Glioblastoma MultiformeNCT04780009
Loupe-Based Intraoperative Fluorescence Imaging
An observational study of Glioblastoma Multiforme and Anaplastic Astrocytoma, run by Guoqiang Yu at 1 site in United States.
Trial summary
Glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA) are the most common primary malignant brain tumors. Survival of patients with these brain tumors is directly related to the extent of resection. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Glioblastoma Multiforme, Anaplastic Astrocytoma
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2017to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing glioblastoma multiforme and anaplastic astrocytoma resection recruited from the University of Kentucky Multidisciplinary Oncology Clinic (UK-MOC).
Who may be able to join
- adults with brain malignant gliomas undergoing resection
- at least 18 years of age
- able to understand the consent
Who cannot join
- pregnant women
- under 18 years of age
- patients undergoing emergency surgery
- inability to give consent due to dysphagia or language barrier
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Thomas Pittman, MD, 859-323-8986, thomas.pittman@uky.edu
Thomas Pittman, MD
About this study
Official title: Loupe-Based Intraoperative Fluorescence Imaging for the Guidance of Brain Tumor Surgery
Glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA) are the most common primary malignant brain tumors. Survival of patients with these brain tumors is directly related to the extent of resection. Consequently, a great deal of effort has been directed at developing techniques and technologies that allow more extensive, safe resections.
This study will test a loupe-based wearable device in the clinical setting and compare its accuracy with a large operative microscope to identify tumor tissues. Postoperative histopathological analysis on tumor tissues will be used as gold standards for comparison. The outcome from this study will be a low-cost, miniaturized, easy-to-operate, loupe-based fluorescence imaging device for intraoperative guidance of brain tumor resection with the same level of accuracy as the large microscope.
Read the detailed description
This is a prospective, observational study to compare the measurement accuracies of a wearable loupe-based device and the large microscope against the gold standards of postoperative histopathological analysis on tumor tissues.
At the induction of anesthesia, patients will receive 5 mg/kg of intravenous sodium 5-aminolevulinic acid (5-ALA) or fluorescein. Surgery will be performed under the guidance of the operative fluorescence microscope (PENTERO with fluorescence kit + YELLOW 560, Carl Zeiss) or (PENTERO 900 + BLUE 400, Carl Zeiss). The operating room light will be dimmed for optimum reproduction of the fluorescent light. Tumor removal will be continued until no fluorescent area is visualized. To evaluate the accuracy of the device in the identification of tumor tissue, six samples will be biopsied from the tumor resection margin for each patient; three in the fluorescent area and three in the non-fluorescent area for the assessment of positive and negative predictive values of the devices, respectively. These biopsied tissues will be taken to the clinical pathology laboratory for the standard histological analysis.
To compare the accuracy of the two imaging systems in identifying tumor tissues, the tumor resection area will be visually observed by the surgeon and video recorded using the new loupe-based device at two time points (at least): immediately before and immediately after tumor removal. Additional fluorescence images may be taken during surgery as long as the surgical workflow is not impacted. Moreover, the four fresh biopsies (2 in the fluorescent area and 2 in the non-fluorescent area) taken from the tumor margin based on the operative microscope diagnosis will also be examined intraoperatively by the loupe-based device to determine whether they are fluorescent or non-fluorescent.
To discriminate between clear tumor tissue and the peritumoral areas, the postoperative histological analysis of the biopsied samples taken from the tumor margins will be classified on the basis of the current 2016 WHO classification. The neuropathologist will be blinded to the fluorescence characteristics of the biopsied samples.
- Conditions
- Glioblastoma Multiforme, Anaplastic Astrocytoma
- Keywords
- fluorescence, resection, 5-ALA, fluorescein, optical
- Medical subject headings
- Glioblastoma, Astrocytoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Predictive Value (PPV)
The proportion of samples that are histologically confirmed as tumor-positive among all fluorescent samples will be calculated.
Measured: 1 day
Negative Predictive Value (NPV)
The proportion of samples that are histologically confirmed as tumor-negative among all fluorescent samples will be calculated.
Measured: 1 day
Secondary outcomes (1)
Residual Tumor
The proportion of positive results among all tumors with residual as well as the proportion of negative results among tumors without residual will be calculated relative to post-operative histopathological analysis.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start17 Nov 2017
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guoqiang Yu
- Sponsor type
- University, hospital or other
- Collaborators
- Bioptics Technology LLC, National Cancer Institute (NCI), Kentucky Small Business Innovation Research / Small Business Technology Transfer (SBIR/STTR)
- Responsible party
- Sponsor-investigator, Guoqiang Yu, University of Kentucky
- Investigators
- Guoqiang Yu, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780009
- Sponsor's protocol ID
- MCC-17-0605-F1V
- Other IDs
- R41CA243600-01
- Status last verified
- Jun 2026
- First submitted
- 26 Feb 2021
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loupe-Based Intraoperative Fluorescence Imaging for the Guidance of Brain Tumor Surgery
- ClinicalTrials.gov ID
- NCT04780009
- Acronym / sponsor ID
- MCC-17-0605-F1V
- Conditions
- Glioblastoma Multiforme, Anaplastic Astrocytoma
- Keywords
- fluorescence, resection, 5-ALA, fluorescein, optical
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Guoqiang YuUniversity, hospital or other
- Collaborators
- Bioptics Technology LLC, National Cancer Institute (NCI), Kentucky Small Business Innovation Research / Small Business Technology Transfer (SBIR/STTR)
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 3 Mar 2021 (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.
Glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA) are the most common primary malignant brain tumors. Survival of patients with these brain tumors is directly related to the extent of resection. Consequently, a great deal of effort has been directed at developing techniques and technologies that allow more extensive, safe resections.
This study will test a loupe-based wearable device in the clinical setting and compare its accuracy with a large operative microscope to identify tumor tissues. Postoperative histopathological analysis on tumor tissues will be used as gold standards for comparison. The outcome from this study will be a low-cost, miniaturized, easy-to-operate, loupe-based fluorescence imaging device for intraoperative guidance of brain tumor resection with the same level of accuracy as the large microscope.
Detailed description
This is a prospective, observational study to compare the measurement accuracies of a wearable loupe-based device and the large microscope against the gold standards of postoperative histopathological analysis on tumor tissues.
At the induction of anesthesia, patients will receive 5 mg/kg of intravenous sodium 5-aminolevulinic acid (5-ALA) or fluorescein. Surgery will be performed under the guidance of the operative fluorescence microscope (PENTERO with fluorescence kit + YELLOW 560, Carl Zeiss) or (PENTERO 900 + BLUE 400, Carl Zeiss). The operating room light will be dimmed for optimum reproduction of the fluorescent light. Tumor removal will be continued until no fluorescent area is visualized. To evaluate the accuracy of the device in the identification of tumor tissue, six samples will be biopsied from the tumor resection margin for each patient; three in the fluorescent area and three in the non-fluorescent area for the assessment of positive and negative predictive values of the devices, respectively. These biopsied tissues will be taken to the clinical pathology laboratory for the standard histological analysis.
To compare the accuracy of the two imaging systems in identifying tumor tissues, the tumor resection area will be visually observed by the surgeon and video recorded using the new loupe-based device at two time points (at least): immediately before and immediately after tumor removal. Additional fluorescence images may be taken during surgery as long as the surgical workflow is not impacted. Moreover, the four fresh biopsies (2 in the fluorescent area and 2 in the non-fluorescent area) taken from the tumor margin based on the operative microscope diagnosis will also be examined intraoperatively by the loupe-based device to determine whether they are fluorescent or non-fluorescent.
To discriminate between clear tumor tissue and the peritumoral areas, the postoperative histological analysis of the biopsied samples taken from the tumor margins will be classified on the basis of the current 2016 WHO classification. The neuropathologist will be blinded to the fluorescence characteristics of the biopsied samples.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing glioblastoma multiforme and anaplastic astrocytoma resection recruited from the University of Kentucky Multidisciplinary Oncology Clinic (UK-MOC).
Key inclusion criteria (3 listed)
- adults with brain malignant gliomas undergoing resection
- at least 18 years of age
- able to understand the consent
Key exclusion criteria (4 listed)
- pregnant women
- under 18 years of age
- patients undergoing emergency surgery
- inability to give consent due to dysphagia or language barrier
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
Positive Predictive Value (PPV)
Time frame: 1 day
The proportion of samples that are histologically confirmed as tumor-positive among all fluorescent samples will be calculated.
Negative Predictive Value (NPV)
Time frame: 1 day
The proportion of samples that are histologically confirmed as tumor-negative among all fluorescent samples will be calculated.
1 secondary outcome
Residual Tumor
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Guoqiang Yu, PhD principal investigator
University of Kentucky
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 Multiforme and Anaplastic Astrocytoma, run by Guoqiang Yu 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 4 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: looking for participants now, as of the sponsor's last update on 3 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Predictive Value (PPV) (time frame: 1 day). The study lists 2 primary outcomes in all. 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 3 Jun 2026.