Intraoperative Fluorescent Staining Combined With Microsurgery for Gliomas

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Intraoperative Fluorescent Staining Combined With Microsurgery for Gliomas

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	5 Years - 90 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. any gender, age 5-90 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.

Exclusion Criteria:

1. Serious or unstable diseases of the heart, lungs, kidneys and hematopoietic system that cannot tolerate surgery. 2. Pregnant or lactating women. 3. 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06417372
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	First Affiliated Hospital, Sun Yat-Sen University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma

Arms & Interventions

Arms

: 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.