A Phase 2 interventional study of Fluorescein and Fluorescein + ALA in Brain Cancer, sponsored by David W. Roberts. Active, not recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by David W. Roberts · Phase 2, Interventional, and Diagnostic
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.
Consenting subjects who have met inclusion and exclusion criteria will be enrolled to receive either fluorescein+ALA or fluorescein alone. HGG patients will be randomized on a 2 to 1 basis to receive either both fluorescein and ALA or fluorescein alone, and LGG patients will be randomized on a 1 to 1 basis.
This study is a diagnostic trial of fluorescein fluorescence as an intraoperative imaging biomarker during open cranial surgery for tumor resection of first-time (preoperatively) presumed high or low grade glioma. Subjects participate in a "one-time" event/visit (i.e, surgery) as part of this protocol. Images and data from the patient's pre- and post-operative MR scans are used for analysis in the study, but these acquisitions are part of the patient's standard-of-care, would occur independently of whether the participant is enrolled; and thus, are not considered to be research study visits. No post-surgical follow-up visit is part of the protocol data collection or analysis. Patients are monitored for possible adverse events through the routine follow-up under the care of the operating surgeon involved in the study procedures, post-operatively and subsequently through the medical record. Hence, this information is already being collected as part of standard-of-care and is available for adverse event surveillance. Patients receiving ALA who present with abnormally elevated LFTs beyond the peri-operative observation period are monitored on a regular basis until resolution and this blood testing is considered to be part of the study.
Administration of study drug:
Patients enrolled in the fluorescein+ALA arm will be administered orally 5-ALA (DUSA Pharmaceuticals, Tarrytown, NY) at 20 mg/kg body weight, dissolved in 100 ml of water, approximately 3 hours prior to the induction of anesthesia.
For patients receiving only fluorescein, the operating surgeon will request bolus injection (at a dose of 5 mg/kg) approximately 30 minutes prior to the start of tumor resection. For especially long cases (e.g., > 4 h) or if fluorescein fluorescence dissipates substantially during the course of the procedure, a second bolus injection may occur later in the case.
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →David W. Roberts is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Fluorescein
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.
Drug: Fluorescein + ALA
Also known as: Fluorescite
Also known as: Flourescein = Fluorescite; ALA = 5-Aminolevulinic Acid
Fluorescein performance as an intraoperative biomarker for tumor tissue will be reported.
The predictive performance of fluorescein fluorescence as an intraoperative imaging biomarker of tumor during surgery in patients with a clinical diagnosis of high grade glioma (HGG) and patients with a clinical diagnosis of low grade glioma (LGG) will be measured. Fluorescence will be measured both quantitatively via an intraoperative probe and visually by the neurosurgeon through the operating microscope. Endpoints will be assessed separately for HGG and LGG groups.
Time frame: 24 months
Fluorescein performance as visualized and measured with an intraoperative probe will be reported
The performance of fluorescein as visualized by the neurosurgeon and measured quantitatively with an intraoperative probe will be analyzed to the contrast-enhancement on coregistered preoperative MR scans in patients with a clinical diagnosis of high grade glioma.
Time frame: 24 months
Fluorescein versus fluorescein + ALA performance will be reported in patients in patients with 2 different types of tumors
The performance of fluorescein versus fluorescein + ALA as visualized by the neurosurgeon and measured quantitatively with an intra-operative probe will be analyzed in patients with a clinical diagnosis of either high grade glioma (HGG) or low grade glioma (LGG).
Time frame: 24 months
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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David W. Roberts