Tumor response assessment in breast cancer patients receiving neoadjuvant systemic therapy using optical mammography: the Softscan Study

Early detection of a poor response to neoadjuvant systemic treatment in breast
cancer is of great importance to be able to start a beter treatment and to
reduce the time that a patient is exposed to unnecessary and potentially
harmful treatment. However, the assessment of early tumor response to
neoadjuvant therapy remains one of the main challenges in breast cancer.
Current imaging modalities, such as MRI, are not optimal due to their sole
ability to detect anatomical changes and not to detect early physiological
changes. Optical imaging using near-infrared (NIR) light (700-900 nm) has
recently emerged as a promising alternative technique to visualize tumor tissue
and metabolic activity. Therefore, optical NIR imaging could offer the
opportunity of non-invasive in vivo monitoring of the response of the primary
tumor to neoadjuvant treatment.

Primary Objective:
* To investigate the value of the Softscan in the early prediction of tumor
response (RECIST criteria) to neoadjuvant chemotherapy or hormonal therapy in
breast cancer.

Secondary Objective:
* To assess the accuracy of the Softscan in tumor size calculations in
comparison to MRI, mammography or ultrasound at baseline.
* To assess the correlation between tumor response according to the Softscan
parameters (HbO2, Hb, %water and scattering power) and MRI parameters.
* To assess the correlation between changes in the Softscan parameters and
patient or tumor characteristics
* To assess new algorithms in data processing able to increase accuracy of the
Softscan and enhance response prediction.

* Feasibility study to evaluate the diagnostic value of the Softscan in
detection of early tumor response to neoadjuvant treatment.
* One Softscan device is installed and is operational at the LUMC
* Softscan scans will be made at baseline, at 1/6th of the treatment, halfway
treatment, and before surgery. (Figure 3)
* MRI scans will be made as part of standard-of-care (LUMC guidelines: at
baseline, halfway treatment and before surgery) or on request of the attending
physician.
* 32 patients are required for the group to receive chemotherapy (with or
without hormonal therapy) and 10 patients for the hormonal therapy alone.

This study will require patients during their period of neoadjuvant treatment
for 4 visits for a scan. These scans will take about 30 - 45 minutes and are
not painful to the patient.

Risks of the Softscan are limited to mild temporarely musculoskeletal pain,
Additionally, there is the minimal chance of a allergic reaction of the skin to
the optical medium fluids.