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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00961090
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Matthew R Quigley
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Matthew R Quigley, MD
Principal Investigator Affiliation The Guthrie Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Additional Details

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.

Arms & Interventions

Arms

Other: Single-Arm

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

Interventions

Drug: - Aminolevulinic Acid

20 mg/kg mixed in 50cc water and taken orally 3 hours prior to surgery

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Allegheny General Hospital, Pittsburgh, Pennsylvania

Status

Address

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212

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