Tumor response assessment in breast cancer patients receiving neoadjuvant systemic therapy using optical mammography: the Softscan Study
Recruiting
- Conditions
- breast cancermammacarcinoma10006291
- Registration Number
- NL-OMON36040
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 42
Inclusion Criteria
breast cancer patients to receive neoadjuvant systemic therapy
Exclusion Criteria
breast implants
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Differences in mean change of the Softscan parameters (HbO2, Hb, %water and<br /><br>scattering power) from the baseline to the different time intervals (1/6th,<br /><br>halfway, before surgery) between pathological responders and nonresponders</p><br>
- Secondary Outcome Measures
Name Time Method <p>Difference of the change of the mean Softscan parameters in the tumor to the<br /><br>change in size and blood flow measured in the MRI and change in size during<br /><br>clinical assessment at the different time intervals.<br /><br><br /><br>Difference in mean tumor size (cm) measured by the Softscan compared to MRI,<br /><br>ultrasound and clinical assessment.<br /><br><br /><br>Differences between the Softscan mean parameters for the different tumor<br /><br>characteristics (tumor size, menopausal status, histological type, tumor<br /><br>differentiation grade) at baseline and prior to surgery to patient. </p><br>