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Exploratory clinical trial using a ring type breast ultrasonic imaging device (ring echo)

Exploratory clinical trial using a ring type breast ultrasonic imaging device (ring echo)

191

Women, aged 20 or older, who had been suspected of having breast cancer or who had been diagnosed of breast cancer were enrolled. 197 patients were enrolled but 6 patients withdrew before screening. Consequently, we conducted ring echo screening for these 191 patients, 91 breast cancer suspect patients and 100 breast cancer patients. The average age of these 191 patients was 52.

October 29, 2019: The first case registration at Showa University Hospital January 20, 2020: Case registration started at Shonan Memorial Hospital (The 39th case was completed at Showa University Hospital) March 19, 2020: Final case registered at both hospitals Total number of cases at Showa University Hospital: 86 Total number of cases at Shonan Memorial Hospital: 111

No adverse events occurred

As for Primary Outcome, the coincidence ratio of finding lesions to be examined was analyzed. It was conducted under two conditions; one is when BI-RADS category 3 or higher was set for detailed examination and the other is when BI-RADS category 4 (4a) or higher was set for detailed examination. The coincidence ratio and its exact 95% confidence interval between the ring echo test and handheld ultrasonic test is shown as below. Analysis under category 3 or higher: 55.4% (50.1%, 60.7%) Analysis under category 4 or higher: 69.1% (64.0%, 73.9%) However, regarding the appropriateness of the selection of categories, further study will be required in the future.

This study succeeded in examining 191 patients and obtaining breast ultrasonic images to exploratory evaluate the safety and efficacy of the device for breast cancer screening. Regarding safety, no adverse events was found and 93% of the respondents were comfortable with the breast cancer screening with it. Regarding efficacy, we successfully described the internal structure of the breasts. In the future, we will collaborate with clinicians to create image interpretation guidelines for ring echo images.

Sept. 16, 2020

Undecided

Undecided

https://jrct.mhlw.go.jp/latest-detail/jRCTs032190078

Akashi Sadako

Showa University Hospital

1-5-8, Hatanodai, Shinagawa, Tokyo

sakashi@med.showa-u.ac.jp

Ide Yoshimi

Showa University Hospital

1-5-8, Hatanodai, Shinagawa, Tokyo

+81-3-3784-8000

ideyoshimi@med.showa-u.ac.jp

Complete

Oct. 25, 2019

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

1) Breast cancer suspect patients or breast cancer patients before any treatment
2) Female, age 20 or older at the time of consent acquisition
3) Agreed in a written informed consent

1)Currently breastfeeding
2)Bilateral or unilateral mastectomy
3)Unable to get on and off the ring echo device by oneself or unable to lay prone on the ring echo device for 30 minutes
4)Pregnant or may be pregnant
5) Judged by a doctor to be in a condition inappropriate for the participation in the study

Female

Breast diseases

Breast imaging using a device

Coincidence of finding lesions to be examined

1)Coincidence of category
2)Diagnostic Ability of ring echo device

+81-3-3784-8129

Feb. 19, 2019

none