NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs042210158

Registered date:07/03/2022

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedbreast cancer
Date of first enrollment04/04/2022
Target sample size60
Countries of recruitment
Study typeOther
Intervention(s)Obtain consent from patients who have been diagnosed with breast cancer. After consent is obtained, treatment will be performed according to the treatment plan. Study subjects who will receive neoadjuvant therapy will be measured with the TRS-21-6W at the beginning of the therapy and before surgery.

Outcome(s)

Primary OutcomeLongitudinal changes in optical data before neoadjuvant therapy and at early point of treatment, and changes in tumor size due to the therapy
Secondary OutcomeRelationship between optical data and MRI/CT and pathological results Adverse events Device deficiencies

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderFemale
Include criteria1.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.
Exclude criteria1.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

Related Information

Contact

Public contact
Name Nobuko Yoshizawa
Address 1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka Shizuoka Japan 431-3192
Telephone +81-53-435-2242
E-mail nonchan@hama-med.ac.jp
Affiliation Hamamatsu University Hospital
Scientific contact
Name Kei Koizumi
Address 1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka Shizuoka Japan 431-3192
Telephone +81-53-435-2276
E-mail koizumi@hama-med.ac.jp
Affiliation Hamamatsu University School of Medicine