Definity for Ultrasound of Intraocular Tumors

Withdrawn

• Conditions: Ocular Melanoma

• Registration Number: NCT01930968
• Lead Sponsor: Emory University

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.

Study Timeline

• Study First Submitted: 2013-02-28
• Study First Submitted QC: 2013-08-26
• Study First Posted: 2013-08-29
• Status Verified: 2022-02
• Study Start: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-23
• Primary Completion: 2022-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adults 20 years old or over 18 years old with large uveal melanoma who are going to undergo enucleation

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantification of tumor perfusion and visualization of microvasculature using ultrasound enhanced images of intraocular tumors with microbubbles	Up to 2 years	Ultrasound will be used to acoustically identify microbubbles in vascular channels in the intraocular tumors, including uveal melanoma, metastases and retinal tumors. Blood vessels in the tumor and retina are identified after IV injection of Definity® microbubbles which is used as the ultrasound contrast agent.

Secondary Outcome Measures

Name	Time	Method
Correlation between tumor vascularity by contrast enhanced ultrasoungraphy and histologically determined tumor vascular density	Up to 2 years	The uptake of the Definity® microbubbles by the blood vessels in the tumor as determined by contrast enhanced ultrasoungraphy will be correlated with histologically determined tumor size and mean vascular density.
Correlation between tumor size by contrast enhanced ultrasoungraphy and histologically determined tumor size	Up to 2 years	The tumor size as determined by contrast enhanced ultrasoungraphy will be correlated with histologically determined tumor size.

Trial Locations

Locations (1)

Emory Eye Center; 🇺🇸 Atlanta, Georgia, United States