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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to five years from the first surgery date

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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My tumor can be surgically removed through an open skull surgery.

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I have been diagnosed with a type of brain tumor for the first time or have a recurring brain tumor.

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I am over 21 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to five years from the first surgery date

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Comparison of intraoperative measurements of PpIX concentration to coregistered histopathology

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

0 / 3Eligibility criteria met

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

1,339 Previous Clinical Trials

648,850 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the common purpose for ingesting 5-aminolevulinic acid?

"5-aminolevulinic acid can be used as a therapeutic intervention for scalp structure and the two most common types of carcinoma: squamous cell and non-squamous."

Answered by AI

Has 5-aminolevulinic acid been validated by the Food and Drug Administration?

"Our department has concluded that 5-aminolevulinic acid is likely safe, judging by the Phase 1 trial data available. This score of 1 reflects our limited understanding of its efficacy and safety profile."

Answered by AI

Is enrolment for this experiment still taking place?

"The recruitment phase of this trial has come to an end and it hasn't been updated since May 3rd 2022. For individuals seeking other opportunities, there are 408 clinical trials enrolling patients with neoplasms or brain issues, as well 18 for 5-aminolevulinic acid."

Answered by AI

Could you provide details of prior experiments involving 5-aminolevulinic acid?

"Currently, 18 clinical trials for 5-aminolevulinic acid are ongoing; 2 of them have reached Phase 3. Lebanon, New hampshire serves as the central hub for these studies but there are 56 sites running experiments on this drug across the United States."

Answered by AI

How many participants have been enrolled in this medical trial so far?

"This clinical trial is not recruiting. The postings for this study, which was initially posted on July 1st 2014 and last updated on May 3rd 2022, indicate that the study has been completed. Fortunately, other studies are available with 408 trials actively enrolling patients suffering from neoplasms or brain related issues as well as 18 different 5-aminolevulinic acid based trials looking for subjects."

Answered by AI

Recent research and studies

Journal of NeurosurgeryJournal

Red-light Excitation of Protoporphyrin IX Fluorescence for Subsurface Tumor Detection

Roberts, David W., Jonathan D. Olson, Linton T. Evans, Kolbein K. Kolste, Stephen C. Kanick, Xiaoyao Fan, Jaime J. Bravo, et al.. 2018. “Red-light Excitation of Protoporphyrin IX Fluorescence for Subsurface Tumor Detection”. Journal of Neurosurgery. Journal of Neurosurgery Publishing Group (JNSPG). doi:10.3171/2017.1.jns162061.

clinicaltrials.govStudy

ALA-induced PpIX Fluorescence During Brain Tumor Resection

David W. Roberts 2014. "ALA-induced PpIX Fluorescence During Brain Tumor Resection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02191488.

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