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Clinical Trial Summary

This pilot clinical trial studies how well contrast-enhanced subharmonic ultrasound imaging works in improving the characterization of adnexal masses in patients undergoing surgery. Contrast-enhanced subharmonic ultrasound imaging uses high-frequency sound waves to produce images of internal organs and when combined with an ultrasound agent such as perflutren lipid microspheres, may help improve imaging and management of adnexal masses.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To develop qualitative subharmonic imaging (SHI) or SHI-derived quantitative biomarkers. II. To generate pilot data for a study to evaluate if they improve the characterization of benign and malignant adnexal masses compared to standard ultrasound or contrast enhanced magnetic resonance imaging (MRI) or the risk of malignancy index (RMI). SECONDARY OBJECTIVES: I. To compare the SHI depiction of adnexal masses' neovascularity in humans to intra-tumoral microvascular density (iMVD) obtained from CD31 an immunohistochemical marker of angiogenesis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03297112
Study type Interventional
Source Thomas Jefferson University
Contact
Status Completed
Phase Early Phase 1
Start date August 1, 2017
Completion date September 4, 2018

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