ALA-induced PpIX Fluorescence for Brain Tumor
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to help surgeons see brain tumors more clearly during surgery. The treatment uses 5-aminolevulinic acid (ALA), a special substance that makes the tumor glow under certain light, aiding surgeons in more complete removal. The goal is to leave no tumor material behind, potentially preventing regrowth. This trial may suit individuals diagnosed with certain brain tumors, such as gliomas or meningiomas, who are planning surgery. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that 5-aminolevulinic acid is likely to be safe for humans?
Research shows that 5-aminolevulinic acid (5-ALA) is generally safe for use in brain tumor surgeries. Studies have found that patients tolerate 5-ALA well, with no major side effects reported. In surgeries for high-grade gliomas, patients did not encounter significant safety issues when 5-ALA was used. This treatment helps surgeons see the tumor more clearly during surgery, which is crucial for removing as much of it as possible. Although this trial remains in its early stages, existing safety data from other studies is encouraging.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about 5-aminolevulinic acid for brain tumors because it offers a unique approach to surgery. Unlike standard treatments that primarily rely on imaging and physical examination, this method uses an active ingredient, 5-aminolevulinic acid, which induces PpIX fluorescence. This fluorescence helps surgeons see tumor cells more clearly during surgery, potentially leading to more precise tumor removal. By enhancing visibility, it may improve surgical outcomes and reduce the likelihood of leaving behind cancerous tissue.
What evidence suggests that 5-aminolevulinic acid might be an effective treatment for brain tumors?
Research has shown that 5-aminolevulinic acid (5-ALA), which participants in this trial will receive, helps surgeons see brain tumors more clearly during surgery. Studies have found that using 5-ALA improves the removal of high-grade gliomas, a type of brain tumor. Patients whose surgeries used 5-ALA lived longer overall and experienced longer periods without tumor regrowth. In one study, patients using 5-ALA had a median survival of 502 days, compared to 370 days for those who didn't use it. Additionally, 5-ALA is well-tolerated, meaning it doesn't cause significant side effects. This evidence supports its effectiveness in helping surgeons remove brain tumors more completely.16789
Who Is on the Research Team?
David W. Roberts, MD
Principal Investigator
Dartmouth-Hitchcock Medical Center
Are You a Good Fit for This Trial?
This trial is for adults over 21 with a brain tumor diagnosis suitable for surgery, without serious psychiatric illnesses. It's not for pregnant or breastfeeding women, those with photosensitivity issues, recent liver disease, dermatitis, or high creatinine levels.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 5-aminolevulinic acid (20mg/kg) 3 hours prior to surgery for brain tumor resection
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 5-aminolevulinic acid
Find a Clinic Near You
Who Is Running the Clinical Trial?
David W. Roberts
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator