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

Primary Purpose

Glioblastoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aminolevulinic Acid
Sponsored by
Matthew R Quigley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring Brain tumor, glioma, surgical resection, ALA, ultraviolet light

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Allegheny General Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single-Arm

Arm Description

Single-Arm All subjects received 20mg/kg of Aminolevulinic Acid diluted in 50cc of water, orally, approximately 3 hours prior to surgery.

Outcomes

Primary Outcome Measures

More complete resection of malignant brain tumors

Secondary Outcome Measures

Safety of drug

Full Information

First Posted
August 17, 2009
Last Updated
April 8, 2019
Sponsor
Matthew R Quigley
Collaborators
DUSA Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00961090
Brief Title
Safety Study of Aminolevulinic Acid (ALA) to Improve Visibility of Brain Tumors During Surgery
Official Title
A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Primary Glial Neoplasms of the Brain.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
April 22, 2015 (Actual)
Study Completion Date
April 23, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Matthew R Quigley
Collaborators
DUSA Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
Brain tumor, glioma, surgical resection, ALA, ultraviolet light

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single-Arm
Arm Type
Other
Arm Description
Single-Arm All subjects received 20mg/kg of Aminolevulinic Acid diluted in 50cc of water, orally, approximately 3 hours prior to surgery.
Intervention Type
Drug
Intervention Name(s)
Aminolevulinic Acid
Other Intervention Name(s)
ALA
Intervention Description
20 mg/kg mixed in 50cc water and taken orally 3 hours prior to surgery
Primary Outcome Measure Information:
Title
More complete resection of malignant brain tumors
Time Frame
3-7 days
Secondary Outcome Measure Information:
Title
Safety of drug
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew R Quigley, MD
Organizational Affiliation
The Guthrie Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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