Fluorescein vs. iMRI in Resection of Malignant High Grade Glioma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-01

Study Completion Date

2018-07-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Magnetic Resonance Fingerprinting Guided Extended Resection in Glioblastomas

NCT06455189

Glioblastoma Brain Tumor

NOT_YET_RECRUITING PHASE1

Impact of iMRI on the Extent of Resection in Patients With Newly Diagnosed Glioblastomas

NCT02379572

Glioblastoma

COMPLETED NA

Safety and Feasibility of Preoperative and Intraoperative Image-Guided Resection of Gliomas

NCT03542409

Brain Tumor Adult

ACTIVE_NOT_RECRUITING NA

Magnetic Resonance (MR) Imaging to Determine High Risk Areas in Patients With Malignant Gliomas and to Design Potential Radiation Plans and to Examine Metabolite Changes in Gliomas and Other Solid Tumors

NCT00870129

Brain Cancer Glioma

RECRUITING NA

Ferumoxytol- and Gadolinium-Labeled MRI in Measuring Tumors Before or After Treatment in Patients With Primary or Metastatic Brain Tumors

NCT00659126

Metastatic Malignant Neoplasm in the Brain Primary Brain Neoplasm

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Extent of surgical resection of malignant high grade glioma has been established as one of the most important predictors of overall survival and six-month progression free survival. Unfortunately, it is often difficult in surgery to distinguish between tumor and normal brain. Various technologies have been developed to help the surgeon more readily safely increase extent of resection in order to achieve an improved survival after glioblastoma resection. Fluorescein has been used at some institutions for a number of years to improve visualization of high-grade gliomas enabling their better resection. Intraoperative MRI has also been developed with similar intent, allowing the patient to be imaged intraoperatively to determine extent of resection and any need for further resection prior to leaving the operating room. While there is some evidence these technologies improve extent of resection in comparison to historical controls, they have never been tested against each other in any prospective fashion.

Intraoperative MRI has significant cost and significantly increases operative time. Fluorescein is a very inexpensive injectable agent and, if as good at achieving gross total resection as intraoperative MRI, would offer patients similar surgical outcomes with less anesthetic time and cost than intraoperative MRI. This study aims to investigate the value of fluorescein or intraoperative MRI in malignant glioma patients' extent of tumor resection in a prospectively randomized manner.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

High Grade Malignant Neoplasm Glioblastoma Multiforme Anaplastic Astrocytoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A

Flourescein plus intraoperative MRI

Group Type EXPERIMENTAL

fluorescein

Intervention Type OTHER

fluorescein and conventional neuro-navigation

intraoperative MRI

Intervention Type OTHER

conventional neuro-navigation and iMRI

Arm B

intraoperative MRI alone

Group Type ACTIVE_COMPARATOR

intraoperative MRI

Intervention Type OTHER

conventional neuro-navigation and iMRI

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fluorescein

fluorescein and conventional neuro-navigation

Intervention Type OTHER

intraoperative MRI

conventional neuro-navigation and iMRI

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

iMRI

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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%

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No