Recruiting

Observational Study

Sponsor:

AdventHealth

Code:

NCT02478346

Conditions

Cerebrovascular Disorders

Intracranial Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fluorescein Sodium

Study Details

Brief 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.

Conditions

Cerebrovascular Disorders

Intracranial Neoplasms

Study ID

NCT02478346

Start date

May, 2015

Status verified date

Feb, 2017

Completion date

Apr, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: All Patients

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).

Interventions

Fluorescein Sodium

Conventional microsurgical and biopsy procedures and techniques including histopathology and intraoperative imaging will be performed through the completion of the surgery. The surgeon will resect and remove what he believes is the tumor based on previously known criteria (standards of care) regardless of what the Fluorescein angiography demonstrates. For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.

Primary outcome measure

  • Incidence of Intracerebral lesion [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Cherlynn Basignani, BSN,RN,CCRC

407-303-3247cherlynn.basignani@flhosp.org

Gabriella Anderson, BA, CCRC

407-303-3214gabriella.anderson@flhosp.org

Locations

Florida Hospital

Recruiting

Orlando, Florida, United States, 32804

More Information

Sponsor

AdventHealth

Last update posted

Feb 14, 2017

Last verified

Feb, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AdventHealth on 2017-02-14.