Definity for Ultrasound of Intraocular Tumors

NCT01930968 | Withdrawn DMC

• 1 other identifier: IRB00039493
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Ocular Melanoma

Keywords

Uveal melanoma, ocular melanoma

Outcome Measures

Primary Outcomes (1)

• Quantification of tumor perfusion and visualization of microvasculature using ultrasound enhanced images of intraocular tumors with microbubbles

  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.

  Up to 2 years

Secondary Outcomes (2)

• Correlation between tumor vascularity by contrast enhanced ultrasoungraphy and histologically determined tumor vascular density

  Up to 2 years

• Correlation between tumor size by contrast enhanced ultrasoungraphy and histologically determined tumor size

  Up to 2 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory Eye Center

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Uveal Melanoma

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 28, 2013
• First Posted: August 29, 2013
• Study Start: February 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)