NCT03297112

Contrast-Enhanced Subharmonic Ultrasound Imaging in Improving Characterization of Adnexal Masses in Patients Undergoing Surgery

Subharmonic Contrast Ultrasound for Improved Characterization for Adnexal Masses-A Pilot Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Adnexal Mass

Interventions

Type	Name	Description
DRUG	Perflutren Lipid Microspheres	Given IV
PROCEDURE	Contrast-Enhanced Subharmonic Ultrasound Imaging	Undergo contrast-enhanced subharmonic ultrasound imaging

Timeline

• Start date: 2017-08-01
• Primary completion: 2018-09-04
• Completion: 2018-09-04
• First posted: 2017-09-29
• Last updated: 2025-05-15
• Results posted: 2019-09-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study