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Fluorescein vs. iMRI in Resection of Malignant High Grade Glioma

NCT02540135 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-07-20

No results posted yet for this study

Summary

This study plans to learn more about if fluorescein with intraoperative Magnetic Resonance Imaging (MRI) is as good as intraoperative MRI (iMRI) alone in detecting the presence of tumor tissue during surgery.

Both fluorescein and intraoperative MRI have been studied and routinely used to aid the neurosurgeon in distinguishing normal brain from tumor, helping the neurosurgeon to safely resect more tumor tissue during surgery.

This study will enroll patients with malignant high grade glioma who are going to have a surgery to remove their brain tumor.

For half of the patients, fluorescein and intraoperative MRI will be used together during surgery. For half of the patients, only intraoperative MRI will be used during surgery. iMRI is used as final verification of complete, safe resection in both arms.

Conditions

Interventions

OTHER

fluorescein

fluorescein and conventional neuro-navigation

OTHER

intraoperative MRI

conventional neuro-navigation and iMRI

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • David R Ormond, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-01
Primary Completion
2018-07-18
Completion
2018-07-18

Countries

  • United States

Study Locations

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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 NCT02540135 on ClinicalTrials.gov