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NCT00961090 Clinical Trial

Safety Study of Aminolevulinic Acid (ALA) to Improve Visibility of Brain Tumors During Surgery

Glioblastoma Clinical Trial

Official title:
A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Primary Glial Neoplasms of the Brain.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00961090
Other study ID # 104974
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2009
Est. completion date April 23, 2015

Study information
Verified date September 2015
Source Allegheny Singer Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A one time oral dose of ALA is taken before surgery. The medication makes the tumor visible under ultraviolet light which allow the surgeon to see more of the tumor for a more complete removal.

Description:

Patients with primary neoplastic brain tumors (Grades II-IV) will participate in this trial. Each patient will have been evaluated and found to have such a tumor by history and recent imaging studies (MRI) and deemed a surgical candidate based on current neurosurgical standards of care.

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date April 23, 2015
Est. primary completion date April 22, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Suspected primary brain tumor

- 18 years of age or more

- Normal marrow and organ function

- Eastern Cooperative Group performance status = 2

- Women of childbearing potential must use adequate birth control

- Ability to understand and willingness to sign a written informed consent form

- Life expectancy not a consideration

Exclusion Criteria:

- Receiving any other investigational agents

- History of allergic reactions to ALA

- Personal or family history of porphyrias

- Liver disease in the past year

- Uncontrolled intercurrent illness

- Pregnant or lactating women

- Inability to undergo MRI with contrast

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Aminolevulinic Acid
20 mg/kg mixed in 50cc water and taken orally 3 hours prior to surgery

Locations
Country Name City State
United States Allegheny General Hospital Pittsburgh Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Matthew R Quigley DUSA Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary More complete resection of malignant brain tumors 3-7 days
Secondary Safety of drug 1 month
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