Diagnostic Performance of 18F-Fluoroestradiol PET/CT for Axillary Lymph Node Metastasis in Invasive Lobular Carcinoma: A Prospective Feasibility Study

J Nucl Med. 2025 Oct 1;66(10):1555-1560. doi: 10.2967/jnumed.125.269573.

Abstract

Invasive lobular breast cancer (ILC) presents diagnostic challenges with conventional imaging modalities. We aimed to evaluate the diagnostic performance of 18F-fluoroestradiol (18F-FES) PET/CT for axillary lymph node (ALN) metastasis in ILC. Methods: This prospective feasibility study was conducted between August 2023 and August 2024. Eligible patients had newly diagnosed estrogen receptor-positive ILC, had confirmed or suspected ALN metastasis on physical examination or imaging, and were scheduled to undergo axillary surgery. The presence of metastasis in ipsilateral ALN on 18F-FES PET/CT was assessed visually and semiquantitatively (SUVmax) and compared with surgical specimens. Results: In total, 20 women were included in the analysis. Twelve patients had surgically proven ALN metastasis. On visual analysis, 18F-FES PET/CT showed a sensitivity of 67% (8/12; 95% CI, 35%-90%) and a specificity of 100% (8/8; 95% CI, 63%-100%). All 4 false-negative cases had a single metastasis on the sentinel lymph node, with sizes of 1, 1.5, 6, and 6 mm. An unexpected 18F-FES-positive ipsilateral internal mammary lymph node was detected in 1 patient. The median SUVmax was 3.4 (interquartile range, 1.2-9.5) and 1.0 (interquartile range, 0.8-1.1) for metastatic and benign ALNs, respectively. With an optimal cutoff of at least 1.2, SUVmax showed a sensitivity of 75% (9/12; 95% CI, 43%-95%) and a specificity of 100% (8/8; 95% CI, 63%-100%). The area under the receiver operating curve was 0.89 (95% CI, 0.75-1.00). Three of 4 patients with false-negative fine-needle aspiration results for ALN were positive on 18F-FES PET/CT. Conclusion: 18F-FES PET/CT had excellent specificity and moderate sensitivity for detecting ALN metastasis in ILC, suggesting its potential as a valuable staging modality for early ILC.

Trial registration: ClinicalTrials.gov NCT05960201.

Keywords: 18F-FES PET; axillary; breast neoplasms; invasive lobular carcinoma; lymph node.

Publication types

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

MeSH terms

  • Axilla / diagnostic imaging
  • Axilla / pathology
  • Breast Neoplasms* / diagnosis
  • Breast Neoplasms* / pathology
  • Carcinoma, Lobular* / diagnosis
  • Carcinoma, Lobular* / secondary
  • Estradiol / administration & dosage
  • Estradiol / analogs & derivatives
  • Feasibility Studies
  • Female
  • Fluorine Radioisotopes
  • Humans
  • Lymphatic Metastasis* / diagnosis
  • Lymphatic Metastasis* / pathology
  • Middle Aged
  • Neoplasm Invasiveness
  • Neoplasm Staging / methods
  • Positron Emission Tomography Computed Tomography* / methods
  • Prospective Studies
  • Sensitivity and Specificity
  • Sentinel Lymph Node / diagnostic imaging
  • Sentinel Lymph Node / pathology

Substances

  • 16-fluoroestradiol
  • Estradiol
  • Fluorine Radioisotopes

Associated data

  • ClinicalTrials.gov/NCT05960201