Spectral Analysis Probe to Identify Glioblastoma Cells

NCT03293888 | Terminated DMC

• 1 other identifier: 8285
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glioblastoma

Keywords

Spectral Diagnosis Probe; Chaos Wand; Spectral Analysis; Optical Spectroscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of participants experiencing post-operative intracranial hemorrhage following surgical resection of glioblastoma with use of the Chaos Wand during surgery

  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

  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

  Up to 1 month following surgery

Eligibility Criteria

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

You may qualify if:

• Male or Female and over 18 years of age.
• 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.
• Patients must be able to understand and willing to sign the informed consent document.

You may not qualify if:

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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue from surgically resected tumor

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Sughrue, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 26, 2017
• Study Start: October 31, 2017
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: January 25, 2019

Record last verified: 2019-01

Locations

US (1)