Prospective Study of the Effect of Intraoperative Fluorescent Staining Combined With Microscopy on the Prognosis of Patients With Gliomas
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Primary Endpoint
- overall survival (OS)
Study Overview
Brief 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 positive or not. And combined with the existing multimodal surgical techniques (imaging, electrophysiology, neuronavigation and other equipment), the glioma is precisely resected.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 5 Years to 90 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •patients who are not in the clinical trial. The expected survival period, as judged by the clinician, is not less than 12 months.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Zhang Nu
Discipline Leader of Neurosurgery department, Clinical Professor
First Affiliated Hospital, Sun Yat-Sen University