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

Ovarian Cancer, Adnexal Lesion

Contrast-enhanced ultrasound, CEUS, Ovarian Cancer, Ovarian Lesions, Adnexal Lesions, O-RADS US 3-5, O-RADS MRI 3-5, contrast-enhanced MRI

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.

This project introduces several groundbreaking advancements to ovarian cancer diagnosis: first prospective validation of contrast-enhanced ultrasound (CEUS) biomarkers in ovarian cancer based on unique ability of CEUS to detect malignant neovascularity: addressing long-standing concern of variability of CEUS imaging by evaluating CEUS biomarkers reproducibility with consecutive injections and CEUS inter-reader reliability across blinded experts. The main technical innovation is the development of an innovative CEUS Quantitative Statistical Features to further improve categorization of indeterminate ovarian/adnexal lesions. Once properly validated, CEUS is expected to improve patient outcomes by offering a viable tool for ovarian/adnexal lesion characterization, enabling earlier and more precise diagnosis of malignancy in our patients. Current imaging modalities for evaluating ovarian lesions include endovaginal ultrasound (EVUS) and contrast-enhanced magnetic resonance imaging (MRI), with lesion categorization guided by the American College of Radiology (ACR) Ovarian-Adnexal Reporting and Data System (O-RADS) providing 75% sensitivity and 92% specificity for ovarian cancer (2). In the majority of cases, lesions are classified as benign (O-RADS 1, 2), nonetheless, a substantial proportion fall into indeterminate or suspicious categories (O-RADS 3, 4, 5), often requiring additional imaging follow-up or surgical excision for definitive characterization. The subject population will include patients with indeterminate or suspicious ovarian/adnexal lesions detected with ultrasound (US) (O-RADS US 3-5) or contrast-enhanced MRI (O-RADS MRI 3-5) performed as part of their clinical standard of care. Patients will first undergo baseline transabdominal and transvaginal US imaging. B-mode measurements and sweeps of the ovarian/adnexal lesion in the transverse and sagittal planes will be acquired. Color Doppler images will be acquired to assess lesion vascularity. Following baseline imaging, patients will receive a bolus IV injection of US contrast, followed by a normal saline flush. The US contrast agent will be administered by bolus intravenous injection through a 18-22 Gauge angiocatheter placed in a peripheral arm vein ultrasound contrast agent, as per manufacturer's guidelines. During a single examination, a second injection will be administered, and imaging repeated using the same or different transducer. During the contrast injection the approximate lesion mid-line or the most vascular portion of the lesion will be imaged until homogenous enhancement is achieved (approximately 30-60 seconds post injection), followed by imaging sweeps through the lesion.. After that, intermittent imaging will be continued for 3 minutes, after which data will be digitally stored for later review. Primary: • To evaluate the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of qualitative CEUS biomarkers for diagnosing ovarian cancer. Secondary: * To evaluate the reproducibility and inter-reader reliability of qualitative CEUS biomarkers for ovarian cancer diagnosis. * To prospectively evaluate the diagnostic performance of a multimodal model for ovarian cancer diagnosis.

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