A single-center assessor-blinded trial to investigate the efficacy and safety of microwave mammography IGS-0001 in patients with breast cancer and healthy women

Takao Shintaro0 个研究点目标入组 10 人开始时间: 2021年10月5日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Breast cancer (including suspected)
•(1) One of the following applies
•(a) Histologically diagnosed breast cancer by needle biopsy or fine-needle aspiration cytology
•(b) Patients who are suspected of having breast cancer based on an examination using a mammographic image diagnostic system or mammary ultrasonography.
•(2) The patient is a woman 20 years of age or older at the time of obtaining consent.
•(3) Japanese women.
•(4) Patients who agree to participate in the study of their own free will after receiving sufficient explanation of the contents of the study from the investigator or sub-investigator using the consent document and the explanation document.
•No breast cancer or suspicion of breast cancer
•(1) No history of breast cancer.
•(2) Have never been suspected of having breast cancer during screening using a mammographic image diagnostic system or mammary ultrasonography.
•(3) If the patient has undergone a screening using a diagnostic mammography system in the six months prior to the date of consent, the most recent images of the screening using a diagnostic mammography system can be collected.
•(4) The patient must be 20 years of age or older at the time of consent.
•(5) The subjects must be Japanese women.
•(6) The patient has received a full explanation of the contents of the study from the investigator or sub-investigator using the consent document and the explanation document, and freely and voluntarily agrees to participate in the study.

•(1) There is trauma with bleeding on the breast surface.
•(2) There is an artificial object such as silicone inserted into the breast.
•(3) It has not been more than 7 days since the needle biopsy or aspiration-assisted needle biopsy was performed.
•(4) Medication is being administered.
•(5) The patient has an implantable device such as a pacemaker.
•(6) The patient has a fever and is suspected to be infected.
•(7) Has a history of or is undergoing treatment for a serious psychiatric disorder, and the investigator or sub-investigator judges that it is difficult for the patient to participate in this study.
•(8) There is a possibility of pregnancy.
•(9) The subject is pregnant.
•(10) I am breastfeeding.
•(11) It is impossible to keep the patient lying on the bed during IGS-0001 (about 20 minutes).
•(12) Unable to keep his or her arms raised to the head for about 10 minutes during IGS-0001.
•(13) In addition, the investigator or sub-investigator judges that the subject is unsuitable.

发起方

Takao Shintaro