Clinical trial NCT02028325: Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions
Official title: Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Adult Intracranial Neoplasm
Vascular: Intracranial
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Sentara Norfolk General Hospital
First posted: 2014-01-07
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of using Fluorescein Sodium and the Yellow 560 microscope to aid in treatment of intracranial tumors and vascular lesions.

Detailed description: The purpose of this study is to evaluate the effectiveness of using Fluorescein Sodium and the Yellow 560 microscope to aid in treatment of intracranial tumors and vascular lesions. The objectives of this study aim to investigate the use of Fluorescein in assisting with evaluating complete tumor removal and thorough treatment of intracranial vascular lesions as well as tumor biopsy procedures. The hypothesis is that Fluorescein Sodium will help surgeons better identify residual tumor and vascular lesions and its use will allow surgeons to obtain better surgical results and prognostic outcomes.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older.
* Diagnosed by preoperative imaging modalities to have a brain tumor or vascular lesions (aneurysm, arteriovenous malformation or arteriovenous fistula) requiring surgical intervention.
* The patient is determined by a board certified Neurosurgeon (above mentioned neurosurgeons) to benefit from the application of Fluorescein Sodium intraoperatively
* Patient or legally authorized representative provides written informed consent to enroll in this study.

Exclusion Criteria:

* Known allergic reaction to Fluorescein Sodium.
* Children.
* Prisoners.
* Students.
* Infection of the central nervous system or other sites.
* Hemodynamic instability or significant impairments in circulation.
* Concomitant treatment with other investigational drugs.
* Any uncontrolled condition unrelated to the neurosurgical disease.
* History of psychiatric, additive, or any other disorder that compromises the ability to provide informed consent or comply with study protocols.
* Participation on other clinical trials during the last thirty days.
* Pregnant patients.
* Patients unable to discontinue medications that affect Fluorescein metabolism.

Primary outcomes:
measure: Concordance Between Surgical Impression of Residual Lesion and Appearance on Post-operative Imaging
timeFrame: up to 1 week. For subjects where clinical post-operative MRI/angiography was not performed within 7 days, MRI/angiography completed within 3 months post-operatively was utilized for evaluation.
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Aaron Cohen-Gadol, MD
state: Indiana
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
Study officials:
affiliation: IU Health Methodist Hospital
name: Aaron A Cohen, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: