Trial Outcomes & Findings for Contrast-Enhanced Subharmonic Ultrasound Imaging in Improving Characterization of Adnexal Masses in Patients Undergoing Surgery (NCT NCT03297112)

Last Updated: 2025-05-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

12 participants

Primary outcome timeframe

Baseline scan to day of surgery

Results posted on

2025-05-15

Participant Flow

Participant milestones

Participant milestones
Measure	Contrast-enhanced Subharmonic Ultrasound Imaging 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. Perflutren Lipid Microspheres: Given IV Contrast-Enhanced Subharmonic Ultrasound Imaging: Undergo contrast-enhanced subharmonic ultrasound imaging
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Contrast-enhanced Subharmonic Ultrasound Imaging n=12 Participants 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. Perflutren Lipid Microspheres: Given IV Contrast-Enhanced Subharmonic Ultrasound Imaging: Undergo contrast-enhanced subharmonic ultrasound imaging
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline scan to day of surgery

Outcome measures

Outcome measures
Measure	Contrast-enhanced Subharmonic Ultrasound Imaging n=12 lesions 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. Perflutren Lipid Microspheres: Given IV Contrast-Enhanced Subharmonic Ultrasound Imaging: Undergo contrast-enhanced subharmonic ultrasound imaging
Diagnostic Accuracy of Subharmonic Ultrasound Imaging Compared to Standard Ultrasound or Contrast Enhanced Magnetic Resonance Imaging (MRI) Qualitative analysis of CEUS SHI with contrast	70 percent accurate lesion identification
Diagnostic Accuracy of Subharmonic Ultrasound Imaging Compared to Standard Ultrasound or Contrast Enhanced Magnetic Resonance Imaging (MRI) Qualitative analysis of CEUS SHI without contrast	56 percent accurate lesion identification

PRIMARY outcome

Timeframe: Baseline scan to day of surgery

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.

Outcome measures

Outcome measures
Measure	Contrast-enhanced Subharmonic Ultrasound Imaging n=12 Participants 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. Perflutren Lipid Microspheres: Given IV Contrast-Enhanced Subharmonic Ultrasound Imaging: Undergo contrast-enhanced subharmonic ultrasound imaging
Accuracy of SHI Characterization Compared to the Risk of Malignancy Index	73 percent accurate m lesion identification

Adverse Events

Contrast-enhanced Subharmonic Ultrasound Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Flemming Forsberg, PhD

Sidney Kimmel Cancer Center at Thomas Jefferson University

Phone: 215-955-4870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place