Clinical trial · Observational
Definity for Ultrasound of Intraocular Tumors
Use of Definity® Contrast Agent for Ultrasound of Intraocular Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study did not receive funding to move forward
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ocular Melanoma | Ocular Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Ultrasound measurement
- description
- 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.
Primary outcomes (1)
- measure
- Quantification of tumor perfusion and visualization of microvasculature using ultrasound enhanced images of intraocular tumors with microbubbles
- timeFrame
- Up to 2 years
- description
- 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 outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available