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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06417372
Other study ID # [2023]670-FM
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 15, 2024
Est. completion date December 31, 2025

Study information

Verified date May 2024
Source First Affiliated Hospital, Sun Yat-Sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 positive or not. And combined with the existing multimodal surgical techniques (imaging, electrophysiology, neuronavigation and other equipment), the glioma is precisely resected.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 5 Years to 90 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
intraoperative fluorescent staining combined with microscopy
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Outcome

Type Measure Description Time frame Safety issue
Primary progression-free survival (PFS) progression-free survival (PFS): From date of randomization until the date of first documented progression From date of randomization until the date of first documented progression, assessed up to 12 months
Primary overall survival (OS) overall survival (OS): From date of randomization until the date of death from any cause From date of randomization until the date of death from any cause, assessed up to 18 months
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