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Fluorescein for Brain Tumor Diagnosis
Phase 2
Recruiting
Led By David W Roberts, MD
Research Sponsored by David W. Roberts
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Preoperative diagnosis of either presumed first-time low or high grade glioma (astrocytoma, oligodendroglioma, mixed oligo-astrocytoma, anaplastic astrocytoma, and glioblastoma multiforme)
Age ≥ 21 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial will study whether using fluorescein can help doctors better understand brain tumors.
Who is the study for?
This trial is for adults over 21 with a first-time diagnosis of operable brain tumors, specifically high-grade or low-grade gliomas. Candidates must be able to give informed consent and not have serious psychiatric illnesses. Pregnant women, individuals with recent liver disease, abnormal liver function tests, high serum creatinine levels, or those sensitive to light due to medication cannot participate.Check my eligibility
What is being tested?
The study is testing the effectiveness of fluorescein as a marker during brain surgery when viewed through special microscopes. It's compared against MRI scans before surgery, another dye called ALA that also lights up under microscope light, and actual tissue samples from the tumor.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to fluorescein if there's a history of hypersensitivity. Also, patients need to follow precautions related to photosensitivity because both dyes used can make skin more sensitive to light.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am diagnosed with a type of brain tumor (glioma) for the first time.
Select...
I am 21 years old or older.
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My tumor can be surgically removed from my brain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fluorescein performance as an intraoperative biomarker for tumor tissue will be reported.
Secondary outcome measures
Fluorescein performance as visualized and measured with an intraoperative probe will be reported
Fluorescein versus fluorescein + ALA performance will be reported in patients in patients with 2 different types of tumors
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Fluorescein + ALAExperimental Treatment1 Intervention
Fluorescein administered IV at 5mg/kg approximately 30 minutes prior to the beginning of the tumor resection. A second injection may occur if the fluorescein fluorescence is dissipated substantially during the course of the procedure.
ALA administered orally at 20mg/kg approximately 3 hours before surgery.
Group II: FluoresceinActive Control1 Intervention
Fluorescein administered IV at 5mg/kg approximately 30 minutes prior to the beginning of the tumor resection. A second injection may occur if the fluorescein fluorescence is dissipated substantially during the course of the procedure.
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Who is running the clinical trial?
David W. RobertsLead Sponsor
2 Previous Clinical Trials
645 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,342 Previous Clinical Trials
650,322 Total Patients Enrolled
Carl Zeiss Meditec, Inc.Industry Sponsor
22 Previous Clinical Trials
5,620 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am diagnosed with a type of brain tumor (glioma) for the first time.I have had liver disease in the past year.I am 21 years old or older.My tumor can be surgically removed from my brain.You have had a bad reaction to fluorescein in the past.You have a history of skin conditions that make you sensitive to sunlight.My liver function tests are more than 2.5 times the normal limit.My kidney function test shows creatinine over 2.04 mg/dL recently.
Research Study Groups:
This trial has the following groups:- Group 1: Fluorescein + ALA
- Group 2: Fluorescein
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are allowed to participate in this experiment at one time?
"Yes. The online clinicaltrial database shows that the trial is looking for 30 participants and was last updated on 8/2/2022."
Answered by AI
Are participants still being gathered for this experiment?
"The study, as detailed on clinicaltrials.gov, is looking for willing participants. The 3/1/2016 date marks when the trial was first posted while 8/2/2022 is the date of the most recent edit."
Answered by AI
Are there other precedents for using Fluorescein + ALA?
"Right now, there are 26 ongoing studies involving Fluorescein + ALA with 3 trials in Phase 3. Most of the clinical trials for Fluorescein + ALA are taking place in Lebanon and New hampshire, but there are a total of 280 research locations worldwide."
Answered by AI
Is there a heightened risk associated with Fluorescein + ALA?
"While there is some evidence that Fluorescein + ALA is safe, as this is a Phase 2 trial, no data currently supports its efficacy."
Answered by AI
What skin conditions can be helped with the use of Fluorescein + ALA?
"Fluorescein + ALA is most often used to treat pneumocystis, though it can also be taken as a form of treatment for actinic cheilitis, pneumonia caused by pneumocystis jirovecii, and certain types of skin cancer."
Answered by AI
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