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All Patients for Stroke (Fluoescein Trial)

Phase 4
Waitlist Available
Led By Ravi Gandhi, MD
Research Sponsored by AdventHealth
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights

Fluoescein Trial Summary

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.

Eligible Conditions
  • Stroke
  • Brain Tumor

Fluoescein Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Intracerebral lesion

Side effects data

From 2022 Phase 2 trial • 12 Patients • NCT04351373
8%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery

Fluoescein Trial Design

1Treatment groups
Experimental Treatment
Group I: All PatientsExperimental Treatment1 Intervention
All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 500mg (100mg/ml) will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorescein
FDA approved

Find a Location

Who is running the clinical trial?

AdventHealthLead Sponsor
106 Previous Clinical Trials
29,337 Total Patients Enrolled
2 Trials studying Stroke
1,718 Patients Enrolled for Stroke
Ravi Gandhi, MDPrincipal InvestigatorAdventHealth

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions
2015. "Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02478346.
~20 spots leftby Apr 2025
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