Intraoperative imaging of folate receptor alpha positive ovarian and breast cancer using the tumor specific agent EC17

Oncotarget. 2016 May 31;7(22):32144-55. doi: 10.18632/oncotarget.8282.

Abstract

Introduction: Intraoperative fluorescence imaging of the folate-receptor alpha (FRα) could support completeness of resection in cancer surgery. Feasibility of EC17, a FRα-targeting agent that fluoresces at 500nm, was demonstrated in a limited series of ovarian cancer patients. Our objective was to evaluate EC17 in a larger group of ovarian cancer patients. In addition, we assessed the feasibility of EC17 in patients with breast cancer.

Methods: Two-to-three hours before surgery 0.1mg/kg EC17 was intravenously administered to 12 patients undergoing surgery for ovarian cancer and to 3 patients undergoing surgery for biopsy-proven FRα-positive breast cancer. The number of lesions/positive margins detected with fluorescence and concordance between fluorescence and tumor- and FRα-status was assessed in addition to safety and pharmacokinetics.

Results: Fluorescence imaging in ovarian cancer patients allowed detection of 57 lesions of which 44 (77%) appeared malignant on histopathology. Seven out of these 44 (16%) were not detected with inspection/palpation. Histopathology demonstrated concordance between fluorescence and FRα- and tumor status. Fluorescence imaging in breast cancer patients, allowed detection of tumor-specific fluorescence signal. At the 500nm wavelength, autofluorescence of normal breast tissue was present to such extent that it interfered with tumor identification.

Conclusions: FRα is a favorable target for fluorescence-guided surgery as EC17 produced a clear fluorescent signal in ovarian and breast cancer tissue. This resulted in resection of ovarian cancer lesions that were otherwise not detected. Notwithstanding, autofluorescence caused false-positive lesions in ovarian cancer and difficulty in discriminating breast cancer-specific fluorescence from background signal. Optimization of the 500nm fluorophore, will minimize autofluorescence and further improve intraoperative tumor detection.

Keywords: breast cancer; fluorescence; folate-receptor alpha; image-guided surgery; ovarian cancer.

Publication types

  • Clinical Trial

MeSH terms

  • Administration, Intravenous
  • Adult
  • Aged
  • Biomarkers, Tumor / analysis*
  • Breast Neoplasms / chemistry*
  • Breast Neoplasms / pathology
  • Breast Neoplasms / surgery
  • False Positive Reactions
  • Feasibility Studies
  • Female
  • Fluorescein-5-isothiocyanate / administration & dosage*
  • Fluorescein-5-isothiocyanate / adverse effects
  • Fluorescein-5-isothiocyanate / pharmacokinetics
  • Fluorescent Dyes / administration & dosage*
  • Fluorescent Dyes / adverse effects
  • Fluorescent Dyes / pharmacokinetics
  • Folate Receptor 1 / analysis*
  • Folic Acid / administration & dosage
  • Folic Acid / adverse effects
  • Folic Acid / analogs & derivatives*
  • Folic Acid / pharmacokinetics
  • Humans
  • Intraoperative Care
  • Luminescent Measurements
  • Middle Aged
  • Netherlands
  • Optical Imaging / methods*
  • Ovarian Neoplasms / chemistry*
  • Ovarian Neoplasms / pathology
  • Ovarian Neoplasms / surgery
  • Predictive Value of Tests
  • Reproducibility of Results

Substances

  • Biomarkers, Tumor
  • FOLR1 protein, human
  • Fluorescent Dyes
  • Folate Receptor 1
  • Folic Acid
  • Fluorescein-5-isothiocyanate