Evaluation of the Effect of Using Ultrasound Robots for Breast Cancer Screening: A Multicenter, Parallel-group, Cluster Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if robotic ultrasound screening works as well as or better than traditional sonographer-led screening for detecting breast cancer. It will also explore how well participants follow recommended post-screening care. The main questions it aims to answer are: Does robotic ultrasound screening detect more cases of breast cancer compared to traditional sonographer-led screening? How well do participants follow up on recommended care after robotic ultrasound screening? Researchers will compare robotic ultrasound screening to traditional sonographer-led screening to see if robotic ultrasound works effectively for breast cancer screening. Participants will: Receive a breast ultrasound performed either by a robotic system or a human sonographer. Undergo follow-up management based on their BI-RADS classification.

Вмешательства

• Устройство Screening of the subjects was conducted using an ultrasonic robot.
  The ultrasound robot automatically scans the breasts of subjects via its mechanical arm and generates images.The diagnosis is made based on the radiologist's interpretation of the images.

Первичные конечные точки

• The detection rate of breast cancer [Срок оценки: After participating in the screening, the subjects will be followed up for 24 months.]

Вторичные конечные точки (12)

• Cancer type [Срок оценки: After participating in the screening, the subjects will be followed up for 24 months.]
• The early diagnosis rate [Срок оценки: After participating in the screening, the subjects will be followed up for 24 months.]
• Lymph node status [Срок оценки: After participating in the screening, the subjects will be followed up for 24 months.]
• Breast cancer clinical stage [Срок оценки: After participating in the screening, the subjects will be followed up for 24 months.]
• Histological Grading of Breast Cancer [Срок оценки: After participating in the screening, the subjects will be followed up for 24 months.]
• Breast cancer screen recall rate [Срок оценки: After participating in the screening, the subjects will be followed up for 24 months.]
• The positive predictive value [Срок оценки: After participating in the screening, the subjects will be followed up for 24 months.]
• The breast cancer biopsy rate [Срок оценки: After participating in the screening, the subjects will be followed up for 24 months.]
• Referral adherence rate [Срок оценки: After participating in the screening, the subjects will be followed up for 24 months.]
• Interval cancer incidence [Срок оценки: After participating in the screening, the subjects will be followed up for 24 months.]
• Breast cancer mortality [Срок оценки: After participating in the screening, the subjects will be followed up for 24 months.]
• All-cause mortality [Срок оценки: After participating in the screening, the subjects will be followed up for 24 months.]

Критерии участия

Критерии включения

• women aged 35-64 years
• no history of breast cancer
• ownership and ability to use a smartphone
• willingness to participate in the screening program.

Критерии исключения

• Women who have undergone breast removal surgery;
• Pregnant and lactating women;
• Women who have undergone breast cancer screening within the past year;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Скрининг

Центры проведения

Китай · 1 центр

• Rural health centers and community health centers — Xiantao

Идентификаторы

NCT: NCT07331363 · HuazhongU20251203

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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