Fluorescein vs. iMRI in Resection of Malignant High Grade Glioma

NCT02540135 | Withdrawn

• 1 other identifier: 15-1313
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

High Grade Malignant Neoplasm; Glioblastoma Multiforme; Anaplastic Astrocytoma

Keywords

high grade glioma; glioblastoma multiforme; anaplastic astrocytoma; flourescein; flourescence-guided surgery; intraoperative MRI; iMRI

Outcome Measures

Primary Outcomes (1)

• Extent of resection

  This outcome will utilize tumor volumetry of residual enhancing tumor after resection.

  36 hours

Secondary Outcomes (1)

• Surgical time difference

  36 hours

Study Arms (2)

Arm A

EXPERIMENTAL

Flourescein plus intraoperative MRI

Other: fluorescein; Other: intraoperative MRI

Arm B

ACTIVE COMPARATOR

intraoperative MRI alone

Other: intraoperative MRI

Interventions

fluorescein OTHER

fluorescein and conventional neuro-navigation

Arm A

intraoperative MRI OTHER

conventional neuro-navigation and iMRI

Also known as: iMRI

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presents with presumed or pathologically proven enhancing primary or secondary high grade glioma for surgical resection
• Eligible for gross total resection of enhancing component of tumor
• Karnofsy performance status \>/= 70%

You may not qualify if:

• Presence of multi-focal disease
• Disease that crosses the mid-line
• History of adverse reaction to flourescein
• Known ongoing pregnancy
• Inability to grant consent
• Contraindication to perform iMRI
• Contraindication to flourescein

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Glioblastoma; Astrocytoma; Glioma

Interventions

Fluorescein

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• David R Ormond, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 3, 2015
• Study Start: March 1, 2015
• Primary Completion: July 18, 2018
• Study Completion: July 18, 2018
• Last Updated: July 20, 2018

Record last verified: 2018-07

Locations

US (1)