Gamma Knife RadiosurgeryNCT07015710
Gamma Knife Radiosurgery on Tectal Plate Gliomas
An observational study of Gamma Knife Radiosurgery and Tectal Plate Gliomas, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study aimed to assess the impact of gamma knife radiosurgery on tectal plate gliomas (TPGs). Read more about this study
- Who is it for?
- Ages 5 to 55 years
- Conditions the study is for
- Gamma Knife Radiosurgery, Tectal Plate Gliomas
- What is being tested?
- Gamma Knife Radiosurgery
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This retrospective study will be conducted in the Department of Neurosurgery, Al-Azhar University Hospital.
Who may be able to join
- Age from 5 to 55 years.
- Both sexes.
- Patients underwent gamma knife radiosurgery (GKRS) for tectal plate gliomas (TPGs).
Who cannot join
- High-grade glioma.
- Tumor extension beyond the tectal region.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Gamma Knife Radiosurgery on Tectal Plate Gliomas
This study aimed to assess the impact of gamma knife radiosurgery on tectal plate gliomas (TPGs).
Read the 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.
- Conditions
- Gamma Knife Radiosurgery, Tectal Plate Gliomas
- Being tested
- Gamma Knife Radiosurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma Knife RadiosurgeryProcedure or surgery
Patients underwent gamma knife radiosurgery (GKRS) for tectal plate gliomas (TPGs).
| Study group | Role | What they receive |
|---|---|---|
| Tectal Plate Gliomas group | Patients underwent gamma knife radiosurgery (GKRS) for tectal plate gliomas (TPGs). Receives: Procedure: Gamma Knife Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of response
Incidence of response was recorded.
Measured: One year post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Jan 2021
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gamma Knife RadiosurgeryStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Awad Mohamed Hegab, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015710
- Sponsor's protocol ID
- DFM-IRB 00012367-25-05-007
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Gamma Knife Radiosurgery on Tectal Plate Gliomas
- ClinicalTrials.gov ID
- NCT07015710
- Acronym / sponsor ID
- DFM-IRB 00012367-25-05-007
- Conditions
- Gamma Knife Radiosurgery, Tectal Plate Gliomas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tectal Plate Gliomas group | – | Procedure: Gamma Knife RadiosurgeryPatients underwent gamma knife radiosurgery (GKRS) for tectal plate gliomas (TPGs). |
Who may qualify
- Ages
- 5 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This retrospective study will be conducted in the Department of Neurosurgery, Al-Azhar University Hospital.
Key inclusion criteria (3 listed)
- Age from 5 to 55 years.
- Both sexes.
- Patients underwent gamma knife radiosurgery (GKRS) for tectal plate gliomas (TPGs).
Key exclusion criteria (2 listed)
- High-grade glioma.
- Tumor extension beyond the tectal region.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamma Knife RadiosurgeryPatients underwent gamma knife radiosurgery (GKRS) for tectal plate gliomas (TPGs). | Procedure or surgery | Tectal Plate Gliomas group |
Primary outcome
Incidence of response
Time frame: One year post-procedure
Incidence of response was recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gamma Knife Radiosurgery and Tectal Plate Gliomas, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of response (time frame: One year post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025; AzTrials last refreshed its copy on 6 Nov 2026.