Implementation and benchmarking of a novel analytical framework to clinically evaluate tumor-specific fluorescent tracers

Nat Commun. 2018 Sep 18;9(1):3739. doi: 10.1038/s41467-018-05727-y.

Abstract

During the last decade, the emerging field of molecular fluorescence imaging has led to the development of tumor-specific fluorescent tracers and an increase in early-phase clinical trials without having consensus on a standard methodology for evaluating an optical tracer. By combining multiple complementary state-of-the-art clinical optical imaging techniques, we propose a novel analytical framework for the clinical translation and evaluation of tumor-targeted fluorescent tracers for molecular fluorescence imaging which can be used for a range of tumor types and with different optical tracers. Here we report the implementation of this analytical framework and demonstrate the tumor-specific targeting of escalating doses of the near-infrared fluorescent tracer bevacizumab-800CW on a macroscopic and microscopic level. We subsequently demonstrate an 88% increase in the intraoperative detection rate of tumor-involved margins in primary breast cancer patients, indicating the clinical feasibility and support of future studies to evaluate the definitive clinical impact of fluorescence-guided surgery.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Alkanesulfonic Acids / administration & dosage
  • Alkanesulfonic Acids / chemistry
  • Animals
  • Benchmarking*
  • Bevacizumab / administration & dosage
  • Bevacizumab / chemistry
  • Breast Neoplasms / diagnostic imaging*
  • Breast Neoplasms / surgery
  • Cell Line, Tumor
  • Feasibility Studies
  • Female
  • Fluorescent Dyes / administration & dosage*
  • Fluorescent Dyes / chemistry
  • Humans
  • Indoles / administration & dosage
  • Indoles / chemistry
  • Margins of Excision
  • Mastectomy / methods
  • Middle Aged
  • Molecular Imaging / methods*
  • Optical Imaging / methods
  • Surgery, Computer-Assisted / methods*

Substances

  • Alkanesulfonic Acids
  • Fluorescent Dyes
  • IRDye 800CW NHS ester
  • Indoles
  • Bevacizumab