ALA-induced PpIX Fluorescence for Brain Tumor

Recruiting in Palo Alto (17 mi)

Overseen byDavid W. Roberts, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: David W. Roberts

No Placebo Group

Trial Summary

What is the purpose of this trial?Removing a tumor from a patients brain is hard to do because, very often, brain tumors do not have boundaries that are easy for the patients surgeon to find. In many cases, the surgeon can't tell exactly where the tumor begins or ends. The surgeon usually can remove most of the patient's tumor by looking at the MRI images that were taken of the patient's brain before surgery. However, the surgeon does not have any good way to tell if the entire tumor has been removed or not. Removing the entire tumor is very important because leaving tumor behind may allow it to grow back which could decrease the chances of survival.

Eligibility Criteria

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

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

Patient or LAR able to provide written informed consent

No serious associated psychiatric illnesses

+2 more

Exclusion Criteria

Pregnant women or women who are breast feeding

Inability to comply with the photosensitivity precautions associated with the study

My kidney function test showed creatinine over 180umol/L recently.

+3 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Experimental: 5-aminolevulinic acidExperimental Treatment1 Intervention

20mg/kg 3 hours prior to surgery