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Breathprints for Breast Cancer: Evaluating a Non-Invasive Approach to BI-RADS 4 Risk Stratification in a Preliminary

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  • 1Noze, 4920 Pl. Olivia, Saint-Laurent, QC H4R 2Z8, Canada.

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Exhaled breath analysis shows promise in identifying breast cancer in BI-RADS 4 patients, potentially reducing unnecessary biopsies. This non-invasive method achieved high accuracy, offering a new tool for diagnostic decision-making.

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BI-RADS 4autoencoderbreast cancerbreath analysischemiresistive sensor arraydigital olfaction (electronic nose)machine learningmulti-modal fusionrisk stratificationrule-out diagnosticsvolatile organic compounds (VOCs)

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Area of Science:

  • Oncology
  • Medical Diagnostics
  • Biotechnology

Background:

  • Breast cancer is a leading cause of mortality in women, necessitating accurate early detection methods.
  • The Breast Imaging Reporting and Data System (BI-RADS) classification aids reporting, but BI-RADS 4 poses diagnostic challenges due to a wide malignancy risk spectrum (2-95%).
  • Many patients with BI-RADS 4 findings undergo unnecessary biopsies, increasing healthcare costs and patient burden.

Purpose of the Study:

  • To evaluate the efficacy of exhaled breath analysis in differentiating malignant from benign breast lesions in patients classified under BI-RADS 4.
  • To assess the potential of breath analysis as a non-invasive tool to reduce unnecessary invasive procedures.

Main Methods:

  • Breathprints were collected from 85 participants (BI-RADS 3-5) using an electronic nose (eNose) breathalyzer.
  • An autoencoder model integrated breath data with BI-RADS scores for malignancy prediction.
  • Model performance was validated using cross-validation, prioritizing high sensitivity to minimize false negatives.

Main Results:

  • The study analyzed breath samples from 68 benign and 17 malignant BI-RADS 4 cases.
  • The breath analysis model demonstrated a mean sensitivity of 88%, specificity of 75%, and a negative predictive value (NPV) of 97%.
  • Performance remained consistent across BI-RADS 4 subcategories, with notable sensitivity in higher-risk groups.

Conclusions:

  • Exhaled breath analysis can effectively distinguish malignant from benign findings in BI-RADS 4 patients.
  • The high NPV suggests this method can serve as a reliable non-invasive tool to rule out malignancy, reducing unnecessary biopsies.
  • Further multi-center studies are recommended to validate these findings and explore clinical implementation.