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Subharmonic Contrast Ultrasound for Improved Characterization for Adnexal Masses-A Pilot Study
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.
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.
Age
21 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Start Date
August 1, 2017
Primary Completion Date
September 4, 2018
Completion Date
September 4, 2018
Last Updated
May 15, 2025
12
ACTUAL participants
Perflutren Lipid Microspheres
DRUG
Contrast-Enhanced Subharmonic Ultrasound Imaging
PROCEDURE
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Collaborators
Data Source & Attribution
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