The Efficacy and Safety of FRD001 in Ultrasound Contrast Imaging for Malignant Ovarian Masses in Women
Recruiting
N/A
Interventional Study
Ovary Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 75
- Sex
- Female
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 198 (estimated)
- Sponsor
- Tongji Hospital · Other
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About This Trial
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 parti…
Trial Locations
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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;
*…
Contacts