Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03297112 | Contrast-Enhanced Subharmonic Ultrasound Imaging in Improving Characterization of Adnexal Masses in Patients Undergoing Surgery | EARLY_PHASE1 | COMPLETED | 12 | — | — | Aug 1, 2017 | Sep 4, 2018 | May 15, 2025 | 1 | United States |
The techniques will be compared using an analysis of variance (ANOVA) method (i.e., baseline ultrasound imaging, SHI, or MRI) as the dependent variable and outcome as the independent variables. Diagnostic accuracy of lesion identification as "no lesion seen", "definitely benign", "indeterminate" or "definitely malignant" based on independent reads by experience radiologists for SHI with and without contrast vs contrast-enhanced MRI (quantitative analysis). For qualitative analysis, digital images from the SHI imaging were reviewed by the independent radiologists for interpretation. Diagnostic accuracy reported as percentage of lesions correctly identified through SHI as compared to ultrasound or MRI as the gold standard.
The ability of SHI to accurately characterize lesions as benign from malignant masses as compared to other imaging (ultrasound or MRI) and pathology will be analyzed using logistic regression and receiver operating characteristic (ROC) analyses.
| Arm | Type | Description |
|---|---|---|
| contrast-enhanced subharmonic ultrasound imaging | EXPERIMENTAL | Patients receive perflutren lipid microspheres IV. After 15 minutes, patients receive perflutren lipid microspheres IV again over 5 minutes and undergo contrast-enhanced subharmonic ultrasound imaging over 60 minutes. |
| Name | Type | Description |
|---|---|---|
| Perflutren Lipid Microspheres | DRUG | Given IV |
| Contrast-Enhanced Subharmonic Ultrasound Imaging | PROCEDURE | Undergo contrast-enhanced subharmonic ultrasound imaging |
Inclusion Criteria: * Be diagnosed with an adnexal mass * Be scheduled for surgery to remove the adnexal mass * Be clinically stable * If a female of child-bearing potential, must have a negative pregnancy test * Be conscious and able to comply with study procedures * Have read and signed the Insti...