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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

Must not have

History of liver disease within the last 12 months

Elevated LFTs (AST, ALT, ALP or bilirubin levels greater than 2.5 times the normal limit) from laboratory tests conducted within 30 days prior to surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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 below

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I am diagnosed with a type of brain tumor (glioma) for the first time.

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I am 21 years old or older.

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My tumor can be surgically removed from my brain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had liver disease in the past year.

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My liver function tests are more than 2.5 times the normal limit.

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My kidney function test shows creatinine over 2.04 mg/dL recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fluorescein performance as an intraoperative biomarker for tumor tissue will be reported.

Secondary study objectives

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

Awards & Highlights

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.

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

0 / 6Eligibility criteria met