Contrast-enhanced Ultrasound Evaluation of Indeterminate Ovarian Lesions: Prospective Multicenter Study

The goal of this clinical trial is to learn how well contrast-enhanced ultrasound (CEUS) can diagnose ovarian cancer in patients with indeterminate or suspicious ovarian/adnexal lesions identified on routine ultrasound or MRI. The main questions it aims to answer are: How accurately can qualitative CEUS imaging features distinguish malignant from benign ovarian/adnexal lesions? How consistent are the CEUS assessments among different readers, and can combining CEUS findings with MRI and clinical information improve diagnostic performance? Participants will: Undergo a baseline pelvic ultrasound followed by CEUS imaging using an intravenous ultrasound contrast agent. Receive a second contrast injection during the same examination so that additional CEUS images can be obtained. Be followed for up to 1 year, with standard-of-care imaging or pathology used as the reference for determining whether the ovarian/adnexal lesion is benign or malignant.

Inclusion Criteria: * All subjects accepted for this trial must be: * Patients ≥ 18 years of age. * Capable of making informed decisions regarding her treatment. * Have an ovarian or adnexal lesion categorized as O-RADS US 3-5 on conventional US, OR * Have an ovarian or adnexal lesion categorized as O-RADS MRI 3-5 on pelvic MRI Exclusion Criteria: * Subjects with any of the following will be excluded from this trial: * Patients with physiological or definitely benign ovarian or adnexal lesions (O-RADS 1-2). * Patients who are pregnant or lactating. * Patients with ovarian or adnexal lesions less than 1 cm or greater than 15 cm in size. * Patients with contraindications to CEUS. * Patients who are medically unstable, terminally ill, or whose clinical course is unpredictable.