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Photosensitizer

ALA-induced PpIX Fluorescence for Brain Tumor

Phase 1
Waitlist Available
Led By David W. Roberts, MD
Research Sponsored by David W. Roberts
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Tumor judged to be suitable for open cranial resection based on preoperative imaging studies
Preoperative diagnosis of either presumed first-time low or high grade glioma, or recurrent glioma, or metastasis, or meningioma
Must not have
Plasma creatinine in excess of 180umol/L within 30 days prior to surgery
History of liver disease within the last 12 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to five years from the first surgery date
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to help surgeons remove brain tumors by using a dye that makes the tumor boundaries easier to see.

Who is the study for?
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.
What is being tested?
The study tests the use of a substance called 5-aminolevulinic acid (ALA) to make tumor cells glow during surgery. This could help surgeons see and remove the entire tumor more effectively.
What are the potential side effects?
Potential side effects may include skin sensitivity to light due to ALA. Patients must take precautions against exposure to bright lights before and after receiving this treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My tumor can be surgically removed through an open skull surgery.
Select...
I have been diagnosed with a type of brain tumor for the first time or have a recurring brain tumor.
Select...
I am over 21 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My kidney function test showed creatinine over 180umol/L recently.
Select...
I have had liver disease in the past year.
Select...
My liver tests show levels more than 2.5 times the normal limit.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to five years from the first surgery date
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to five years from the first surgery date for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Comparison of intraoperative measurements of PpIX concentration to coregistered histopathology

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental: 5-aminolevulinic acidExperimental Treatment1 Intervention
20mg/kg 3 hours prior to surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
5-aminolevulinic acid
2019
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

David W. RobertsLead Sponsor
2 Previous Clinical Trials
135 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,381 Previous Clinical Trials
651,710 Total Patients Enrolled
David W. Roberts, MDPrincipal InvestigatorDartmouth-Hitchcock Medical Center

Media Library

5-aminolevulinic acid (Photosensitizer) Clinical Trial Eligibility Overview. Trial Name: NCT02191488 — Phase 1
Brain Tumor Research Study Groups: Experimental: 5-aminolevulinic acid
Brain Tumor Clinical Trial 2023: 5-aminolevulinic acid Highlights & Side Effects. Trial Name: NCT02191488 — Phase 1
5-aminolevulinic acid (Photosensitizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02191488 — Phase 1
~29 spots leftby Jul 2025
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