RecruitingPhase 2NCT02691923

Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker

Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker: Correlation With Preoperative MR, ALA-induced PpIX Fluorescence, and Histopathology


Sponsor

David W. Roberts

Enrollment

30 participants

Start Date

Mar 1, 2016

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical research will evaluate the diagnostic potential of fluorescein as visualized through an operating microscope relative to 1) contrast enhancement on co-registered preoperative MR scans, 2) intraoperative ALA-induced PpIX fluorescence and 3) gold-standard histology obtained from biopsy sampling during the procedure. Subjects will include those people with operable brain tumor with first-time presumed pre-surgical diagnosis of high-grade glioma or low-grade glioma.


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether fluorescein — a harmless dye that causes abnormal brain tumor tissue to glow bright yellow-green under specific surgical lights — can help surgeons better see and remove brain tumors (gliomas) more completely during surgery. **You may be eligible if...** - You have been diagnosed with a brain tumor (glioma) that requires surgical removal - You are scheduled for brain surgery at a participating center - You are an adult in adequate overall health - You are willing to undergo the fluorescein dye injection as part of your procedure **You may NOT be eligible if...** - You have a known allergy to fluorescein or similar dyes - You have severe kidney or liver disease - Your tumor is a type that would not benefit from this technique - You are pregnant - You are not scheduled for surgical removal of the tumor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFluorescein
DRUGFluorescein + ALA

Locations(1)

Sally B Mansur

Lebanon, New Hampshire, United States

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NCT02691923


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