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Safety Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Tumors of the Brain

NCT01116661 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2019-05-29

Study results available
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Summary

The prodrug, 5-Aminolevulinic acid (ALA), has been shown to lead to intracellular accumulation of fluorescent porphyrins in high grade malignant gliomas in the brain. On imaging, this accumulation of fluorescent porphyrins helps delineate tumor borders, resulting in the surgeon being better able to visualize and thus able to make a complete, or near-complete resection of the tumor.

Conditions

Interventions

DRUG

5-Aminolevuline Acid (ALA)

Given orally at a dose of 20 mg/kg body weight 3hrs before anesthesia prior to surgery

Sponsors & Collaborators

Principal Investigators

  • Mitchel S Berger, MD · UCSF Department of Neurosurgery

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2017-12-28
Completion
2019-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01116661 on ClinicalTrials.gov