Adnexal Mass
Conditions
Brief 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.
Interventions
Given IV
PROCEDUREContrast-Enhanced Subharmonic Ultrasound Imaging
Undergo contrast-enhanced subharmonic ultrasound imaging
Sponsors
National Institutes of Health (NIH)
Lantheus Medical Imaging
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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 Institutional Review Board (IRB)-approved informed consent form for participating in the study
Exclusion criteria
* Females who are pregnant or nursing * Patients who have received an investigational drug in the 30 days before study drug administration, or will receive one within 72 hours (h) afterwards * Patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts * Patients with pulmonary hypertension or unstable cardiopulmonary conditions * Patients currently on chemotherapy or with other primary cancers requiring systemic or hepatic loco-regional treatment * Patients who are clinically unstable, patients who are seriously or terminally ill with a life expectancy of less than 1 month, and patients whose clinical course are unpredictable; for example: * Patients on life support or in a critical care unit * Patients with unstable occlusive disease (e.g., crescendo angina) * Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia * Patients with uncontrolled congestive heart failure (New York Heart Association \[NYHA\] class IV) * Patients with recent cerebral hemorrhage * Patients who have undergone surgery within 24 hours prior to the study sonographic examination * Patients with a history of anaphylactic allergy to Definity, manifested by one or more of the following symptoms: generalized urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock * Patients with congenital heart defects * Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli * Patients with respiratory distress syndrome * Patients with thrombosis within the splenic vein
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Accuracy of Subharmonic Ultrasound Imaging Compared to Standard Ultrasound or Contrast Enhanced Magnetic Resonance Imaging (MRI) | Baseline scan to day of surgery | 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. |
| Accuracy of SHI Characterization Compared to the Risk of Malignancy Index | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Contrast-enhanced Subharmonic Ultrasound Imaging |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Accuracy of SHI Characterization Compared to the Risk of Malignancy Index
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.
Time frame: Baseline scan to day of surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contrast-enhanced Subharmonic Ultrasound Imaging | Accuracy of SHI Characterization Compared to the Risk of Malignancy Index | 73 percent accurate m lesion identification |
Primary
Diagnostic Accuracy of Subharmonic Ultrasound Imaging Compared to Standard Ultrasound or Contrast Enhanced Magnetic Resonance Imaging (MRI)
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.
Time frame: Baseline scan to day of surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 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 |
| 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 without contrast | 56 percent accurate lesion identification |