Study on the Use of 5-ALA for Better Visualization During Surgery in Children with Brain Tumors

Sponsor: Costas Hadjipanayis

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06907485

Provider View

This study is exploring the use of a special drug, 5-ALA, to help surgeons see brain tumors more clearly during surgery in children aged 2 to 18. The drug is already used in adults and this trial aims to see if it can be safely used in children to improve tumor removal.

Patient Parameters

Program Overview

This clinical trial is for children aged 2 to 18 who have a new or returning brain tumor and are scheduled for surgery. The study is testing a drug called 5-aminolevulinic acid (5-ALA), which helps make brain tumors glow during surgery, making it easier for doctors to remove them. The drug is already approved for use in adults. In this study, children will take 5-ALA by mouth 6 to 12 hours before their surgery. They will receive standard care for their surgery and will be closely monitored before, during, and after the procedure to ensure safety. Since 5-ALA can make skin sensitive to light, children will stay in dim lighting for 48 hours after surgery to prevent sunburn-like reactions. The study will follow participants from the time they join until six months after their surgery.

Description

The goal of this study is to see if 5-ALA can be used safely in children to help surgeons see and remove brain tumors more effectively. In this study, children with certain types of brain tumors will take 5-ALA before their surgery. This drug makes the tumor glow under special lights, helping doctors remove it more completely.

The study involves 20 children who will take 5-ALA by mouth before their surgery. During the operation, doctors will use special lights to see the glowing tumor and decide how much to remove. They will also take samples of the tumor to study it further.

After surgery, children will stay in dim lighting for 48 hours to avoid skin reactions from light sensitivity caused by 5-ALA. They will have regular check-ups, including physical exams and MRIs, before surgery and at several points after surgery, up to six months later, to monitor their recovery and the effects of the treatment.

The study will also collect information on how well the drug works in making the tumor glow and how safe it is for children. This information will help determine if 5-ALA can be used regularly in pediatric brain tumor surgeries.

Eligibility Criteria

Inclusion Criteria

  • Children aged 2 to 17 years and 182 days with a new or returning brain tumor that needs surgery.
  • Tumor types include pilocytic astrocytoma, pleomorphic xanthoastrocytoma, ganglioglioma, and others.
  • Must have normal organ and bone marrow function, as shown by specific blood tests.
  • Girls who can have children must take a pregnancy test before surgery.
  • Ability to understand and agree to participate in the study, with consent from a guardian and assent from the child when appropriate.
  • Open to all genders and ethnic groups.

Exclusion Criteria

  • Unable to swallow the 5-ALA solution.
  • Tumors located in the brain stem.
  • Allergic reactions to similar drugs or use of certain other medications.
  • Personal or family history of porphyria.
  • Uncontrolled illnesses or conditions that could interfere with the study.
  • Pregnant girls or those who become pregnant during the study.
  • History of gastrointestinal issues like perforation or ulcers.

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