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

• Status: Completed
• Trial end date: 2018-09-04
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Collaborators: Lantheus Medical Imaging; National Institutes of Health (NIH)

Criteria

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