Definity for Ultrasound of Intraocular Tumors
Status: | Recruiting |
---|---|
Conditions: | Skin Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 20 - Any |
Updated: | 3/8/2019 |
Start Date: | July 2019 |
End Date: | December 2019 |
Contact: | Hans E Grossniklaus, MD |
Email: | ophtheg@emory.edu |
Phone: | 404-778-4611 |
Use of Definity® Contrast Agent for Ultrasound of Intraocular Tumors
The study will test the usefulness of a contrast agent to help image tumors in the eye. In
this study, patients with eye melanoma who are going to have their eye removed, will have
their eye imaged by ultrasound (sound waves) before and after intravenous injection of
microbubbles. The pathology characteristics of the tumor in the removed eye will be compared
with the images.
this study, patients with eye melanoma who are going to have their eye removed, will have
their eye imaged by ultrasound (sound waves) before and after intravenous injection of
microbubbles. The pathology characteristics of the tumor in the removed eye will be compared
with the images.
The investigators plan to enroll and image 10 patients with intraocular tumors who are going
to undergo enucleation of their eye for the tumor. Definity®, a perflutren containing
microsphere manufactured by Lantheus Medical Imaging, Inc., is commercially available and FDA
approved for cardiac imaging. It is contraindicated for use in patients with pulmonary
hypertension, unstable cardiopulmonary conditions, and cardiac shunts (right-to-left,
bi-directional, or transient right-to left). After informed consent is obtained, a
cardiologist will examine the patient's history, perform lung and heart auscultation, and
obtain a blood pressure in order to ensure the patient has no contraindications to using
Definity®. If there are no contraindications, routine ocular ultrasonography, both A and B
scans, will be performed using an Ellex Eye Cubed ultrasound machine. Definity® will be
prepared per package instructions and the appropriate dose will be calculated. If necessary,
a second 10 microliter/kg dose may be give 30 minutes after the first IV injection. A bubble
test (intravenous small amount of Definity injected with cardiac echo) will be performed in
the cardiology imaging suite, clinical building A, in order to ensure that the patient does
not have a right to left shunt. After that, Definity® will be administered as a slow IV bolus
followed by a normal saline 10cc flush. The ultrasonographer will continue the ocular B scan
during administration of Definity®. Vital signs will be obtained and documented at 30 minutes
after administration of the last dose of Definity® and longer if needed.
to undergo enucleation of their eye for the tumor. Definity®, a perflutren containing
microsphere manufactured by Lantheus Medical Imaging, Inc., is commercially available and FDA
approved for cardiac imaging. It is contraindicated for use in patients with pulmonary
hypertension, unstable cardiopulmonary conditions, and cardiac shunts (right-to-left,
bi-directional, or transient right-to left). After informed consent is obtained, a
cardiologist will examine the patient's history, perform lung and heart auscultation, and
obtain a blood pressure in order to ensure the patient has no contraindications to using
Definity®. If there are no contraindications, routine ocular ultrasonography, both A and B
scans, will be performed using an Ellex Eye Cubed ultrasound machine. Definity® will be
prepared per package instructions and the appropriate dose will be calculated. If necessary,
a second 10 microliter/kg dose may be give 30 minutes after the first IV injection. A bubble
test (intravenous small amount of Definity injected with cardiac echo) will be performed in
the cardiology imaging suite, clinical building A, in order to ensure that the patient does
not have a right to left shunt. After that, Definity® will be administered as a slow IV bolus
followed by a normal saline 10cc flush. The ultrasonographer will continue the ocular B scan
during administration of Definity®. Vital signs will be obtained and documented at 30 minutes
after administration of the last dose of Definity® and longer if needed.
Inclusion Criteria:
- Adults 20 years old or over 18 years old with large uveal melanoma who are going to
undergo enucleation
Exclusion Criteria:
- Patient with right-to-left, bi-direction, or transient right-to-left cardiac shunts
- Worsening of or clinically unstable congestive heart failure
- Acute myocardial infarctions or acute coronary syndromes
- Serious ventricular arrhythmias or high risk for arrhythmias, due to prolongation of
the QT-interval (>60 msec)
- Respiratory failures marked by signs and symptoms of CO2 retention or hypoxemia
- Severe emphysema, pulmonary emboli, or other conditions that cause pulmonary
hypertension due to compromised pulmonary-arterial vasculature
- Known hypersensitivity to perflutren (if the patient has been exposed to perflutren in
the past and had an allergic reaction)
- Pregnancy or nursing mothers
We found this trial at
1
site
Atlanta, Georgia 30322
Principal Investigator: Hans E Grossniklaus, MD
Phone: 404-778-2421
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