GlioblastomaNCT03293888
Spectral Analysis Probe to Identify Glioblastoma Cells
An observational study of Glioblastoma, run by University of Oklahoma at 1 site in United States.
Trial summary
This is a pilot, observational study to evaluate the intraoperative sensitivity of the Chaos Wand in detecting tumor tissue with glioblastoma disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2017to 30 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: 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.
Read the 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.
- Conditions
- Glioblastoma
- Keywords
- Spectral Diagnosis Probe, Chaos Wand, Spectral Analysis, Optical Spectroscopy
- Medical subject headings
- Glioblastoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
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.
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.
Measured: Up to 1 month following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start31 Oct 2017
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Why it stopped: PI Relocation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Sughrue, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293888
- Sponsor's protocol ID
- 8285
- Status last verified
- Jan 2019
- First submitted
- 12 Sep 2017
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Utilizing a Spectral Analysis Probe to Identify Glioblastoma Cells in Patients With Glioblastoma Undergoing Standard Surgical Resection
- ClinicalTrials.gov ID
- NCT03293888
- Acronym / sponsor ID
- 8285
- Conditions
- Glioblastoma
- Keywords
- Spectral Diagnosis Probe, Chaos Wand, Spectral Analysis, Optical Spectroscopy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI Relocation
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean ratio of detecting glioblastoma cancer between the Chaos Wand spectral readings and histopathology as ground truth
Time frame: 6 months
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.
3 secondary outcomes
Number of participants experiencing post-operative intracranial hemorrhage following surgical resection of glioblastoma with use of the Chaos Wand during surgery
Time frame: 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
Time frame: 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
Time frame: Up to 1 month following surgery
Results and safety
The study was stopped early (reason given: PI Relocation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Sughrue, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI Relocation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean ratio of detecting glioblastoma cancer between the Chaos Wand spectral readings and histopathology as ground truth (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.