PurposeThis is the first clinical evaluation of a novel fluorescent imaging agent (Omocianine) for breast cancer detection with diffuse optical tomography (DOT).ProceduresEleven women suspected of breast cancer were imaged with DOT at multiple time points (up to 24 h) after receiving an intravenous injection of Omocianine (doses 0.01 to 0.1 mg/kg bodyweight). Breast MRI was obtained for comparison.ResultsHistopathology showed invasive cancer in ten patients and fibroadenoma in one patient. With the lowest dose of Omocianine, two of three lesions were detected; with the second dose, three of three lesions were detected; with the two highest doses, none of five lesions were detected. Lesion location on DOT showed excellent agreement with MRI. Optimal lesion-to-background signals were obtained after 8 h. No adverse events occurred.ConclusionsLowest doses of Omocianine performed best in lesion detection; DOT using a low-dose fluorescent agent is feasible and safe for breast cancer visualization in patients.

This paper presents an evaluation of a prototype diffuse optical tomography (DOT) system. Seventeen women with 18 breast lesions (10 invasive carcinomas, 2 fibroadenomas, and 6 benign cysts; diameters 13-54 mm) were evaluated with DOT and magnetic resonance imaging (MRI). A substantial fraction of the original 36 recruited patients could not be examined using this prototype due to technical problems. A region of interest (ROI) was drawn at the lesion position as derived from MRI and at the mirror image site in the contralateral healthy breast. ROIs were assessed quantitatively and qualitatively by two observers independently in two separate readings. Intra-and interobserver agreements were calculated using kappa statistics (k) and intraclass correlation coefficients (ICCs). Discriminatory values for presence of malignancy were determined by receiver operating characteristic (ROC) analyses. Intraobserver agreements were excellent (k 0.88 and 0.88; ICC 0.978 and 0.987), interobserver agreements were good to excellent (k 0.77-0.95; ICC 0.96-0.98). Discriminatory values for presence of malignancy were 0.92-0.93 and 0.97-0.99 for quantitative and qualitative ROC analysis, respectively. This DOT system has the potential to discriminate malignant from benign breast tissue in a reproducible qualitative and quantitative manner. Important technical improvements are required before this technique is ready for clinical application.

Purpose: The purpose of this study was to validate a newly developed diffuse optical tomography (DOT) system on benign cysts in the breast. Procedures: Eight patients with 20 benign cysts were included. Study procedures consisted of optical breast imaging and breast magnetic resonance imaging (MRI) for comparison. A reconstruction algorithm computed three-dimensional images for each of the four near-infrared wavelengths used by our DOT system (Philips Healthcare, Best, The Netherlands). These images were combined using a spectroscopic model to assess tissue composition and lesion size. Results: Twenty cysts were analyzed in eight patients. By using the spectroscopic information, 13 of 20 cysts (65%) were visualized with DOT, confirming their high water and low total hemoglobin content. Lesion size and location showed good agreement with MRI; Pearson correlation coefficient was 0.7 (p G 0.01). Conclusions: DOT can visualize benign cysts in the breast and elucidate their high water and low total hemoglobin content by spectroscopic analysis.