Actively Recruiting
The Efficacy and Safety of FRD001 in Ultrasound Contrast Imaging for Malignant Ovarian Masses in Women
Led by Tongji Hospital · Updated on 2024-08-16
198
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
T
Tongji Hospital
Lead Sponsor
P
Peking University People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Efficacy and Safety of FRD001 in Ultrasound Contrast Imaging for Malignant Ovarian Masses in Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 to 75 years (inclusive)
- Patients with untreated unilateral or bilateral, unilocular or multilocular cystic or solid ovarian masses
- Expected survival of at least 3 months
- ECOG performance status of 0 to 2 for participants with malignant tumors
- Adequate organ function including hematology, liver, kidney, coagulation, electrolytes, cardiac function, and pulse oximetry as specified
- Women of childbearing potential must use effective contraception during the study
- Ability to understand and voluntarily consent to the study and adhere to protocol requirements
You will not qualify if you...
- Patients with benign teratomas
- Patients who have had total removal of the uterine appendages
- Patients with congenital malformations of the reproductive system
- Patients who received radiotherapy, chemotherapy, or invasive procedures during investigational drug administration and confirmatory diagnosis
- Women pregnant, breastfeeding, planning pregnancy within 6 months, or with positive pregnancy test during screening
- Allergy to FRD001 components or history of severe allergies
- Insufficient acoustic window for ultrasound examination
- Contraindications for imaging examinations per protocol
- Conditions such as adult respiratory distress syndrome, severe emphysema, pulmonary vasculitis, or pulmonary embolism
- Severe cardiovascular or cerebrovascular diseases including significant arrhythmias, recent acute events, or low heart function
- Known severe pulmonary hypertension or uncontrolled systemic hypertension
- Symptomatic brain metastases requiring treatment
- Severe or uncontrolled mental illness
- Active infections needing systemic treatment or uncontrolled infections within 14 days prior to investigational drug start
- Positive tests for HIV, HCV, syphilis, or hepatitis B surface antigen
- History of right-to-left or bidirectional cardiac shunts
- History of alcohol or drug abuse/dependence
- Participation in other investigational drug trials within 30 days prior to screening
- Medications or treatments that may interfere with trial data or cause severe side effects not washed out
- Any other conditions judged inappropriate for study participation by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
Q
Qinglei Gao, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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