Research on the Safety and Efficacy of Blocking Dural Blood Supply in Glioblastoma Patients

NCT05990556 | Recruiting

• 1 other identifier: ZNu
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Glioblastoma is the most common primary malignancy of the central nervous system with a very poor prognosis. Most of the immunotherapies that have made significant breakthroughs in the treatment of other tumors in recent years are unsatisfactory in the application of glioblastoma, which is mainly inseparable from the highly inhibitory immune microenvironment formed by the latter. Therefore, how to change this "immune desert" and better activate immune effector cells to play an anti-tumor effect is currently a hot spot in glioma immune research. In recent years, there has been continuous research support that the myeloid cells of the central nervous system are partly derived from the bone marrow of the skull, and there is a special channel connection between the skull and the dura mater, through which immune cells can be transported. This suggests that some of the tumor-associated macrophages recruited in the glioblastoma microenvironment may be passed through the dura mater. In previous animal experiments, we blocked the main blood supply to the dura mater by ligating the bilateral external carotid arteries of mice, cutting off the potential supply of dura mater to suppressor myeloid cells in the lesion. The results showed that after ligation of bilateral external carotid arteries, the survival period of tumor-forming mice was significantly prolonged and the prognosis was improved. The proportion of myeloid cells in the tumor microenvironment of mice decreased significantly, and the expression of tumor suppressor molecules such as arginase Arg1 decreased, indicating that the improvement of mouse prognosis was closely related to the proportion and phenotypic changes of myeloid cells after dural blood supply blockade. The meningeal lymphatic system of the human central nervous system has been shown to be an important part of the immune system, while the external carotid artery system, the main source of blood supply to the dura, carries abundant immune cells that ooze out to the dura mater through the endothelial window hole of the dural blood vessel, which is an important source of dural immune cells. In the glioblastoma immune microenvironment, the source of immune cells includes dural branches from the external carotid artery system in addition to branches of the internal carotid artery system. Therefore, for patients diagnosed with glioblastoma, this study involves embolization of the dural branch of the external carotid artery system (bilateral middle meningeal artery) to block the dural blood supply before craniotomy. At the same time, microsurgery under multimodal image navigation was used to remove the tumor. It is expected to be effective in reducing the proportion of myeloid suppressor cells in the tumor microenvironment, slowing the growth rate of residual tumor cells, and prolonging the tumor-free progression and survival of patients.

Conditions

Glioblastoma; Meningeal Arteries

Keywords

glioblastoma

Outcome Measures

Primary Outcomes (1)

• Patient survival period

  The overall survival of enrolled patients was compared with the overall survival reported in the literature

  15 months

Secondary Outcomes (1)

• Postoperative recurring time

  3-6 months

Study Arms (1)

interventional procedure to block bilateral meningeal blood supply

EXPERIMENTAL

Procedure: interventional procedure to block bilateral meningeal blood supply

Interventions

interventional procedure to block bilateral meningeal blood supply PROCEDURE

The embolic agent used in bilateral meningeal blood supply occlusion through interventional surgery is Onyx glue ("liquid embolic system"). After the location of bilateral middle meningeal artery was determined by femoral artery puncture angiography, SL-10 was sent to the opening of bilateral middle meningeal artery through guiding catheter, and Onxy glue was used to block the bilateral middle meningeal artery. The standard of embolization was that the middle meningeal artery was not seen and Onyx glue was not diffused to the petrous branch of the middle meningeal artery. In order to avoid dangerous anastomotic branches and complications, attention should be paid to superselecting the middle meningeal artery and slowly injecting Onyx glue during the operation. After embolization of the middle meningeal artery by interventional surgery, glioblastoma was removed immediately under the guidance of multimodal imaging.

interventional procedure to block bilateral meningeal blood supply

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Imaging or needle biopsy pathologically diagnosed as glioblastoma
• Patients have not previously received radiotherapy, chemotherapy and other treatment modalities for intracranial lesions
• There are no related contraindications such as neurovascular intervention and craniotomy

You may not qualify if:

• The patient's initial imaging diagnosis was glioblastoma, and the postoperative pathology confirmed nonglioblastoma
• The patient has other underlying medical conditions that affect survival time
• The patient had other underlying medical conditions that affected follow-up or quality of life assessment

Sponsors & Collaborators

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

Study Sites (1)

the First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Nu Zhang, Professor

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nu Zhang, Professor

CONTACT

13825070717; zhangnu2@mail.sysu.edu.cn

Kejun He, Attending

CONTACT

15920463410; mailto:hekejun3@ms.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Blinding and unblinding This is a real-world study that intends to include three patients as case studies without blinding prior to intervention and therefore does not involve blinding.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Discipline Leader of Neurosurgery department, Clinical Professor

Model Details: Interventional single-arm studies, no grouping. 1 Randomize groupings 1.1 Method for generating random sequence assignments This study is a real-world study, it is planned to include 20 patients as a case, there is no need for random sequence and blinded allocation before intervention, the patient's condition, experimental purpose, experimental method and possible risks are informed before surgery, and the patient chooses whether to undergo preoperative interventional surgery to block bilateral meningeal blood supply. 1.2 Randomly assigned hiding This is a real-world study that intends to include three patients as individual cases without random sequencing prior to intervention and therefore does not involve allocation concealment.

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 14, 2023
• Study Start: May 11, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

CN (1)