Gamma Knife Radiosurgery on Tectal Plate Gliomas | NCT07015710

Studies
Gamma Knife Radiosurgery on Tectal Plate Gliomas

NCT07015710

Sponsor

Al-Azhar University

Status

Completed

Last Update Posted

Jun 11, 2025Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Gamma Knife Radiosurgery
Tectal Plate Gliomas

Interventions

Gamma Knife Radiosurgery

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Dec 1, 2024Actual

Completion Date

Dec 1, 2024Actual

First Submitted Date

Jun 3, 2025

First Submission Date that Met QC Criteria

Jun 3, 2025

First Posted Date

Jun 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2025

Last Update Posted Date

Jun 11, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Awad Mohamed Hegab, Lecturer of Neurosurgery, Faculty of Medicine, Al-Azhar University, Damietta, Egypt., Al-Azhar UniversityPrincipal Investigator

Lead Sponsor

Al-Azhar UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aimed to assess the impact of gamma knife radiosurgery on tectal plate gliomas (TPGs).

Detailed Description

Tectal plate gliomas (TPGs) represent a subset of brainstem gliomas that are predominantly slow-growing, low-grade tumors and rarely produce neurological deficits.

Viable options include biopsy and monitoring with serial neuroimaging, surgical resection, radiotherapy (either early following surgery or late on evidence of disease progression), chemotherapy, and stereotactic radiosurgery (SRS).

SRS using Gamma Knife radiosurgery (GKRS) has been identified in small case series as a safe and promising approach for managing TPGs that necessitate intervention beyond mere observation.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tectal Plate Gliomas group		Patients underwent gamma knife radiosurgery (GKRS) for tectal plate gliomas (TPGs).	Procedure: Gamma Knife Radiosurgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gamma Knife Radiosurgery	Procedure	Patients underwent gamma knife radiosurgery (GKRS) for tectal plate gliomas (TPGs).	Tectal Plate Gliomas group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of response	Incidence of response was recorded.	One year post-procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age from 5 to 55 years.
Both sexes.
Patients underwent gamma knife radiosurgery (GKRS) for tectal plate gliomas (TPGs).

Exclusion Criteria:

High-grade glioma.
Tumor extension beyond the tectal region.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

55 Years

Standard Ages

ChildAdult

Study Population

This retrospective study will be conducted in the Department of Neurosurgery, Al-Azhar University Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Al-Azhar University (Damietta)		Damietta		0000-0001-6746-3024	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Types

Study Protocol

Time Frame

After the end of study for one year.

Access Criteria

The data will be available upon a reasonable request from the corresponding author.

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016634	Radiosurgery

Ancestor Terms

ID	Term
D011878	Radiotherapy
D013812	Therapeutics
D013238	Stereotaxic Techniques
D019635	Neurosurgical Procedures

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