Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06556342
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-11
Brief Title:
The Efficacy and Safety of FRD001 in Ultrasound Contrast Imaging for Malignant Ovarian Masses in Women
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of FRD001 Injection in Ultrasound Contrast Imaging for the Differential Diagnosis of Benign and Malignant Ovarian Masses in Women
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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-scalepower 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-scalepower 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 005 with a power 1-β of 80 and an inconsistency ratio D of 034 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None