Trials Sponsors Conditions Drugs Pricing

Conditions

Adult Intracranial Neoplasm Vascular: Intracranial

Outcome Measures

Primary Outcomes (1)

Concordance Between Surgical Impression of Residual Lesion and Appearance on Post-operative Imaging
We will perform fluorescein fluorescence/angiography at surgery and assess if fluorescence reveals any residual tumor or vascular lesion (aneurysm, arteriovenous malformation, or arteriovenous fistula) following surgical intervention. For subjects with brain tumors we will then perform a regular postoperative MRI and assess if there was any residual tumor and measure the accuracy of fluorescein fluorescence to assess the amount of the residual tumor seen on the postoperative MRI. Similarly, for the aneurysms or other vascular lesions, we will perform a regular postoperative angiogram and assess the accuracy of fluorescein angiography results in estimating the amount of residual lesion.
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.

Study Arms (1)

Fluorescein Sodium

EXPERIMENTAL

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 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). 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.

Drug: Fluorescein Sodium

Interventions

Fluorescein SodiumDrug

Also known as: AK-Fluor

Fluorescein Sodium

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Sentara Norfolk General Hospital
Othercollaborator
Indiana University
Otherlead

Study Sites (2)

Aaron Cohen-Gadol, MD

Indianapolis, Indiana, 46202, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

MeSH Terms

Conditions

Brain Neoplasms

Interventions

FluoresceinFluoresceins

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Spiro CompoundsHydrocarbons, CyclicHydrocarbons

Results Point of Contact

Title: Aaron Cohen-Gadol, MD, MSc
Organization: Indiana University

Study Officials

Aaron A Cohen, MD, MSc
IU Health Methodist Hospital
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes
Restrictive Agreement: No

Enrollment

136 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Neurosurgeon

Study Record Dates

First Submitted

December 18, 2013

First Posted

January 7, 2014

Study Start

December 2013

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Results Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Fluorescein Sodium

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Results Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Fluorescein Sodium

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations