MedTrace Logo

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

NCT01502280 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2023-11-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

5-Aminolevulinic acid (ALA)

Following informed consent, within 3 hours prior to surgery, patient will orally ingest \[or be given via Nasogastric (NG), Orogastric (OG), or Gastric tube (G-tube)\] either (1) 5-ALA/Gliolan® mixed with sterile water (20mg/kg)

DRUG

Placebo - ascorbic acid

Within 3 hours prior to surgery, patient will orally ingest \[or be given via Nasogastric (NG), Orogastric (OG), or Gastric tube (G-tube)\] 1.5 Gm. placebo - ascorbic acid in 50 ml sterile water.

Sponsors & Collaborators

  • St. Joseph's Hospital and Medical Center, Phoenix

    lead OTHER

Principal Investigators

  • Nader Sanai, MD · St. Joseph's Hospital Medical Center, Phoenix

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2018-01-31
Completion
2018-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01502280 on ClinicalTrials.gov