Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-29 @ 10:59 AM
Study NCT ID:
NCT01930968
Status:
WITHDRAWN
Last Update Posted:
2022-02-23
First Post:
2013-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Definity for Ultrasound of Intraocular Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098943', 'term': 'Uveal Melanoma'}], 'ancestors': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D014604', 'term': 'Uveal Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Study did not receive funding to move forward', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-07', 'studyFirstSubmitDate': '2013-02-28', 'studyFirstSubmitQcDate': '2013-08-26', 'lastUpdatePostDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.'}], 'secondaryOutcomes': [{'measure': 'Correlation between tumor vascularity by contrast enhanced ultrasoungraphy and histologically determined tumor vascular density', 'timeFrame': 'Up to 2 years', 'description': '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.'}, {'measure': 'Correlation between tumor size by contrast enhanced ultrasoungraphy and histologically determined tumor size', 'timeFrame': 'Up to 2 years', 'description': 'The tumor size as determined by contrast enhanced ultrasoungraphy will be correlated with histologically determined tumor size.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Uveal melanoma, ocular melanoma'], 'conditions': ['Ocular Melanoma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 20 years old or over 18 years old with large uveal melanoma who are going to undergo enucleation\n\nExclusion Criteria:\n\n* Patient with right-to-left, bi-direction, or transient right-to-left cardiac shunts\n* Worsening of or clinically unstable congestive heart failure\n* Acute myocardial infarctions or acute coronary syndromes\n* Serious ventricular arrhythmias or high risk for arrhythmias, due to prolongation of the QT-interval (\\>60 msec)\n* Respiratory failures marked by signs and symptoms of CO2 retention or hypoxemia\n* Severe emphysema, pulmonary emboli, or other conditions that cause pulmonary hypertension due to compromised pulmonary-arterial vasculature\n* Known hypersensitivity to perflutren (if the patient has been exposed to perflutren in the past and had an allergic reaction)\n* Pregnancy or nursing mothers'}, 'identificationModule': {'nctId': 'NCT01930968', 'briefTitle': 'Definity for Ultrasound of Intraocular Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Use of Definity® Contrast Agent for Ultrasound of Intraocular Tumors', 'orgStudyIdInfo': {'id': 'IRB00039493'}}, 'armsInterventionsModule': {'armGroups': [{'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."}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Eye Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Once research is completed, results of the study will be published in a specialty journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hans Grossniklaus, MD', 'investigatorAffiliation': 'Emory University'}}}}