Fluorescence-guided Surgery for Low- and High-grade Gliomas

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Gliomas are the most common primary brain tumor, yet remain a challenge to effectively treat. Mounting evidence suggests that survival improves with greater tumor removal, yet being able do a complete removal can be difficult due to the tumor's infiltrating nature. 5-aminolevulinic acid (5-ALA) is a natural compound that, when patients take it by mouth 3 hours before surgery, is selectively taken up by glioma cells and causes a red/pink fluorescence (glow) under a blue light that allows tumor margins to be seen during the course of surgery. While this compound is used as a standard-of-care agent in Europe, it remains under testing by the Food and Drug Administration (FDA). A recent clinical trial in Germany, however, has demonstrated a significant improvement in the rate of complete resection for certain brain tumors (65% vs. 34%).

The Barrow 5-ALA Intraoperative Confocal (BALANCE) Trial will measure the effect of 5-ALA on the amount of glioma tumor removal. To improve the usefulness of 5-ALA, a new special microscope fitted with a blue light, will be used to magnify microscopic fluorescence at the tumor margins. The investigators' hypothesis is that 5-ALA fluorescence with the use of the special microscope during surgery will greatly lower the amount of tumor left behind.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
• Treatments: Aminolevulinic Acid; Ascorbic Acid

Criteria

Inclusion Criteria:

• Presumed newly-diagnosed supratentorial glioma (previous biopsy-only/no adjuvant therapy are eligible for randomization)

• Age > 18 years

• Normal bone marrow function (WBC > 3000, Platelets > 100,000)

Exclusion Criteria:

• Infratentorial tumors

• Pregnancy

• Hypersensitivity to 5-aminolevulinic acid hydrochloride or porphyrins

• History of photosensitivity, porphyria, or exfoliative dermatitis

• Hepatic dysfunction in the last 12 months (defined by AST, ALT, ALP, bilirubin > 2.5 x normal)

• Serum creatinine > 180 µmol/L

• Estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73m2

• Inability to undergo MRI scan with contrast