Clinical trial NCT03293888: Spectral Analysis Probe to Identify Glioblastoma Cells
Official title: Pilot Study Utilizing a Spectral Analysis Probe to Identify Glioblastoma Cells in Patients With Glioblastoma Undergoing Standard Surgical Resection
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Glioblastoma
Keywords: Spectral Diagnosis Probe
Chaos Wand
Spectral Analysis
Optical Spectroscopy
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean ratio of detecting glioblastoma cancer between the Chaos Wand spectral readings and histopathology as ground truth
timeFrame: 6 months
Secondary outcomes:
measure: Number of participants experiencing post-operative intracranial hemorrhage following surgical resection of glioblastoma with use of the Chaos Wand during surgery
timeFrame: Up to 1 month following surgery
measure: Number of participants experiencing post-operative ischemic stroke following surgical resection of glioblastoma with use of the Chaos Wand during surgery
timeFrame: Up to 1 month following surgery
measure: Number of participants experiencing post-operative surgical site infection following surgical resection of glioblastoma with use of the Chaos Wand during surgery
timeFrame: Up to 1 month following surgery
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Michael Sughrue, MD
role: PRINCIPAL_INVESTIGATOR
References: