Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
With
National Institutes of Health (NIH)
Lantheus Medical Imaging
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.
Age
21–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Patients with respiratory distress syndrome
Patients with thrombosis within the splenic vein
Clareo Health | Contrast-Enhanced Subharmonic Ultrasound Imaging in Improving Characterization of Adnexal Masses in Patients Undergoing Surgery
