Actively Recruiting
Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker
Led by David W. Roberts · Updated on 2025-08-03
30
Participants Needed
1
Research Sites
561 weeks
Total Duration
On this page
Sponsors
D
David W. Roberts
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preoperative diagnosis of presumed first-time low or high grade glioma (astrocytoma, oligodendroglioma, mixed oligo-astrocytoma, anaplastic astrocytoma, glioblastoma multiforme)
- Tumor suitable for open cranial resection based on preoperative imaging
- Valid informed consent given by participant or legal representative
- No serious psychiatric illnesses
- Age 21 years or older
You will not qualify if you...
- Pregnant or breastfeeding women
- History of allergy or hypersensitivity to fluorescein
- History of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, or exfoliative dermatitis
- History of liver disease within the past 12 months
- Elevated liver function tests (AST, ALT, ALP, or bilirubin greater than 2.5 times normal) within 30 days before surgery
- Serum creatinine above 180 µmol/L (2.04 mg/dL) within 30 days before surgery
- Unable to follow photosensitivity precautions required by the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sally B Mansur
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
Research Team
S
Sally B Mansur, MS
CONTACT
K
Keith D Paulsen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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