GliomaNCT06417372
Intraoperative Fluorescent Staining Combined With Microsurgery for Gliomas
An observational study of Glioma, run by First Affiliated Hospital, Sun Yat-Sen University.
Trial summary
Through the modified formulation of sodium fluorescein and methylene blue, the surface of the suspected cut edge of the patient's glioma was stained intraoperatively, and the surgical microscope image acquisition and processing system was used to determine whether the cut edge of the surgically resected tissue was… Read more about this study
- Who is it for?
- Ages 5 to 90 years
- Conditions the study is for
- Glioma
- What is being tested?
- intraoperative fluorescent staining combined with microscopy
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2024to 31 Dec 2025
- 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 5 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Diagnosed glioma patients who will undergo surgical treatment in the First Affiliated Hospital of Sun Yet-Sen Universtiy.
Who may be able to join
- any gender, age 5-90 years old;
- patients with a confirmed diagnosis of glioma (primary tumor or metastatic tumor) by imaging or biopsy;
- patients who can tolerate the surgery by preoperative evaluation; the expected volume of tumor specimen to be resected intraoperatively is more than 1cm3;
- subjects who voluntarily enroll in the study, sign the informed consent form, and have a good adherence to the study and cooperate with the follow-up visits;
- patients with expected survival of not less than 12 months as judged by clinician; and 6. patients who are not in the clinical trial. The expected survival period, as judged by the clinician, is not less than 12 months.
Who cannot join
- Serious or unstable diseases of the heart, lungs, kidneys and hematopoietic system that cannot tolerate surgery
- Pregnant or lactating women
- Other factors that, in the judgment of the investigator, could lead to termination of the study, such as other serious medical conditions or serious laboratory abnormalities or other family or social factors that would affect the safety of the subject or the collection of test data and samples.
About this study
Official title: Prospective Study of the Effect of Intraoperative Fluorescent Staining Combined With Microscopy on the Prognosis of Patients With Gliomas
Through the modified formulation of sodium fluorescein and methylene blue, the surface of the suspected cut edge of the patient's glioma was stained intraoperatively, and the surgical microscope image acquisition and processing system was used to determine whether the cut edge of the surgically resected tissue was positive or not. And combined with the existing multimodal surgical techniques (imaging, electrophysiology, neuronavigation and other equipment), the glioma is precisely resected.
- Conditions
- Glioma
- Being tested
- intraoperative fluorescent staining combined with microscopy
- Keywords
- glioma
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoperative fluorescent staining combined with microscopyDiagnostic test
Through the modified formulation of sodium fluorescein and methylene blue, the surface of the suspected cut edge of the patient's glioma was stained intraoperatively, and the surgical microscope image acquisition and processing system was used to determine whether the cut edge of the surgically resected tissue was positive or not.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | 1. any gender, age 18-60 years old;
2. patients with a confirmed diagnosis of glioma (primary tumor or metastatic tumor) by imaging or biopsy;
3. patients who can tolerate the surgery by preoperative evaluation; the expected volume of tumor specimen to be resected intraoperatively is more than 1cm3;
4. subjects who voluntarily enroll in the study, sign the informed consent form, and have a good adherence to the study and cooperate with the follow-up visits;
5. patients with expected survival of not less than 12 months as judged by clinician; and 6. patients who are not in the clinical trial. The expected survival period, as judged by the clinician, is not less than 12 months. Receives: Diagnostic Test: intraoperative fluorescent staining combined with microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
progression-free survival (PFS): From date of randomization until the date of first documented progression
Measured: From date of randomization until the date of first documented progression, assessed up to 12 months
overall survival (OS)
overall survival (OS): From date of randomization until the date of death from any cause
Measured: From date of randomization until the date of death from any cause, assessed up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start15 May 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Nu, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417372
- Sponsor's protocol ID
- [2023]670-FM
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the Effect of Intraoperative Fluorescent Staining Combined With Microscopy on the Prognosis of Patients With Gliomas
- ClinicalTrials.gov ID
- NCT06417372
- Acronym / sponsor ID
- [2023]670-FM
- Conditions
- Glioma
- Keywords
- glioma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 May 2024 (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.
Through the modified formulation of sodium fluorescein and methylene blue, the surface of the suspected cut edge of the patient's glioma was stained intraoperatively, and the surgical microscope image acquisition and processing system was used to determine whether the cut edge of the surgically resected tissue was positive or not. And combined with the existing multimodal surgical techniques (imaging, electrophysiology, neuronavigation and other equipment), the glioma is precisely resected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Diagnostic Test: intraoperative fluorescent staining combined with microscopy1. any gender, age 18-60 years old; 2. patients with a confirmed diagnosis of glioma (primary tumor or metastatic tumor) by imaging or biopsy; 3. patients who can tolerate the surgery by preoperative evaluation; the expected volume of tumor specimen to be resected intraoperatively is more than 1cm3; 4. subjects who voluntarily enroll in the study, sign the informed consent form, and have a good adherence to the study and cooperate with the follow-up visits; 5. patients with expected survival of not less than 12 months as judged by clinician; and 6. patients who are not in the clinical trial. The expected survival period, as judged by the clinician, is not less than 12 months. |
Who may qualify
- Ages
- 5 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Diagnosed glioma patients who will undergo surgical treatment in the First Affiliated Hospital of Sun Yet-Sen Universtiy.
Key inclusion criteria (5 listed)
- any gender, age 5-90 years old;
- patients with a confirmed diagnosis of glioma (primary tumor or metastatic tumor) by imaging or biopsy;
- patients who can tolerate the surgery by preoperative evaluation; the expected volume of tumor specimen to be resected intraoperatively is more than 1cm3;
- subjects who voluntarily enroll in the study, sign the informed consent form, and have a good adherence to the study and cooperate with the follow-up visits;
- patients with expected survival of not less than 12 months as judged by clinician; and 6. patients who are not in the clinical trial. The expected survival period, as judged by the clinician, is not less than 12 months.
Key exclusion criteria (3 listed)
- Serious or unstable diseases of the heart, lungs, kidneys and hematopoietic system that cannot tolerate surgery
- Pregnant or lactating women
- Other factors that, in the judgment of the investigator, could lead to termination of the study, such as other serious medical conditions or serious laboratory abnormalities or other family or social factors that would affect the safety of the subject or the collection of test data and samples.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intraoperative fluorescent staining combined with microscopyThrough the modified formulation of sodium fluorescein and methylene blue, the surface of the suspected cut edge of the patient's glioma was stained intraoperatively, and the surgical microscope image acquisition and processing system was used to determine whether the cut edge of the surgically resected tissue was positive or not. | Diagnostic test | experimental group |
Primary outcome
progression-free survival (PFS)
Time frame: From date of randomization until the date of first documented progression, assessed up to 12 months
progression-free survival (PFS): From date of randomization until the date of first documented progression
overall survival (OS)
Time frame: From date of randomization until the date of death from any cause, assessed up to 18 months
overall survival (OS): From date of randomization until the date of death from any cause
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma, run by First Affiliated Hospital, Sun Yat-Sen University.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
progression-free survival (PFS) (time frame: From date of randomization until the date of first documented progression, assessed up to 12 months). 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 16 May 2024.