OT2-05-02: ACRIN 6691 Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging (DOSI).

Background Imaging technologies monitoring and predicting breast cancer response to neoadjuvant chemotherapy (NAC) are of increasing interest. The utility of conventional imaging approaches varies and identifies the need for alternate functional imaging strategies. The use of model-based photon migration methods to quantitatively separate light absorption from scattering in multiply-scattering tissues is a type of near-infrared spectroscopy (NIRS) broadly referred to as diffuse optical spectroscopy (DOS) [Bevilacqua, et al. Applied Optics, 2000; Jakubowski, et al. , J of Applied Optics, 2009]. DOSI is a promising experimental technology that allows patients undergoing NAC to be followed with a “no significant risk” device meeting Food and Drug Administration criteria for exempt status. The current design is a mobile device which offers increased accessibility and is relatively simple to perform and interpret, as compared to mammography, magnetic resonance imaging, and positron emission tomography. Due to its size and portability, DOSI is a low barrier-to-access technology, creating new opportunities for patients to receive personalized treatment and for physicians to gain new insight into response mechanisms. The long-term goal is to provide oncologists with a relatively simple, risk-free bedside tool that can be used to help inform medical decisions on chemotherapy regimen, duration, and timing of surgery, thereby maximizing therapeutic response and minimizing unnecessary toxicity. Trial design : In this phase I/II prospective single arm study, patients will receive SOC NAC at five (5) NCI Network for Translational Research in Optical Imaging (NTROI) clinical sites with identical DOSI instruments and procedures. Patients will receive four DOSI exams: at baseline before chemotherapy, at early therapy 5–10 days after NAC initiation, at mid therapy, and at post therapy prior to surgery. The protocol will evaluate a harmonized DOSI technology platform that has been standardized for NAC monitoring. Eligibility : Women who have been diagnosed with breast cancer, have had confirmation by pre-treatment biopsy, and are scheduled to receive NAC followed by surgery are eligible for this trial. Specific aims : The primary aim of this clinical trial is to determine whether the baseline to mid-therapy changes in the DOSI measurement of the quantitative tumor tissue optical index can predict final pathologic complete response in patients with breast cancer undergoing NAC. The secondary aims investigate the correlation between additional DOSI quantitative measurements of tumor biochemical composition obtained at other timepoints, the full range of pathologic response (i.e. complete, partial, and non-response), and any corresponding imaging measurements. Statistical methods : Logistic regression models will be used to study the relationships between pathological complete response and percent change in tissue optical index tumor to normal ratio at different imaging time points. Study size : A total of sixty (60) patients will be enrolled in this imaging study. Currently, one patient has accrued. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr OT2-05-02.