Intraoperative Fluorescent Staining Combined With Microsurgery for Gliomas

NCT06417372 | Not Yet Recruiting

• 1 other identifier: [2023]670-FM
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glioma

Keywords

glioma

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

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.

Diagnostic Test: intraoperative fluorescent staining combined with microscopy

Interventions

intraoperative fluorescent staining combined with microscopy DIAGNOSTIC_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.

experimental group

Eligibility Criteria

• Age: 5 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Diagnosed glioma patients who will undergo surgical treatment in the First Affiliated Hospital of Sun Yet-Sen Universtiy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

MeSH Terms

Conditions

Glioma

Interventions

Microscopy

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Discipline Leader of Neurosurgery department, Clinical Professor

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 16, 2024
• Study Start: May 15, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05