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Diagnosis and treatment monitoring of breast cancer by TRS-21-6W

Not Applicable
Recruiting
Conditions
breast cancer
Registration Number
JPRN-jRCTs042210158
Lead Sponsor
Koizumi Kei
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
60
Inclusion Criteria

1.Female patients age 20 or older
2.Patients with an initial diagnosis of primary breast cancer (including bilateral breast cancer)
3 Patients scheduled neoadjuvant chemotherapy or endocrine therapy
4.Patients whose consent for this study has been obtained by signing the consent form.

Exclusion Criteria

1.Patients with photosensitivity
2.Patients who cannot keep the same posture for the measurement time (about 40 minutes)
3.Patients with obvious distant metastasis (lung metastasis, liver metastasis, bone metastasis, etc.)
4.Patients with recurrent breast cancer
5.Patients who are judged by the principal investigator (or sub-investigator) to be in a condition inappropriate for the participation in the study

Study & Design

Study Type
Other
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
ongitudinal changes in optical data before neoadjuvant therapy and at early point of treatment, and changes in tumor size due to the therapy
Secondary Outcome Measures
NameTimeMethod
Relationship between optical data and MRI/CT and pathological results<br>Adverse events<br>Device deficiencies
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