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More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery

NCT01445691 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2016-05-17

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and utility of 5-aminolevulinic acid (ALA) for identifying your tumor during surgery. 5-ALA is not FDA approved at this time. When the investigators remove the tumor from your brain, it is important that they remove all of the tumor and not remove parts of normal brain. Sometimes this can be difficult because the tumor can look like normal brain. In some brain tumors, 5-ALA can make the tumors glow red under blue light. This may make it easier for your doctor to take out all of the tumor from your brain. The purpose of this study is to:

* Make sure that 5-ALA helps the doctor remove more of the tumor.
* Make sure 5-ALA does not cause any side effects.

If you do not want to participate in this study, your doctor(s) will still do their best to remove all of the tumor in your brain. Whether or not you join this study will not change your treatment for your brain tumor.

Conditions

  • Benign Neoplasms, Brain
  • Brain Cancer
  • Brain Neoplasms, Benign
  • Brain Neoplasms, Malignant
  • Brain Tumor, Primary
  • Brain Tumor, Recurrent
  • Brain Tumors
  • Intracranial Neoplasms
  • Neoplasms, Brain
  • Neoplasms, Intracranial
  • Primary Brain Neoplasms
  • Primary Malignant Brain Neoplasms
  • Primary Malignant Brain Tumors
  • Gliomas
  • Glioblastoma

Interventions

DRUG

5-ALA (Gliolan)

20 mg/kg administered once 3-5 hours prior to surgery

Sponsors & Collaborators

  • NX PharmaGen

    collaborator UNKNOWN

  • National Cancer Institute (NCI)

    collaborator NIH

  • Constantinos Hadjipanayis

    lead OTHER

Principal Investigators

  • Costas Hadjipanayis, MD, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-09-30
Completion
2016-09-30

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 NCT01445691 on ClinicalTrials.gov