A single-center, exploratory investigator initiated trial to evaluate the effectiveness and safety of 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)

Asan Medical Center0 个研究点目标入组 60 人开始时间: 待定最近更新: 2023年9月18日

试验速览

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•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)

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