Spectral Analysis Probe to Identify Glioblastoma Cells

Pilot Study Utilizing a Spectral Analysis Probe to Identify Glioblastoma Cells in Patients With Glioblastoma Undergoing Standard Surgical Resection

This is a pilot, observational study to evaluate the intraoperative sensitivity of the Chaos Wand in detecting tumor tissue with glioblastoma disease.

Study Overview

• Status: Terminated
• Conditions: Glioblastoma

Detailed Description

This is a pilot study to investigate if the Chaos Wand Spectral Diagnosis Probe can be used to identify Glioblastoma (GBM) cancer cells in patients undergoing standard surgical resection. Eligible patients who have consented to the use of the Chaos Wand will be scheduled for surgery as standard cancer care for GBM. During the surgical procedure, the Chaos Wand Spectral Diagnosis Probe will be utilized. Fifteen intraoperative readings and signal recordings of GBM tissue will be taken. The wand will only be used in areas that have already been deemed in need of resection due to GBM disease. Each site identified for spectral analysis will be marked. The wand does not come into contact with the brain at any point during this procedure. Following surgical resection of the GBM tumor, tissue will be collected from the same 15 sites where the Chaos Wand was used. The pathology report will be compared with the results of spectral analysis.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population includes adult patients from the outpatient neurosurgery clinic or those who have presented through the University of Oklahoma emergency department and have been diagnosed with glioblastoma or are suspected of having glioblastoma based on pre-operative imaging. The Stephenson Cancer Center will not exclude potential subjects from participating in this or any study solely on the basis of ethnic origin or socioeconomic status. Every attempt will be made to enter all eligible patients into this protocol and therefore address the study objectives in a patient population representative of the entire patient population with GBM.

Description

Inclusion Criteria:

1. Male or Female and over 18 years of age.
2. Patients with histologically proven GBM who are newly diagnosed and eligible to undergo surgical treatment or patients who are suspected of having glioblastoma on pre-operative imaging which is subsequently confirmed by histopathology following tumor resection.
3. Patients must be able to understand and willing to sign the informed consent document.

Exclusion Criteria:

1. Patients with absence of glioblastoma.
2. Patients who are not undergoing tumor resection.
3. Patients who have prior brain radiotherapy
4. Patients who have prior systemic chemotherapy
5. Patients who are not willing to sign the informed consent and agree to participate.
6. Patients who are pregnant or nursing

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean ratio of detecting glioblastoma cancer between the Chaos Wand spectral readings and histopathology as ground truth	For participants newly diagnosed with glioblastoma multiforme or patients who are suspected of having glioblastoma on pre-operative imaging who consent to the use of the Chaos Wand during surgery, 15-20 spectral readings will be compared to histopathology as ground truth to measure the sensitivity of the Chaos Wand to detect glioblastoma. For example, if a patient has 15 spectral readings but only 13 are histologically consistent with cancer, then the sensitivity of the wand would be 13/15*100 = 87%. A mean value with standard deviation will be reported across all participants in the study.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants experiencing post-operative intracranial hemorrhage following surgical resection of glioblastoma with use of the Chaos Wand during surgery	For participants newly diagnosed with glioblastoma multiforme or are suspected of having glioblastoma based on pre-operative imaging who consent to the use of the Chaos Wand during surgery, the number of cases of intracranial hemorrhage during the post-operative hospital course will be measured.	Up to 1 month following surgery
Number of participants experiencing post-operative ischemic stroke following surgical resection of glioblastoma with use of the Chaos Wand during surgery	For participants newly diagnosed with glioblastoma multiforme or are suspected of having glioblastoma based on pre-operative imaging who consent to the use of the Chaos Wand during surgery, the number of cases of ischemic stroke during the post-operative hospital course will be measured.	Up to 1 month following surgery
Number of participants experiencing post-operative surgical site infection following surgical resection of glioblastoma with use of the Chaos Wand during surgery	For participants newly diagnosed with glioblastoma multiforme or are suspected of having glioblastoma based on pre-operative imaging who consent to the use of the Chaos Wand during surgery, the number of cases of surgical site infection during the post-operative hospital course will be measured.	Up to 1 month following surgery

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Michael Sughrue, MD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2017
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: September 12, 2017
• First Submitted That Met QC Criteria: September 25, 2017
• First Posted (Actual): September 26, 2017

Study Record Updates

• Last Update Posted (Actual): January 25, 2019
• Last Update Submitted That Met QC Criteria: January 24, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Optical Spectroscopy; Spectral Diagnosis Probe; Chaos Wand; Spectral Analysis
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: 8285

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No