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

JRCT ID: jRCTs042210158

Registered date:07/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: breast cancer
• Date of first enrollment: 04/04/2022
• Target sample size: 60
• Study type: Other
• 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 Outcome: Longitudinal changes in optical data before neoadjuvant therapy and at early point of treatment, and changes in tumor size due to the therapy

Secondary Outcome

Relationship between optical data and MRI/CT and pathological results
Adverse events
Device deficiencies

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Koizumi Kei
• Secondary Sponsor: Hamamatsu Photonics K.K.