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1. Use of Definity® Contrast Agent for Ultrasound of Intraocular Tumors

Status
Temporarily Closed
Cancer Type
Eye Cancer
Trial Phase
Eligibility
18 and over, Male and Female
Study Type
Diagnostic
NCD ID
NCT01930968
Protocol IDs
IRB0003943 (primary)
Study Sponsor
Winship Cancer Institute of Emory University

Summary

The hypothesis is that microbubbles may be used as 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.

Objectives

We plan to enroll and image 10 patients with intraocular tumors who are going to undergo enucleation of their eye for the tumor. Definity®, a perlutren contaning 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 in the 3rd floor ultrasound suite at the Emory Eye Center using an Ellex Eye Cubed ultrasound machine. Definity® will be prepared per package instructions. A physician will obtain the patient's weight and calculate the dose according to the following formula:

  • Patient weight (kg) X 10 microliters = Definity® dose
  • 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 as the patient's condition warrants.
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