Definity for Ultrasound of Intraocular Tumors

NCT ID: NCT01930968

Last Updated: 2022-02-23

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2022-06-30

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.

Conditions

Ocular Melanoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Ultrasound measurement

There is only 1 arm in this study. The ocular tumors will be imaged using ultrasound and the contrast agent. The patient's history will be noted, lung and heart auscultation will be performed, and blood pressure readings will be obtained 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® (the microbubble contrast agent) will be prepared per package instruction and the dose calculated according to the following formula: Patient weight (kg) X 10 microliters = Definity® dose. If necessary, a second 10 microliter/kg dose may be given 30 minutes after the first IV injection.

No interventions assigned to this group

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Hans Grossniklaus, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Emory Eye Center

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00039493

Identifier Type: -

Identifier Source: org_study_id