Status:
RECRUITING
The Efficacy and Safety of FRD001 in Ultrasound Contrast Imaging for Malignant Ovarian Masses in Women
Lead Sponsor:
Tongji Hospital
Collaborating Sponsors:
Peking University People's Hospital
Conditions:
Ovary Cancer
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
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 f...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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;
- 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;
- Individuals allergic to the components of FRD001 injection or with a history of other severe allergies;
- Insufficient acoustic window indicated by ultrasound examination during screening or prior examinations;
- Presence of contraindications for imaging examinations related to the study protocol;
- Conditions such as adult respiratory distress syndrome, severe emphysema, pulmonary vasculitis, or pulmonary embolism;
- 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%;
- 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);
- Patients with symptomatic brain metastases requiring treatment;
- Individuals with severe or uncontrolled mental illness;
- Presence of active infections requiring systemic treatment or uncontrolled infections within 14 days prior to starting the investigational drug;
- 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;
- 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;
- Any other conditions deemed inappropriate for participation in this clinical trial by the investigator.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT06556342
Start Date
July 1 2024
End Date
July 1 2028
Last Update
August 16 2024
Active Locations (1)
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1
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030