Clinical trial NCT01930968: Definity for Ultrasound of Intraocular Tumors
Official title: Use of Definity® Contrast Agent for Ultrasound of Intraocular Tumors
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ocular Melanoma
Keywords: Uveal melanoma, ocular melanoma
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2013-08-29
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults over 20 years old with intraocular tumors (melanoma, metastasis, retinal tumors) who are going to undergo enucleation diagnosed in the Emory Eye Center Ocular Oncology Service. Patients will be assessed by a cardiologist or cardiology fellows.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quantification of tumor perfusion and visualization of microvasculature using ultrasound enhanced images of intraocular tumors with microbubbles
timeFrame: Up to 2 years
Secondary outcomes:
measure: Correlation between tumor vascularity by contrast enhanced ultrasoungraphy and histologically determined tumor vascular density
timeFrame: Up to 2 years
measure: Correlation between tumor size by contrast enhanced ultrasoungraphy and histologically determined tumor size
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Eye Center
state: Georgia
Study officials:
References: