A diagnostic test evaluation: dynamic optical functional imaging system for early-stage breast cancer detection

Area of Science:

• Medical Imaging
• Oncology
• Biomedical Engineering

Background:

• Dynamic Optical Breast Imaging (DOBI) ComfortScan analyzes light propagation for breast tissue physiology.
• It assesses hemoglobin dynamics and metabolic rates linked to tumor angiogenesis in breast cancer.
• DOBI offers functional insights valuable for dense breasts, where mammography sensitivity is limited.

Purpose of the Study:

• To evaluate the clinical performance of the DOBI system for detecting malignant breast lesions.
• To compare the diagnostic accuracy of DOBI against conventional imaging modalities (Ultrasound, Mammography, MRI).

Main Methods:

• Prospective enrollment of 282 patients (320 lesions) with biopsy-confirmed diagnoses at Zhejiang Cancer Hospital (2022-2023).
• DOBI system performance assessed against histopathology as the gold standard.
• Comparative analysis included diagnostic accuracy metrics (sensitivity, specificity, PPV, NPV) versus Ultrasound, Mammography, and MRI.

Main Results:

• DOBI demonstrated high sensitivity (95.96%) and negative predictive value (97.63%), with acceptable specificity (74.66%).
• DOBI outperformed Ultrasound in sensitivity and specificity, and was comparable to Mammography.
• The study included 35% malignant and 65% benign lesions, with the majority of patients aged 40-60.

Conclusions:

• DOBI shows potential as a supplementary diagnostic tool for breast cancer detection due to its high sensitivity and NPV.
• Combining DOBI with conventional imaging significantly reduces false negatives and false positives.
• As a radiation-free, low-cost tool, DOBI could serve as an effective triage test, reducing unnecessary biopsies and missed diagnoses.