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Fluorescence Guided Resection of Brain Tumors

NCT00870779 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2019-06-14

No results posted yet for this study

Summary

Removing a tumor from your brain is hard to do because, very often, brain tumors do not have boundaries that are easy for your 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 your tumor by looking at the MRI images that were taken of your 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 your chances of survival.

It is possible to detect tumor cells by making them glow with a specific color of light (a process called fluorescence). This can be done by having you take the drug, ALA, before your surgery. ALA is a molecule that already exists in the cells of your body. Once enough of it is in your body, it gets converted into another molecule named PpIX. If blue light is shined on a tumor that has enough PpIX, it will glow with red light (fluorescence) that can be detected with a special camera. In this study, we want to determine how the fluorescence (red light) is related to the tumor which appears in the images that are normally taken of your brain (which the surgeon uses to guide the removal of your tumor) and the tumor tissue that will be removed during your surgery. Removing the entire tumor is very important because leaving tumor behind may allow it to grow back which could decrease your chances of survival.

Conditions

Interventions

DRUG

5-aminolevulinic acid

20mg/kg 3 hours prior to surgery

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • David W. Roberts

    lead OTHER

Principal Investigators

  • David W Roberts, MD · Dartmouth-Hitchcock Medical Center

  • Keith Paulsen, PhD · Dartmouth-Hitchcock Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2012-07-02
Completion
2013-07-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00870779 on ClinicalTrials.gov