Medical-AI trial: AI ultrasound screening for ovarian cancer in postmenopausal women — a field with no effective screening (ASTOM) (NCT07660718)

1Ovarian cancer has no effective screening

Ovarian cancer rarely causes early symptoms and is often advanced by the time it is found. Unlike breast or cervical cancer, no widely available, effective screening method is established, so early detection is hard, and it is the leading cause of death among gynecologic cancers in developed countries. Postmenopausal women in particular are at higher risk.

Gynecologic ultrasound is the first-line tool for evaluating the ovaries, but telling benign from malignant requires expert reading.

2Bringing AI to ultrasound assessment

This study (ASTOM) examines whether AI can be brought into that ultrasound evaluation, as a single-center prospective observational pilot. Per the registry summary, at a gynecologic-oncology unit of an academic hospital (IRCCS) in Bologna, Italy, it evaluates in postmenopausal women whether applying AI to ultrasound can discriminate ovarian-lesion risk categories.

The primary outcome is the predictive performance of the integrated model in accurately telling apart the different risk categories. The size is 100 patients, with enrollment closed and analysis underway.

3Cancers with a screening test, and those without

The difficulty of ovarian cancer becomes clear beside breast and cervical cancer. The path to early detection itself is not established.

Gynaecological ultrasound is the first choice for assessing the ovary, while telling benign from malignant requires specialist reading. Raising the discriminating power of an existing examination, without adding equipment, could help pick up disease early in high-risk groups. This is a single-centre pilot of 100 cases evaluating predictive performance.