Intraoperative Fluorescent Staining Combined With Microsurgery for Gliomas

Glioma Clinical Trial

Official title:

Prospective Study of the Effect of Intraoperative Fluorescent Staining Combined With Microscopy on the Prognosis of Patients With Gliomas

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06417372
• Other study ID #: [2023]670-FM
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Glioma

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