Using FRD001 to improve ultrasound imaging for ovarian cancer detection

Efficacy and Safety of FRD001 Injection in Ultrasound Contrast Imaging for the Differential Diagnosis of Benign and Malignant Ovarian Masses in Women

This study is testing if an injection called FRD001 can make ultrasound imaging better at telling the difference between harmless and cancerous ovarian growths in women.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 198 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Tongji Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06556342 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of FRD001 injection in enhancing ultrasound contrast imaging for differentiating between benign and malignant ovarian masses in women. Participants will first undergo standard gray-scale and power Doppler ultrasound imaging, followed by FRD001 injection-enhanced imaging. The study is designed as a prospective, self-controlled, open-label, multicenter trial, with an expected sample size of 178 cases. The trial hypothesizes that the sensitivity of the enhanced imaging will significantly improve compared to standard methods.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 75 with untreated ovarian masses who meet specific health criteria.

Not a fit: Patients with benign ovarian masses or those who do not meet the health criteria for participation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate differentiation of malignant ovarian masses, improving patient outcomes and treatment decisions.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in enhancing imaging techniques for cancer detection.

Eligibility criteria

Inclusion Criteria:

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 Criteria:

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.

Where this trial is running

Wuhan, Hubei

• Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Study coordinator: Qinglei Gao, PhD

Conditions: Ovary Cancer