Diffuse reflectance spectroscopy measurements during a ultrasound guided vacuum assisted excision procedure of breast tumors
- Conditions
- Breast CancerInvasive Carcinoma10006295
- Registration Number
- NL-OMON56338
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 78
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 <= 25 mm on MRI and US
• No associated mammographic microcalcifications outside the lesion
• Lesion >= 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 <= 25 mm on MRI and US
• Written informed consent
Major inclusion criteria for phase 2 are the same as phase 1 (patients
scheduled for BCS) with an additional inclusion criterium:
• Patients with invasive ductal carcinomas only and an ERpos /HER2neg tumor
type.
Neo-adjuvant chemotherapy treatment
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method