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

Background: The Dynamic Optical Breast Imaging (DOBI) ComfortScan system is a dynamic optical breast functional imaging system that analyses diffused light propagation through breast tissue. It continuously records the physiological properties of the tissue by applying a certain amount of pressure to the breasts that induces changes in blood hemoglobin concentration and the metabolic rates associated with the tumor angiogenesis of breast cancer. This study examined the clinical performance of dynamic optical functional imaging in the detection of malignant lesions, and compared the DOBI system with conventional imaging modalities. This novel diagnostic test addresses critical limitations of conventional imaging by providing functional assessment of tumor angiogenesis through hemoglobin dynamics, particularly valuable for dense-breast patients where mammography (MG) sensitivity declines. Methods: Patients with clinical ultrasound (US) and/or MG results, as well as biopsy results, at the Zhejiang Cancer Hospital in China were recruited for this study between March 2022 and November 2023. The study was designed to evaluate the effectiveness of the DOBI system in diagnosing malignant lesions of the breast. The pathology results from a surgical or core-needle biopsy were used as the standard. We prospectively enrolled 282 patients (320 lesions) with biopsy-confirmed diagnoses from Zhejiang Cancer Hospital [2022-2023]. Diagnostic accuracy metrics (sensitivity, specificity, positive predictive value and negative predictive value) were calculated against histopathology gold standard, with comparative analysis against US, MG, and magnetic resonance imaging (MRI). Results: The data of 320 lesion cases were collected, including both the biopsy results and DOBI images. Of these, 180 cases had DOBI, US, and biopsy results, while 149 cases had DOBI, MG, and biopsy results. The accuracy (ACC), sensitivity (SEN), specificity (SPE), positive predictive value (PPV), and negative predictive value (NPV) of the DOBI system for breast cancer diagnosis were 81.25%, 95.96%, 74.66%, 62.91%, and 97.63%, respectively. The cohort comprised 35% malignant (n=98) and 65% benign (n=184) lesions, predominantly in 40-60 years old (67%) with A/B-cup breasts (87%). DOBI demonstrated 95.96% sensitivity and 74.66% specificity, outperforming US (91.38%/57.6%) and comparable to MG (78.57%/85.32%). Conclusions: The DOBI system had both a high SEN (95.96%) and a high NPV (97.63%), as well as an acceptable SPE (74.66%). This suggests that it has the potential to serve as a supplementary diagnostic method for the detection of breast cancer. The study also showed that combining the DOBI system with conventional imaging modalities (e.g., US or MG) could significantly reduce false-negative (FN) and false-positive (FP) breast cancer diagnoses. As a radiation-free, low-cost functional imaging tool, DOBI shows potential as a triage test to reduce unnecessary biopsies (FP reduction: US 52→15, MG 16→3) and prevent missed diagnoses (FN elimination: US 5→0, MG 9→0) when combined with conventional imaging. Multicenter validation is warranted given single-center design limitations.