Cerebrovascular Disorders Clinical Trial
— FluoesceinOfficial title:
Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions
This study focuses on implementing Yellow 560 for the direct intraoperative visualization of Fluorescein Sodium stained intracranial lesions to facilitate extend of surgery, develop better treatment protocols, and improve the prognosis of a wide array of neurosurgical diseases. More specifically, for the patients who are undergoing surgical intervention for the treatment of their brain aneurysm, tumor, arteriovenous malformation or fistula, the investigators will inject the dye intraoperatively to assess for residual aneurysm, tumor or in general residual lesion which must be corrected.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | April 2019 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult patients (age = 18) - Diagnosed by preoperative imaging modalities to have a brain tumor (including metastatic brain tumors) or vascular lesions (aneurysm, arteriovenous malformation or arteriovenous fistula) requiring surgical intervention. - The patient is determined by a board certified neurosurgeon to have a tumor or vascular lesion that would take up fluorescein - Patient or legally authorized representative provides written informed consent to enroll in this study |
Country | Name | City | State |
---|---|---|---|
United States | Florida Hospital | Orlando | Florida |
Lead Sponsor | Collaborator |
---|---|
Florida Hospital |
United States,
1. Ciardella AP, Kaufman SR, Yannuzzi LA. The use of fluorescein angiography in acquired macular diseases. In: Tasman W, Jaeger EA, eds. Foundations of Clinical Ophthalmology. 15th ed. Philadelphia, Pa: Lippincott Williams & Wilkins; 2009:chap 113F.
2. Dithmar, Stefan, Holz, Frank G. Fluorescence Angiography in Ophthalmology. 2008, X, 224 p. 541 illus. in color.
3. Maguire JI, Federman JL. Intravenous fluorescein angiography. In: Tasman W, Jaeger EA, eds. Duane's Ophthalmology. 15th ed. Philadelphia, Pa: Lippincott Williams & Wilkins; 2009:chap 44.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Intracerebral lesion | The main outcome measure of the study would be a comparison between patient pre-operative and post-operative images to evaluate the potential utility of using Fluorescein Sodium and the Yellow 560 microscope to aid in the treatment of intracranial tumors and vascular lesions. | Particpants will be followed from enrollment into study which include atleast to 2 images and any other image done up to 1 year of scheudled follow up. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03239847 -
Cost Effectiveness of the EndoPhys Pressure Sensing Access System vs. Radial A-line for Intra-operative Blood Pressure Monitoring
|
N/A | |
Recruiting |
NCT03544801 -
Renji Cerebral Small Vessel Disease Corhort Study
|
||
Recruiting |
NCT06010823 -
Safety and Efficacy Evaluation of the Robotic Enhanced Error Training of Upper Limb Function in Post-stroke and Post TBI Participants
|
N/A | |
Withdrawn |
NCT04991038 -
Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients
|
N/A | |
Recruiting |
NCT02472028 -
Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals
|
Phase 4 | |
Completed |
NCT01915368 -
Determining Optimal Post-Stroke Exercise (DOSE)
|
N/A | |
Active, not recruiting |
NCT01555411 -
Akershus Cardiac Examination (ACE) 1950 Study
|
||
Completed |
NCT01304576 -
Orientation Agnosia: Clinical and Anatomical Study
|
N/A | |
Completed |
NCT00059293 -
Transcranial Doppler (TCD) Ultrasound of Subjects Enrolled in BABY HUG - Ancillary to BABY HUG
|
||
Completed |
NCT00049920 -
The ARIC MRI Study
|
N/A | |
Completed |
NCT00049894 -
Predictors of Recurrent Stroke in the PROGRESS Study
|
N/A | |
Completed |
NCT00005562 -
Coronary Artery Calcium, Exercise Tests, and CHD Outcome
|
N/A | |
Completed |
NCT00005395 -
Honolulu Heart Program-Study of Stroke and Dementia
|
N/A | |
Completed |
NCT00000479 -
Women's Health Study (WHS): A Randomized Trial of Low-dose Aspirin and Vitamin E in the Primary Prevention of Cardiovascular Disease and Cancer
|
Phase 3 | |
Completed |
NCT00005140 -
Epidemiology of Cardiovascular and Non-Cardiovascular Risk In Chicago
|
N/A | |
Enrolling by invitation |
NCT00005485 -
The Jackson Heart Study of Cardiovascular Disease Among African Americans
|
||
Recruiting |
NCT06275113 -
BRING-UP Prevention
|
||
Completed |
NCT02702635 -
Measuring Blood Flow Characteristics Using Dynamic Contrast Enhanced Magnetic Resonance Imaging
|
N/A | |
Recruiting |
NCT04336852 -
Development of a Clinically-relevant Test for Assessment of Cerebral Vascular Function
|
N/A | |
Not yet recruiting |
NCT05892510 -
Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke
|
Phase 2/Phase 3 |