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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36040

Enrollment

Registered

2011-08-19

Start date

2011-03-08

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer mammacarcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: breast cancer patients to receive neoadjuvant systemic therapy

Exclusion criteria

Exclusion criteria: breast implants

Design outcomes

Primary

Measure	Time frame
Differences in mean change of the Softscan parameters (HbO2, Hb, %water and scattering power) from the baseline to the different time intervals (1/6th, halfway, before surgery) between pathological responders and nonresponders	—

Secondary

Measure	Time frame
Difference of the change of the mean Softscan parameters in the tumor to the change in size and blood flow measured in the MRI and change in size during clinical assessment at the different time intervals. Difference in mean tumor size (cm) measured by the Softscan compared to MRI, ultrasound and clinical assessment. Differences between the Softscan mean parameters for the different tumor characteristics (tumor size, menopausal status, histological type, tumor differentiation grade) at baseline and prior to surgery to patient.	—

Measure

Time frame

Difference of the change of the mean Softscan parameters in the tumor to the change in size and blood flow measured in the MRI and change in size during clinical assessment at the different time intervals. Difference in mean tumor size (cm) measured by the Softscan compared to MRI, ultrasound and clinical assessment. Differences between the Softscan mean parameters for the different tumor characteristics (tumor size, menopausal status, histological type, tumor differentiation grade) at baseline and prior to surgery to patient.

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Countries

Netherlands

Outcome results