Research on the effectiveness and safety of microwave mammography

JRCT ID: jRCTs052180114

Registered date:11/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: breast cancer
• Date of first enrollment: 11/01/2017
• Target sample size: 300
• Study type: Interventional
• Intervention(s): Irradiating weak microwaves from breast surface

Outcome(s)

• Primary Outcome: Drawability (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.

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Selection criteria for cancer patients
1) Breast cancer is suspected by imaging diagnosis or diagnosed as breast cancer by pathological diagnosis.
2) Regardless of sex, over 16 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. In the case of an underage, written informed consent has been obtained from parents.

Selection criteria for healthy person
1) Breast cancer is not suspected by diagnostic imaging.
2) Regardless of sex, over 16 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. In the case of an underage, written informed consent has been obtained from parents.

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.

Related Information

• Primary Sponsor: kunihisa tomonari
• Source(s) of Monetary Support: Integral Geometry Science,Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000023928