This is a Prospective, Self-Controlled, Open-Label, Multicenter Clinical Trial. The purpose of this study is to demonstrate the efficacy and safety of FRD001 injection in ultrasound contrast imaging for the differentiation between benign and malignant ovarian masses in women, using gray-scale and power Doppler ultrasound as controls. This trial will adopt a self-controlled design, where each participant will first undergo gray-scale/power Doppler ultrasound imaging, followed by FRD001 injection-enhanced ultrasound imaging. The target population is assumed to have a malignancy prevalence (P) of 40%, with an expected sensitivity of gray-scale/power Doppler ultrasound at 70%. It is hypothesized that the sensitivity of FRD001 injection-enhanced ultrasound will improve by 20%, reaching an anticipated sensitivity of 90%. The significance level (α) is set at 0.05, with a power (1-β) of 80%, and an inconsistency ratio (D) of 0.34. Based on these parameters, a total sample size (N) of 178 cases is required. Considering a 10% dropout rate, at least 198 subjects will be needed, which includes 79 participants with malignant tumors (N1) and 119 with benign conditions (N2). All screening assessments for each participant will be conducted within 7 days prior to the administration of the investigational medicinal product (IMP), including the day of administration. Safety observations will continue for 72 ± 24 hours post-IMP administration. Pathological results for the target lesions will be collected within 30 days following the IMP imaging examination. The efficacy of the IMP in differentiating between benign and malignant ovarian masses will be evaluated against pathological results, which will serve as the gold standard. This comprehensive approach will provide crucial insights into the diagnostic capabilities of FRD001 injection, potentially enhancing clinical decision-making in the management of ovarian masses.
Female participants aged 18 to 75 years (inclusive of the age limits);
Patients with untreated unilateral or bilateral, unilocular or multilocular cystic/solid masses;
Expected survival of at least 3 months;
ECOG performance status of 0 to 2 for participants with malignant tumors;
Patients with benign teratomas;
Patients who have undergone total removal of the uterine appendages;
Patients with congenital malformations of the reproductive system;
Patients who have received radiotherapy, chemotherapy, or invasive procedures (including but not limited to radiofrequency ablation) during the administration of the investigational medicinal product (IMP) and the confirmatory diagnostic examination;
Single group
FRD001
DrugFRD001 injection is a lipid-based second-generation ultrasound contrast agent. FRD001 injection in ultrasound contrast imaging could enhance the differentiation between benign and malignant ovarian masses in women, using gray-scale and power Doppler ultrasound as controls.
Sensitivity
The primary endpoint is sensitivity, calculated using pathological results as the gold standard, according to the previously established formulas.
Specificity
The secondary endpoints include specificity, calculated using pathological results as the gold standard, according to the previously established formulas.
Adverse events (AE) and serious adverse events (SAE)
Adverse events (AE) and serious adverse events (SAE) are assessed according to the common terminology criteria for adverse events (NCI-CTCAE) version 5.0. All adverse events occurring in subjects during the clinical trial are observed, and their clinical characteristics, severity, occurrence time, resolution time, management measures, and outcomes are recorded, along with an assessment of their correlation with the investigational drug.
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Tongji Hospital
Lead sponsor
Peking University People's Hospital
Collaborator
