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

NCT03297112 | Completed Early Phase 1 Results DMC FDA Drug

• 3 other identifiers: 16F.394JT 9149R21CA190930
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Adnexal Mass

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline scan to day of surgery

• 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.

  Baseline scan to day of surgery

Study Arms (1)

contrast-enhanced subharmonic ultrasound imaging

EXPERIMENTAL

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.

Drug: Perflutren Lipid Microspheres; Procedure: Contrast-Enhanced Subharmonic Ultrasound Imaging

Interventions

Perflutren Lipid Microspheres DRUG

Given IV

Also known as: Definity

contrast-enhanced subharmonic ultrasound imaging

Contrast-Enhanced Subharmonic Ultrasound Imaging PROCEDURE

Undergo contrast-enhanced subharmonic ultrasound imaging

contrast-enhanced subharmonic ultrasound imaging

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• National Institutes of Health (NIH): collaborator
• Lantheus Medical Imaging: collaborator

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Thomas Jefferson University Hospital

MeSH Terms

Interventions

perflutren

Results Point of Contact

• Title: Flemming Forsberg, PhD
• Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University

flemming.forsberg@jefferson.edu

215-955-4870

Study Officials

• Flemming Forsberg, PhD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Radiology

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 29, 2017
• Study Start: August 1, 2017
• Primary Completion: September 4, 2018
• Study Completion: September 4, 2018
• Last Updated: May 15, 2025
• Results First Posted: September 25, 2019

Record last verified: 2025-05

Locations

US (1)