AVB-620 with a 3+3 dose escalation and dose-expansion cohorts was conducted. The patients received an infusion of AVB-620 2–20 h before planned lumpectomy/mastectomy and sentinel node biopsy/axillary dissection. Imaging analysis was performed on images obtained from the surgical field as well as post-excision surgical specimens. Pathology reports were obtained to correlate imaging results with histopathologic data. Information on physical adverse events and laboratory abnormalities were recorded.

Results

A total of 27 patients received infusion of AVB-620 and underwent surgical excision of breast cancer. The findings showed no adverse events or laboratory values attributable to infusion of AVB-620. The 8-mg dose was selected from the dose-escalation cohort for use with the expansion cohort based on imaging data. Region-of-interest (ROI) imaging analysis from the 8-mg cohort demonstrated measurable changes between pathology confirmed tumor-positive and tumor-negative tissue.

Conclusion

Intraoperative imaging of surgical specimens after infusion with AVB-620 allowed for real-time tumor detection. Infusion of AVB-620 is safe and may improve intraoperative detection of malignant tissue during breast cancer operations.

Notes

Acknowledgment

The authors acknowledge the Clinical Trials Office at Moores Cancer Center for their administrative oversight. Avelas Biosciences, Inc. paid for the clinical trial and administrative support.

Disclosure

Steven L. Chen, Jesús E. González, and Alec Harootunian are employees of Avelas Biosciences, Inc and have financial stock options. Jonathan T. Unkart, Irene L. Wapnir, and Anne M. Wallace have no disclosures.

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Copyright information

© Society of Surgical Oncology 2017

Authors and Affiliations

  • Jonathan T. Unkart
    • 1
  • Steven L. Chen
    • 2
  • Irene L. Wapnir
    • 3
  • Jesús E. González
    • 2
  • Alec Harootunian
    • 2
  • Anne M. Wallace
    • 1
    Email author
  1. 1.Department of Surgery, Moores Cancer CenterUniversity of California, San DiegoLa JollaUSA
  2. 2.Avelas Biosciences, Inc.La JollaUSA
  3. 3.Department of SurgeryStanford UniversityStanfordUSA

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