The Efficacy and Safety of FRD001 in Ultrasound Contrast Imaging for Malignant Ovarian Masses in Women

Prior treatment

• 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;
• Insufficient acoustic window indicated by ultrasound examination during screening or prior examinations;
• Presence of active infections requiring systemic treatment or uncontrolled infections within 14 days prior to starting the investigational drug;
• Participation in other clinical trials involving investigational drugs within 30 days prior to screening;
• Any medications or treatments deemed by the investigator to potentially interfere with trial data or cause severe side effects that have not been fully washed out prior to enrollment;

Other illness

• Individuals allergic to the components of FRD001 injection or with a history of other severe allergies;
• Conditions such as adult respiratory distress syndrome, severe emphysema, pulmonary vasculitis, or pulmonary embolism;
• Individuals with severe or uncontrolled mental illness;
• Positive tests for antibodies to human immunodeficiency virus (HIV), hepatitis C virus (HCV), or Treponema pallidum; positive hepatitis B virus (HBV) surface antigen;
• History of right-to-left, bidirectional, or transient right-to-left cardiac shunts;
• History of alcohol or drug abuse/dependence;
• Any other conditions deemed inappropriate for participation in this clinical trial by the investigator.

Lab values

• Severe cardiovascular or cerebrovascular diseases, including but not limited to: a. Significant cardiac rhythm or conduction abnormalities that require clinical intervention, such as ventricular arrhythmias, second- to third-degree atrioventricular block, or QTc interval ≥ 450 ms; b. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other cardiovascular events of grade 3 or higher within 6 months prior to the first dose; c. New York Heart Association (NYHA) functional classification ≥ II or left ventricular ejection fraction (LVEF) \< 50%;

Age

• Known severe pulmonary hypertension or uncontrolled systemic hypertension; uncontrolled hypertension (for individuals \<60 years old, systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg; for individuals ≥ 60 years old, systolic blood pressure ≥ 150 mmHg and diastolic blood pressure ≥ 90 mmHg);

Other

• Participants who meet any of the following criteria are not eligible for enrollment:
• Patients with benign teratomas;
• Patients who have undergone total removal of the uterine appendages;
• Patients with congenital malformations of the reproductive system;
• Women planning to become pregnant within 6 months, currently pregnant, or breastfeeding, or women of childbearing potential with a positive pregnancy test during the screening period;
• Presence of contraindications for imaging examinations related to the study protocol;
• Patients with symptomatic brain metastases requiring treatment;

• All participants must meet the following inclusion criteria to be eligible for enrollment in this study:
• 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;
• Organ function levels must meet the following requirements: a. Hematology: WBC ≥ 3 × 10\^9/L, ANC ≥ 1.5 × 10\^9/L, Hb ≥ 90 g/L, PLT ≥ 75 × 10\^9/L; b. Liver function: TBIL ≤ 1.5 × ULN, ALT and AST ≤ 3 × ULN (≤ 5 × ULN for patients with liver metastases); c. Kidney function: Cr ≤ 1.5 × ULN; d. Coagulation function: Prothrombin time (PT) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, International normalized ratio (INR) ≤ 1.5 × ULN; e. Electrolytes: Corrected magnesium ≥ LLN, with allowance for correction of electrolytes during screening; f. Cardiac function: Left ventricular ejection fraction ≥ 50%; g. Pulse oximetry ≥ 93%;
• Women of childbearing potential must use effective contraception during the study (effective contraceptive methods include sterilization, intrauterine hormonal devices, condoms, contraceptive pills/devices, abstinence, or vasectomy);
• Participants must fully understand the purpose, nature, methods, and potential adverse reactions of the trial, voluntarily agree to participate, and sign a written informed consent form, demonstrating the ability to adhere to the protocol requirements to complete the study.