A trial to evaluate the investigational device used for early prediction of response to neoadjuvant chemotherapy in breast cancer patients using Discrete Multi-Wavelength Near Infra-Red Spectroscopy (DMW-NIRS)
- Conditions
- Neoplasms
- Registration Number
- KCT0008798
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 60
1) Korean women over 19 years old and under 79 years old (as of the date of signing the consent form)
2) Patients with invasive breast cancer confirmed by biopsy
3) When surgery is planned after receiving neoadjuvant chemotherapy
4) If the patient voluntarily agree to participate after receiving a sufficient explanation about the study
5) If the patient have the will and ability to implement the procedures specified in the research plan
1) Women who may be pregnant or who are pregnant or lactating
2) If the measurement area has a mole, significant trauma or scar, or is suffering from mastitis
3) If the patient have a history of previous surgery for breast disease
4) If the patient have a breast implant or foreign body injected
5) When measurement is difficult due to pus coming out of the location of the lesion or skin deformation
6) Bilateral breast cancer or benign lesions in normal area
7) Metastatic breast cancer (stage IV)
8) If the patient have a history of photo allergy
9) In cases where participation in this study is deemed impossible by the medical judgment of the researcher (e.g., severe mental anxiety, physical weakness)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in tumor size and chromophores
- Secondary Outcome Measures
Name Time Method Safety: Any unfavorable medical findings resulting in symptoms not observed prior to study