Status:
COMPLETED
Contrast-Enhanced Subharmonic Ultrasound Imaging in Improving Characterization of Adnexal Masses in Patients Undergoing Surgery
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborating Sponsors:
National Institutes of Health (NIH)
Lantheus Medical Imaging
Conditions:
Adnexal Mass
Eligibility:
FEMALE
21+ years
Phase:
EARLY_PHASE1
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 ...
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 characterizatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03297112
Start Date
August 1 2017
End Date
September 4 2018
Last Update
May 15 2025
Active Locations (1)
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1
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107