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Fluorescein vs. iMRI in Resection of Malignant High Grade Glioma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02540135
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Colorado, Denver
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 David R Ormond, MD
Principal Investigator Affiliation University of Colorado, Denver
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Withdrawn
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 High Grade Malignant Neoplasm, Glioblastoma Multiforme, Anaplastic Astrocytoma
Additional Details

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.

Arms & Interventions

Arms

Experimental: Arm A

Flourescein plus intraoperative MRI

Active Comparator: Arm B

intraoperative MRI alone

Interventions

Other: - fluorescein

fluorescein and conventional neuro-navigation

Other: - intraoperative MRI

conventional neuro-navigation and iMRI

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Aurora, Colorado

Status

Address

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045

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