Research on the effectiveness and safety of microwave mammography

JRCT ID: jRCTs052180188

Registered date:26/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: breast cancer
• Date of first enrollment: 20/07/2017
• Target sample size: 400
• Study type: Interventional
• Intervention(s): none

Outcome(s)

Primary Outcome

Draw ability (Efficacy) of microwave
mammography image by microwave
mammography device

Secondary Outcome

1. We evaluate the safety from the viewpoint of the thermal action of the breast imaging diagnostic apparatus.
2. We evaluate the safety and usefulness of the protective seal.
3. Compared with X-ray mammography images, ultrasonic examination images, MRI examination images, etc., we evaluate the imaging ability of microwave mammography.
4. Clinical follow-up survey is performed, and compared with X-ray mammography image, super-wave inspection image, MRI inspection image etc. after the examination, the evaluation ability of microwave mammography is evaluated.

Key inclusion & exclusion criteria

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

Include criteria

1) Cancer patient: Breast cancer is suspected in diagnostic imaging or diagnosed as breast cancer by pathological diagnosis.
Other than cancer patients: Not suffering from breast cancer. (Including those who receive breast cancer examination.)
2) Regardless of gender, over 20 years old.
3) It is possible to maintain the supine state on the bed during the examination of about 20 minutes.
4) Regarding research participation, written informed consent was obtained from the subject himself.

Exclude criteria

1) There is a trauma that is not cured on the breast surface.
2) In addition, the subject who judged it though a study responsibility doctor or the medical attendant carried out this study safely if inadequate.
3) Pacemaker wearing person.

Related Information

• Primary Sponsor: Yamagami Kazuhiko
• Source(s) of Monetary Support: Integral Geometry Sciense,Japan Agency for Medical Research and Development