Breast Cancer Invasive Carcinoma
Conditions
Interventions
During the first phase of this study, we want to assess the usability and
functionality of the newly developed tissue sensing introducer with integrated
optical technology. For this, a variety of pa
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Major inclusion criteria BCS patients phase 1: • Woman, >= 18 years old • Histology proven invasive ductal carcinoma of the breast planned for BCS • Lesion visible on ultrasound • Lesions size = 6mm distance from dermis, nipple or pectoral muscle • Normal axillary ultrasound • Written informed consent Major inclusion criteria mastectomy patients phase 1: • Woman, >= 18 years old • Histology proven invasive ductal carcinoma of the breast planned for mastectomy • Lesion visible on ultrasound • Lesions size
Exclusion criteria
Exclusion criteria: Poor ultrasound visibility of the lesion Patients with breast implants History of breast related radiotherapy treatment Previous breast surgery Suspected oversensitivity to light; e.g. patient who has had photodynamic therapy Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In this proof of concept study (phase 1), we will use the tissue sensing VAB device with integrated DRS technology for ultrasound-guided VAE of small breast tumors. The goal of this study is to assess whether it is feasible and intuitive to perform DRS measurements in combination with a vacuum-assisted excision procedure. The main study endpoint is the usability and functionality of DRS in combination with a vacuum-assisted excision procedure. The ease of use of the developed tissue sensing VAB device will be reported by the involved radiologist(s). When necessary this information will be used to improve the functionality and optimize the design of this device for the next phase of this study. When phase 1 of the study is finished successfuly, defined as a 70% satisfacory scoring on the SUS scoring scale, we will proceed to phase 2 of the study. In this proof of concept study, we will use the definite sensing VAB device with integrated DRS technology for ultrasound-guided VAE of small breast tumors and will use a tissue sensing algorithm developed earlier in our group to guide the procedure. The aim of this study is to show that such a *smart* VAE procedure is safe and effective. Critical to this approach is to achieve a comparable radical resection rate to BCS. To this end, we will investigate the success rate of complete tumor excision by the *smart* VAE procedure by confirmatory surgery of the VAE excision cavity 3 weeks after the VAE procedure. Success will be defined as the absence of residual cancer tissue in the resected VAE cavity. It is hypothesized that the addition of tissue sensing technology to the standard VAE procedure can achieve a complete tumor removal success rate of 95%. The success rate of complete tumor removal will be determined by assessing the presence or absence of residual tumor tissue in the specimen of the resected VAE cavity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Only for phase 2 of the study: A time frame of 3 weeks between VAE and confirmatory surgery (instead of immediate excision) allows us to register short-term complications such as post-procedural pain, hematoma and infection. The secondary endpoint includes the results of questionnaires concerning complications, pain during and after the procedure, patient satisfaction, and short term cosmetic outcome. | — |
Countries
Netherlands
Outcome results
None listed