Using fluorescein to improve brain tumor surgery outcomes

Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker: Correlation With Preoperative MR, ALA-induced PpIX Fluorescence, and Histopathology

This study is testing if using a special dye called fluorescein during brain tumor surgery can help doctors see the tumors better and improve outcomes for patients with gliomas.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Dartmouth-Hitchcock Medical Center (Academic / other)
• Locations: 1 site (Lebanon, New Hampshire)
• Trial ID: NCT02691923 on ClinicalTrials.gov

What this trial studies

This clinical research evaluates the effectiveness of fluorescein as a diagnostic tool during brain tumor surgeries, specifically for high-grade and low-grade gliomas. Participants will receive either fluorescein alone or in combination with another agent called ALA, with the goal of enhancing tumor visualization during surgery. The study compares fluorescein's performance against preoperative MR scans and other established diagnostic methods. Patients will be monitored for any adverse events as part of standard care during their surgical procedure.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 and older with a first-time diagnosis of operable low or high-grade glioma.

Not a fit: Patients with serious liver disease, hypersensitivity to fluorescein, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate tumor resections and improved surgical outcomes for patients with brain cancer.

How similar studies have performed: Other studies have shown promising results using similar intraoperative imaging techniques, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Preoperative diagnosis of either presumed first-time low or high grade glioma (astrocytoma, oligodendroglioma, mixed oligo-astrocytoma, anaplastic astrocytoma, and glioblastoma multiforme).
2. Tumor judged to be suitable for open cranial resection based on preoperative imaging studies.
3. Valid informed consent by subject or subject's LAR.
4. No serious associated psychiatric illnesses.
5. Age ≥ 21 years old.

Exclusion Criteria:

1. Pregnant women or women who are breast feeding.
2. History of hypersensitivity to fluorescein.
3. History of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis.
4. History of liver disease within the last 12 months.
5. 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.
6. Serum creatinine in excess of 180µmol/L (2.04 md/dL) within 30 days prior to surgery.
7. Inability to comply with the photosensitivity precautions associated with the study.

Where this trial is running

Lebanon, New Hampshire

• Sally B Mansur — Lebanon, New Hampshire, United States (Recruiting)

Study contacts

• Principal investigator: David W Roberts, MD — Dartmouth-Hitchcock Medical Center
• Study coordinator: Sally B Mansur, MS

Conditions Brain Cancer; High Grade Glioma; Low Grade Glioma; Brain Tumor