Fluorescein for Brain Tumor Diagnosis
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byDavid W Roberts, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: David W. Roberts
Disqualifiers: Pregnancy, Liver disease, Photosensitivity, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a history of liver disease or elevated liver function tests, this may affect your eligibility.
What data supports the effectiveness of the drug Fluorescein for brain tumor diagnosis?
Research shows that sodium fluorescein is effective in brain tumor surgeries because it accumulates in tumor tissues, making them more visible and easier to distinguish from normal brain tissue. This helps surgeons remove tumors more accurately.
12345Is fluorescein safe for use in brain tumor diagnosis?
Fluorescein sodium is considered highly safe and has been widely used in brain tumor surgeries to help distinguish tumor tissue from normal brain tissue. It is inexpensive, easy to use, and does not require special equipment, although its definitive role in pediatric cases is still being studied.
13678How does the drug fluorescein differ from other treatments for brain tumors?
Fluorescein is unique because it is a fluorescent dye that accumulates in brain tumors with a damaged blood-brain barrier, allowing surgeons to see the tumor more clearly during surgery. This helps in distinguishing tumor tissue from normal brain tissue, potentially leading to more complete tumor removal.
12389Eligibility Criteria
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.Inclusion Criteria
I am diagnosed with a type of brain tumor (glioma) for the first time.
Valid informed consent by subject or subject's LAR
I am 21 years old or older.
+2 more
Exclusion Criteria
Pregnant women or women who are breast feeding
Inability to comply with the photosensitivity precautions associated with the study
I have had liver disease in the past year.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Surgery
Participants undergo open cranial surgery for tumor resection with administration of fluorescein and/or ALA
1 day
1 visit (in-person)
Follow-up
Participants are monitored for adverse events through routine follow-up under the care of the operating surgeon
24 months
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Dartmouth Hitchcock Medical CenterLebanon, NH
Sally B MansurLebanon, NH
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Who Is Running the Clinical Trial?
David W. RobertsLead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)Collaborator
Carl Zeiss Meditec, Inc.Industry Sponsor
References
Safeness of sodium fluorescein administration in neurosurgery: Case-report of an erroneous very high-dose administration and review of the literature. [2023]Sodium Fluorescein has become a validated and widely used fluorescent dye in neuro-oncological surgery, thanks to its ability to accumulate in cerebral with a damaged blood-brain barrier. It concentrates at the tumor site, enhancing the lesion, and helps in the discrimination between tumor and normal brain parenchyma.
The use of the YELLOW 560 nm surgical microscope filter for sodium fluorescein-guided resection of brain tumors: Our preliminary results in a series of 28 patients. [2022]Sodium fluorescein (Na-Fl) is a fluorescent dye that accumulates in tumoral tissues via disrupted blood-brain barrier. It has been used in fluorescence-guided surgery for various brain tumors. Herein, we report our initial experience and preliminary results for the first 28 patients who were operated on under Na-Fl guidance with the use of a special filter on the surgical microscope.
Intraoperative fluorescein staining for benign brain tumors. [2017]Successful use of high-dose fluorescein-sodium (20mg/kg) with a standard light microscope for resection of high-grade gliomas, meningiomas, hemangioblastoma and metastases was reported. The principle of brain tumor staining by fluorescein-sodium (Fl-Na) consists in the accumulation of fluorescein in brain tumors with impaired blood-brain barrier. The aim of our study was to investigate for the first time the usefulness of high-dose fluorescein in patients operated on for benign neuroepithelial brain tumors (grade I WHO tumors) with contrast enhancement on magnetic resonance imaging.
The utilization of fluorescein in brain tumor surgery: a systematic review. [2019]Sodium fluorescein (SF) is a green, water-soluble dye with the capacity to accumulate in cerebral areas as a result of damaged blood-brain barrier (BBB); this property allows SF to concentrate specifically at the tumor site of various types of brain neoplasms, making the tumor tissue more clearly visible.
[Microsurgical resection of glioblastoma guided with intraoperative fluorescein: a Retrospective evaluation]. [2018]To evaluate the influence of the use of sodium fluorescein (FLS-Na) in surgery of glioblastoma (GB) on the degree of tumor resection and survival in patients treated at the National Institute of Neoplastic Diseases.
Focus session on sodium fluorescein in pediatric oncological neurosurgery. [2023]Many tools and techniques have been developed to obtain maximal safe tumoral resection in neurosurgery. Fluorescent dyes, including sodium fluorescein, have become also part of this armamentarium to localize the lesion and its boundaries peroperatively. Considering its alleged safety profile and its ability to diffuse in areas of altered blood-brain barrier, a typical characteristic of a number of both benign and malignant pediatric tumors, sodium fluorescein may appear an ideal candidate as intraoperative adjunct in pediatric neurosurgery. Nevertheless, a definitive role of this dye in children has not been established yet, and the reports on the pediatric population remain scarce. For this reason, we propose focusing on the use of sodium fluorescein in pediatric oncological neurosurgery by collecting articles reporting the result of the application of the technique in the management of intracranial pediatric tumors.
Metastatic brain tumor surgery using fluorescein sodium: technical note. [2015]As for the surgical treatment of glioma, the recent employment of fluorescence-guided resection using 5-aminolevulinic acid (5-ALA) or high-dose fluorescein sodium has increased the rate of radical tumor resection. On the other hand, there is no specific technique for metastatic brain tumor surgery. We have used a fluorescence-guided tumor resection procedure with the aid of high-dose fluorescein sodium in surgery for metastatic brain tumor. Fluorescein sodium has been used in 13 cases, and achieved effective stainability in all cases. Fluorescein sodium is inexpensive, highly safe, and comparatively easy to use, and does not require any special equipment. We believe that the use of fluorescein sodium is beneficial for resection of the metastatic brain tumor.
Fluorescein-guided resection of cerebral metastases is associated with greater tumor resection. [2022]Sodium fluorescein (fluorescein) crosses a disrupted blood-brain barrier similarly to gadolinium contrast in contrast-enhancing cerebral tumors. When exposed to light with 560 nm wavelength during surgery, fluorescein emits a yellow-green fluorescent light that can be visualized through an operating microscope equipped with an appropriate emission filter. The distribution of the fluorescence correlates with the contrast on a gadolinium contrast-enhanced MRI.
Fluorescein-Guided Surgery for Malignant Gliomas. [2023]Fluorescein (FS) was first used to visualize malignant brain tumors in 1948. FS accumulates in malignant gliomas where the blood-brain barrier is disrupted and provides intraoperative visualization that is similar to preoperative contrast-enhanced T1 images in which gadolinium accumulation is seen.1 FS can be viewed under white light, but the use of an operating microscope fitted with a dedicated filter (YELLOW 560 nm Filter, Carl Zeiss Meditec, Oberkochen, Germany) allows us to significantly reduce the dose needed to highlight tumoral tissue.1,2 FS is excited at 460-500 nm and emits a green, fluorescent emission wavelength at 540-690 nm.2 It is virtually free of side effects and has low costs3 (approximately 6.9 USD each vial: Brazil). Video 1 presents a case of a 63-year-old man who underwent a left temporal craniotomy to remove a temporal polar tumor. The FS is administered at the time of anesthesia before a craniotomy. The tumor was then removed with standard microneurosurgical technique by the alternating use of white light and YELLOW 560 nm filter illumination. The use of FS was found "helpful" to discriminate the brain tissue and tumor tissue (bright yellow). Fluorescein-guided technique with a dedicated filter on the surgical microscope is safe and allows complete resection of high-grade gliomas.